SecProbe.io

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 February 13, 2026

Avi Minkowitz
Chief Executive Officer
KALA BIO, Inc.
1167 Massachusetts Avenue
Arlington, MA 02476

 Re: KALA BIO, Inc.
 Registration Statement on Form S-3
 Filed February 10, 2026
 File No. 333-293323
Dear Avi Minkowitz:

 This is to advise you that we have not reviewed and will not review your
registration
statement.

 Please refer to Rules 460 and 461 regarding requests for acceleration.
We remind you
that the company and its management are responsible for the accuracy and
adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action
by the staff.

 Please contact Tim Buchmiller at 202-551-3635 with any questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Life
Sciences
cc: Rick A. Werner, Esq.
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CORRESP
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 filename1.htm

 KALA
BIO, Inc.

 1167
Massachusetts Avenue

 Arlington,
MA 02476

 February
13, 2026

 VIA EDGAR

 Division of Corporation Finance

 Office of Life Sciences

 U.S. Securities and Exchange Commission

 Washington, D.C. 20549

 Attention:
Tim Buchmiller

 Re:
 KALA
 BIO, Inc.
 Registration
 Statement on Form S-3
 Originally
 filed on February 10, 2026
 File
 No. 333-293323 (the " Registration Statement ")
 Request
 for Acceleration

 Ladies
and Gentlemen:

 Pursuant
to Rule 461 of the Rules and Regulations of the Securities and Exchange Commission (the " Commission ") under
the Securities Act of 1933, as amended, KALA BIO, Inc. (the " Company "), hereby respectfully requests acceleration
of the effective date of the Registration Statement, so that it may become effective at 4:00 p.m., Eastern Time, on February 17, 2026,
or as soon thereafter as practicable.

 Should
any member of the staff of the Commission have any questions or comments with respect to this request, please contact our counsel, Haynes
and Boone, LLP, attention: Bruce Newsome, Esq. at (214) 651.5119.

 Very
 truly yours,

 KALA
 BIO, Inc.

 By:
 /s/
 Avi Minkowitz

 Avi
 Minkowitz

 Chief
 Executive Officer

 cc:
 Bruce
 Newsome, Esq., Haynes and Boone, LLP

CORRESP
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January 31, 2025

VIA EDGAR SUBMISSION

U.S. Securities and Exchange Commission

Division of Corporation Finance, Office of Life Sciences

100 F Street, NE

Washington, DC 20549

Attention: 	Daniel Crawford

Re:     KALA BIO, Inc.
Registration Statement on Form S-3
Filed January 24, 2025

File No. 333-284480
Request for Acceleration

Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities Act of 1933, as amended,
KALA BIO, Inc. (the “Registrant”) hereby requests acceleration of the effective date of its Registration Statement
on Form S-3 (File No. 333-284480), so that it may become effective at 4:00 p.m., Eastern Time, on February 4, 2025, or as soon as practicable
thereafter, or at such later time as the Registrant or its counsel may orally request via telephone call to the staff of the U.S. Securities
and Exchange Commission.

    Very truly yours,

    KALA BIO, INC.

    By:
    /s/ Mary Reumuth

    Name:
    Mary Reumuth

    Title:
    Chief Financial Officer and Corporate Secretary

January 31, 2025
Mark Iwicki
Chief Executive Officer and Chair of Board of Directors
KALA BIO, Inc.
1167 Massachusetts Avenue
Arlington, MA 02476
Re:KALA BIO, Inc.
Registration Statement on Form S-3
Filed January 24, 2025
File No. 333-284480
Dear Mark Iwicki:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Daniel Crawford at 202-551-7767 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Andrea Sorrentino, Esq.

CORRESP
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July 29, 2024

VIA EDGAR SUBMISSION

U.S. Securities and Exchange Commission

Division of Corporation Finance, Office of Life Sciences

100 F Street, NE

Washington, DC 20549

Attention:        Tamika
N. Sheppard

Re: KALA BIO, Inc.
Registration Statement on Form S-3
Filed July 25, 2024

  File No. 333-281006

  Request for Acceleration

Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities Act of 1933, as amended,
KALA BIO, Inc. (the “Registrant”) hereby requests acceleration of the effective date of its Registration Statement
on Form S-3 (File No. 333-281006 ), so that it may become effective at 4:00 p.m., Eastern Time, on July 31, 2024, or as
soon as practicable thereafter, or at such later time as the Registrant or its counsel may orally request via telephone call to the staff
of the U.S. Securities and Exchange Commission.

    Very truly yours,

    KALA BIO, INC.

    By:
    /s/ Mary Reumuth

    Name:
    Mary Reumuth

    Title:
    Chief Financial Officer and Corporate Secretary

July 26, 2024
Mark Iwicki
Chief Executive Officer
Kala Bio, Inc.
1167 Massachusetts Avenue
Arlington, MA 02476
Re:Kala Bio, Inc.
Registration Statement on Form S-3
Filed July 25, 2024
File No. 333-281006
Dear Mark Iwicki:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that
the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Tamika Sheppard at 202-551-8346 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Andrea Sorrentino

CORRESP
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May 9, 2023

VIA EDGAR SUBMISSION

U.S. Securities and Exchange Commission

Division of Corporation Finance, Office of Life Sciences

100 F Street, NE

Washington, DC 20549

Attention: Daniel Crawford

 Re: Kala Pharmaceuticals, Inc.

Registration Statement on Form S-3

Filed March 3, 2023
File No. 333-270263
Request for Acceleration

Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities Act of 1933, as amended,
Kala Pharmaceuticals, Inc. hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-270263),
so that it may become effective at 4:00 p.m., Eastern Time, on May 11, 2023, or as soon as practicable thereafter.

    Very truly yours,

 KALA
    PHARMACEUTICALS, INC.

    By:
    /s/ Eric L. Trachtenberg

    Name: Eric L. Trachtenberg

    Title: General Counsel, Chief Compliance
    Officer and Corporate Secretary

CORRESP
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March 10, 2023

VIA EDGAR SUBMISSION

U.S. Securities and Exchange Commission

Division of Corporation Finance, Office of Life Sciences

100 F Street, NE

Washington, DC 20549

Attention:	     Daniel
Crawford

Re: Kala Pharmaceuticals, Inc.

                                                                Registration Statement on Form S-3

                                                                Filed March 3, 2023

File No. 333-270266

Request for Acceleration

Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities Act of 1933, as amended,
Kala Pharmaceuticals, Inc. hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File
No. 333-270266), so that it may become effective at 4:00 p.m., Eastern Time, on March 14, 2023, or as soon as practicable thereafter.

  Very truly yours,

  KALA PHARMACEUTICALS, INC.

  By:
  /s/ Eric L. Trachtenberg

  Name:
  Eric L. Trachtenberg

  Title:
  General Counsel, Chief Compliance Officer and Corporate Secretary

United States securities and exchange commission logo
March 8, 2023
Mark Iwicki
Chief Executive Officer
Kala Pharmaceuticals, Inc.
1167 Massachusetts Avenue
Arlington, MA 02476
Re:Kala Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed March 3, 2023
File No. 333-270266
Dear Mark Iwicki:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Daniel Crawford at 202-551-7767 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Scott Lunin, Esq.

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May 15, 2020

VIA EDGAR SUBMISSION

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, DC 20549

Attention:  Alan Campbell

Re:             Kala Pharmaceuticals, Inc.
 Registration Statement on Form S-3
 File No. 333-238087 Request for Acceleration

Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities Act of 1933, as amended, Kala Pharmaceuticals, Inc. (the “Company”) hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-238087), so that it may become effective at 4:00 p.m., Eastern time, on May 19, 2020, or as soon as practicable thereafter.

Very truly yours,

By:

/s/ Eric   L. Trachtenberg

Eric L.   Trachtenberg

General   Counsel, Chief Compliance Officer and Corporate Secretary

United States securities and exchange commission logo
May 13, 2020
Mark Iwicki
Chief Executive Officer
Kala Pharmaceuticals, Inc.
490 Arsenal Way, Suite 120
Watertown, MA 02472
Re:Kala Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed May 7, 2020
File No. 333-238087
Dear Mr. Iwicki:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Lia Der Marderosian, Esq.

CORRESP
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			KALA_Current_Folio_Corresp 823

			August 23, 2018

			VIA EDGAR SUBMISSION

			Securities and Exchange Commission
Division of Corporation Finance
100 F Street, NE
Washington, DC 20549

						Attention:

						Irene Paik

						Mary Beth Breslin

						Re:

						Kala Pharmaceuticals, Inc.

						Registration Statement on Form S‑3

						File No. 333‑226748

						Request for Acceleration

			Ladies and Gentlemen:

			Pursuant to Rule 461 under the Securities Act of 1933, as amended, Kala Pharmaceuticals, Inc. (the “Company”) hereby requests acceleration of the effective date of its Registration Statement on Form S‑3 (File No. 333‑226748), so that it may become effective at 3:00 p.m., Eastern time, on August 27, 2018, or as soon as practicable thereafter.

			Very truly yours,

						By:

						/s/ Eric Trachtenberg

						Eric Trachtenberg

						General Counsel, Chief Compliance Officer and Corporate Secretary

CORRESP
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			kala_Current_Folio_Corresp_20180817

						+1 617 526 6000 (t)

						+1 617 526 5000 (f)

			August 20, 2018

			Via EDGAR Submission

			Securities and Exchange Commission

			Division of Corporation Finance

			100 F Street, N.E.

			Washington, DC 20549

			Attention: Irene Paik

			      Mary Beth Breslin

				 Re:

			Kala Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed August 9, 2018
File No. 333-226748

			Ladies and Gentlemen:

			On behalf of Kala Pharmaceuticals, Inc. (the “Company”), we are providing this letter in response to the comments of the staff (the “Staff”) of the Securities and Exchange Commission’s Division of Corporate Finance contained in its letter dated August 15, 2018 (the “Comment Letter”) with respect to the above-referenced Registration Statement on Form S-3 (the “Registration Statement”).  The Company is also electronically submitting Amendment No. 1 to the Registration Statement (the “Amendment”) in response to the Comment Letter.

			Set forth below are the Company’s responses to the Staff’s comments. The responses set forth below are based upon information provided to Wilmer Cutler Pickering Hale and Dorr LLP by the Company. For convenience, the responses are keyed to the numbering of the comments and the headings used in the Comment Letter.

			On behalf of the Company, we advise you as follows:

			Registration Statement on Form S-3 filed August 9, 2018

			Cover Page

			1.We note your disclosure on the cover page and Plan of Distribution section of your sales agreement prospectus indicating that sales may be made to or through a market maker other than on an exchange or otherwise and in negotiated transactions. Please tell us whether these sales methods satisfy the "at the market" definition under Rule 415. If any sales method does not constitute a sales method that is deemed an "at the market" offering as defined in Rule 415 or if any material information with respect to a particular offering has been omitted, please confirm that you will file a prospectus supplement at the time of such sales or tell us why such additional filing would not be necessary. Please also revise these sections to state that Jefferies "will be deemed" to be an underwriter within the meaning of the Securities Act.

			Securities and Exchange Commission

			August 20, 2018

			Page 2

			Response:       In response to the Staff’s comment, the Company has revised the disclosure on the cover page and page SA-13 of the sales agreement prospectus included in the Amendment.  The Company confirms that sales made to or through a market maker other than on an exchange and sales made in negotiated transactions do not satisfy the definition of “at the market” offerings under Rule 415.  The Company further confirms that if any sales method employed does not constitute a sales method that is deemed to be an “at the market” offering, as defined in Rule 415, or if any material information with respect to a particular offering has been omitted from the sales agreement prospectus included in the Registration Statement, as amended by the Amendment, the Company will file a prospectus supplement at the time of such sale.

			General

			2.We note that you have a pending confidential treatment request for portions of Exhibit 10.1 filed in the Form 10-Q on August 9, 2018. Please be advised, we will not be in a position to accelerate the effectiveness of your registration statement until all outstanding comments on your confidential treatment request have been resolved.

			Response:        The Company acknowledges the Staff’s comment.

			If you have any further questions or comments, or if you require any additional information, please contact the undersigned by telephone at (617) 526-6982 or facsimile at (617) 526-5000. Thank you for your assistance.

			Very truly yours,

			_/s/ Lia Der Marderosian_________________

			Lia Der Marderosian

			cc:Mark Iwicki
 Eric Trachtenberg

August 15, 2018
Mark Iwicki
Chief Executive Officer
Kala Pharmaceuticals, Inc.
100 Beaver Street, Suite 201
Waltham, MA 02453
Re:Kala Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed August 9, 2018
File No. 333-226748
Dear Mr. Iwicki:
            We have limited our review of your registration statement to those issues we have
addressed in our comments.  In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.
            Please respond to this letter by amending your registration statement and providing the
requested information.  If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-3 filed August 9, 2018
Cover Page
1.We note your disclosure on the cover page and Plan of Distribution section of your sales
agreement prospectus indicating that sales may be made to or through a market maker
other than on an exchange or otherwise and in negotiated transactions. Please tell us
whether these sales methods satisfy the "at the market" definition under Rule 415. If any
sales method does not constitute a sales method that is deemed an "at the market" offering
as defined in Rule 415 or if any material information with respect to a particular offering
has been omitted, please confirm that you will file a prospectus supplement at the time of
such sales or tell us why such additional filing would not be necessary.  Please also revise

 FirstName LastNameMark Iwicki
 Comapany NameKala Pharmaceuticals, Inc.
 August 15, 2018 Page 2
 FirstName LastName
Mark Iwicki
Kala Pharmaceuticals, Inc.
August 15, 2018
Page 2
these sections to state that Jefferies "will be deemed" to be an underwriter within the
meaning of the Securities Act.
General
2.We note that you have a pending confidential treatment request for portions of Exhibit
10.1 filed in the Form 10-Q on August 9, 2018. Please be advised, we will not be in a
position to accelerate the effectiveness of your registration statement until all outstanding
comments on your confidential treatment request have been resolved.
            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
            Refer to Rules 460 and 461 regarding requests for acceleration.  Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
            Please contact Irene Paik at 202-551-6553 or Mary Beth Breslin at 202-551-3625 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc:       Lia Der Marderosian, Esq.

November 28, 2017
Mark Iwicki
Chief Executive Officer
Kala Pharmaceuticals, Inc.
100 Beaver Street, Suite 201
Waltham, MA 02453
Kala Pharmaceuticals, Inc.
Draft Registration Statement on Form S-1
Submitted November 21, 2017
CIK No. 0001479419Re:
Dear Mr. Iwicki:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            We request that you publicly file your registration statement no later than 48 hours prior to
the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for
acceleration.  We remind you that the company and its management are responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or
absence of action by the staff.
            Please contact Chris Edwards at (202) 551-6761 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Lia Der Marderosian

CORRESP
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J.P. Morgan Securities LLC

383 Madison Avenue

New York, New York 10179

Merrill Lynch, Pierce, Fenner & Smith

Incorporated

One Bryant Park

New York, NY 10036

July 17, 2017

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, D.C. 20549

Re:                             Kala Pharmaceuticals, Inc.

Registration Statement on Form S-1

Registration File No. 333-218936

Ladies and Gentlemen:

In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, the representatives of the several underwriters (the “Representatives”), hereby join in the request of Kala Pharmaceuticals, Inc. (the “Company”) for acceleration of the effective date of the above-referenced Registration Statement on Form S-1, as amended, so that it will be declared effective at 4:00 PM, Eastern Daylight Time, on July 19, 2017 or as soon thereafter as practicable, or at such other time as the Company or its outside counsel, Wilmer Cutler Pickering Hale and Dorr LLP, may orally request via telephone call that such Registration Statement be declared effective.

Pursuant to Rule 460 under the Act, we, as the Representatives, wish to advise you that approximately 3,869 copies of the Preliminary Prospectus, dated July 10, 2017 and included in the above-referenced Registration Statement, as amended, were distributed during the period from July 10, 2017 through the date hereof, to prospective underwriters, institutions, dealers and others.

We were advised on July 12, 2017 by the Corporate Financing Department of the Financial Industry Regulatory Authority that it has reviewed the above-referenced proposed offering and that it has determined to raise no objections with respect to the fairness of the terms and arrangements of the offering.

We, the undersigned, as the Representatives, each confirm on behalf of ourselves and the other participating underwriters that we will comply with the requirements of Rule 15c2-8 under

the Securities Exchange Act of 1934, as amended, in connection with the above-referenced issuance.

Very truly yours,

J.P. MORGAN   SECURITIES LLC

MERRILL LYNCH,   PIERCE, FENNER & SMITH

INCORPORATED

By:

J.P. MORGAN   SECURITIES LLC

By:

/s/ Phil Ross

Name:

Phil Ross

Title:

Managing Director

By:

MERRILL LYNCH,   PIERCE, FENNER & SMITH

INCORPORATED

By:

/s/ Michele A.H. Allong

Name:

Michele A.H.   Allong

Title:

Authorized   Signatory

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Kala Pharmaceuticals, Inc.

100 Beaver Street, Suite 201

Waltham, MA 02453

July 17, 2017

VIA EDGAR

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, DC 20549

Re:  Kala Pharmaceuticals, Inc.

Registration Statement on Form S-1

File No. 333-218936

Request for Acceleration

Ladies and Gentlemen:

Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Kala Pharmaceuticals, Inc. (the “Registrant”) hereby requests acceleration of the effective date of its Registration Statement on Form S-1 (File No. 333-218936), as amended (the “Registration Statement”), so that it may become effective at 4:00 p.m. Eastern time on July 19, 2017, or as soon thereafter as practicable.

[The remainder of this page is intentionally left blank.]

Very truly yours,

Kala   Pharmaceuticals, Inc.

By:

/s/ Mark Iwicki

Name:

Mark Iwicki

Title:

Chief Executive Officer

[Signature Page to Request for Acceleration]

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+1 617 526 6000 (t)

+1 617 526 5000 (f)

FOIA CONFIDENTIAL TREATMENT REQUEST

The entity requesting confidential treatment is:

Kala Pharmaceuticals, Inc.

100 Beaver Street

Suite 201

Waltham, MA 02453

Attn: Mark Iwicki

Chief Executive Officer

(781) 996-5252

June 28, 2017

VIA EDGAR SUBMISSION

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, DC 20549

  Attention: Suzanne Hayes

Re:

Kala   Pharmaceuticals, Inc.

Registration   Statement on Form S-1

Filed   June 23, 2017

File   No. 333-218936

Ladies and Gentlemen:

On behalf of Kala Pharmaceuticals, Inc. (the “Company”), set forth below is additional information to supplement the Company’s prior responses to comment 7 contained in the letter dated October 20, 2015 from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) relating to the Draft Registration Statement on Form S-1 (File No. 377-01157), confidentially submitted by the Company to the Commission on September 21, 2015.  Such Draft Registration Statement has been updated by the Company as reflected in the

registration statement referenced above (File No. 333-218936), which was publicly filed by the Company on June 23, 2017 (the “Registration Statement”).  The supplemental response set forth below is based upon information provided to Wilmer Cutler Pickering Hale and Dorr LLP by the Company.

Determining the Fair Value of Common Stock Prior to the IPO

As disclosed in the Registration Statement, the Company’s board of directors (the “Board”) has historically determined the fair value of its common stock on each equity grant date with input from management, considering the Company’s most recently available third-party valuations of common stock and the Company’s board of directors’ assessment of additional objective and subjective factors that it believed were relevant and which may have changed from the date of the most recent valuation through the date of the grant.  The valuations as of March 31, 2016 and March 31, 2017 that were used for equity grants were prepared using a hybrid of the option-pricing method and the probability-weighted expected return method.  These valuation analyses included judgments regarding, among other factors, the determination of an appropriate valuation method at each grant date, the estimated time to complete an initial public offering (“IPO”) or other liquidity events, the probabilities assigned to such events and the related valuations under each scenario.

The Company determined that the fair value of its common stock increased from $0.64 per share as of the valuation date of March 31, 2016 (used for the option grant date of June 17, 2016) to $0.74 per share as of the valuation date of March 31, 2017 (used for the Company’s most recent option grant date of April 24, 2017).  The primary driver of the increase in fair value over that time was an increase in the probability of an IPO (i.e., from 20% as of June 17, 2016, to 30% as of April 24, 2017).  The increase in the probability of an IPO between June 17, 2016 and April 24, 2017 was due, in part, to developments in the Company’s business, including receipt of $67.9 million in a Series C financing in April 2016, initiation of two Phase 3 clinical trials of KPI-121 0.25% for the treatment of dry eye disease in June 2016, initiation of a second, confirmatory Phase 3 trial of KPI-121 1.0% for patients with inflammation and pain following cataract surgery in June 2016 and the Company re-engaging its IPO process by confidentially submitting amendment no. 3 to its draft registration statement in March 2017.

The reason that the probability of an IPO was not higher than 30% as of April 24, 2017 was due, in part, to:

·                  the Company continuing to engage with potential strategic partners regarding a potential acquisition of the Company; and

2

·                  the fact that the Company’s Board had not yet approved the Company proceeding with the IPO.

Initial Public Offering Price Range

Rule 83 Confidential Treatment Request by Kala Pharmaceuticals, Inc. Request #1

The Company has taken into consideration guidance and market data from its underwriters that have been presented to and reviewed by the Board and management at meetings in May 2017 and June 2017.  To provide further information for the Staff’s consideration, the Company supplementally advises the Staff that the Company currently anticipates that the price range for this offering will be within the range of $*** to $*** per share (before giving effect to a reverse stock split that the Company plans to implement prior to effectiveness of the Registration Statement). This anticipated price range is based on a number of factors, including the Company’s future prospects and those of the Company’s industry in general, the Company’s financial and operating information in recent periods, the market prices of securities of companies engaged in activities similar to the Company’s, existing conditions in the public capital markets and preliminary discussions with the underwriters regarding potential valuations of the Company.  The actual price range to be included in a subsequent amendment to the Registration Statement (which will comply with the Staff’s interpretation regarding the parameters of a bona fide price range) has not yet been determined and remains subject to adjustment based on factors outside of the Company’s control.  However, the Company believes that the foregoing indicative price range will not be subject to significant change.

The anticipated price range for this offering was determined with reference to several quantitative and qualitative factors, each of which contributed to the difference between the Company’s most recent valuation of its common stock used for equity grants as of March 31, 2017 of $0.74 per share and the midpoint of the anticipated offering price range of $*** per share. Specifically, the Company believes that the difference between the fair value of its common stock determined as of March 31, 2017 and the midpoint of the anticipated offering price range for this offering is primarily the result of the following factors:

Kala Pharmaceuticals, Inc. respectfully requests that the information contained in the response be treated as confidential information and that the Commission provide timely notice to Mark Iwicki, Chief Executive Officer, Kala Pharmaceuticals, Inc., 100 Beaver Street, Suite 201, Waltham, MA 02453, (781) 996-5252, before it permits any disclosure of the double-underlined and highlighted information in Request #1.

3

·                  The estimated price range for this offering is based only upon a scenario in which the Company completes this offering and is not probability weighted, in contrast to the Company’s prior valuations of its common stock, which considered multiple potential outcomes, some of which would have resulted in a lower value of the Company’s common stock than an initial public offering.  In the March 31, 2017 valuation, the probability weighting for the IPO scenario was 30%, as described above.  If the Company had applied a weighting of 100% to the scenario of an IPO, the fair value of the Company’s common stock in the March 31, 2017 valuation would have been $1.04 per share, after applying a discount of 21% for lack of marketability.

·                  The estimated price range for this offering necessarily assumes that the Company’s IPO has occurred and a public market for the Company’s common stock has been created, and therefore excludes any discount for lack of marketability of the Company’s common stock.  In the March 31, 2017 valuation, the discount for lack of marketability that was applied to the IPO and sales scenarios was 21%.

·                  The estimated price range for this offering necessarily assumes that all of the Company’s preferred stock has converted into common stock in connection with this offering.  The Company’s preferred stock currently has substantial economic rights and preferences over the Company’s common stock.  Upon the closing of this offering, all outstanding shares of the Company’s preferred stock will convert into common stock, thus eliminating the superior rights and preferences of the preferred stock as compared to the common stock.

·                  The Company received positive results from its second, confirmatory Phase 3 trial of KPI-121 1.0% for patients with inflammation and pain following cataract surgery in April 2017.

·                  The Company successfully completed its pharmacokinetic trials of KPI-121 1.0% and KPI-121 0.25%.

·                  In recent “testing-the-waters” meetings, the Company received positive feedback from potential investors.

·                  The Company has taken additional steps towards the completion of an IPO, including:

·                  on June 22, 2017, the Board approved the Company’s certificate of incorporation, bylaws, committee charters and various governance policies that will become effective upon the closing of the IPO; and

4

·                  on June 23, 2016, the Company publicly filed the Registration Statement with the Commission.

·                  The proceeds of a successful IPO would substantially strengthen the Company’s balance sheet by increasing its cash resources.  In addition, the completion of this offering would provide the Company with more ready access to the public company equity and debt markets.

·                  In the public markets, the Company believes there are investors who may apply more qualitative and subjective valuation criteria to certain of its preclinical and clinical assets than the valuation methods applied in the Company’s valuations, although there can be no assurance that this will in fact be the case.  As a private company, the Company used a more quantitative methodology to determine the fair value of its common stock and this methodology differs from the methodology used to determine the estimated price range for this offering.  The estimated price range for this offering was not derived using a formal determination of fair value, but rather was determined by negotiation between the Company and the underwriters for the IPO.  In particular, the estimate of fair value of the Company’s common stock as of March 31, 2017 was not a factor in setting the estimated price range for this offering.

·                  The price that investors are willing to pay in this IPO, for which the price range is intended to serve as an estimate, may take into account other factors that have not been expressly considered in the Company’s prior valuations, are not objectively determinable, and that valuation models are not able to quantify.

The Company requests confidential treatment under 17 C.F.R. § 200.83 for the contents of this letter and has submitted a separate request for confidential treatment in accordance therewith to the Commission’s Office of Freedom of Information and Privacy Act Operations.

5

If you have any further questions or comments, or if you require any additional information, please contact the undersigned by telephone at (617) 526-6982. Thank you for your assistance.

Very truly yours,

/s/   Lia Der Marderosian

Lia Der Marderosian

cc:

Mark Iwicki

Dorrie Yale, U.S. Securities and Exchange Commission

Office of Freedom of Information and Privacy Act Operations

Securities and Exchange Commission

100 F Street N.E., Mail Stop 2736

Washington, D.C. 20549

6

CORRESP
1
filename1.htm

June 23, 2017

Via EDGAR Submission

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, DC 20549

Attention: Suzanne Hayes

Re:

Kala   Pharmaceuticals, Inc.

Amendment   No. 4 to Draft Registration Statement on Form S-1

Submitted   June 2, 2017

CIK   No. 0001479419

Ladies and Gentlemen:

On behalf of Kala Pharmaceuticals, Inc. (the “Company”), submitted herewith is the Registration Statement on Form S-1 (the “Registration Statement”) relating to the registration under the Securities Act of 1933, as amended, of the initial public offering of common stock of the Company.

The Registration Statement is being filed in part to respond to the comments of the staff (the “Staff”) of the Securities and Exchange Commission contained in its letter dated June 14, 2017 (the “Comment Letter”), relating to the above referenced Amendment No. 4 to the Confidential Draft Registration Statement on Form S-1.

Set forth below are the Company’s responses to the Staff’s comments. The responses set forth below are based upon information provided to Wilmer Cutler Pickering Hale and Dorr LLP by the Company. For convenience, the responses are keyed to the numbering of the comments and the headings used in the Comment Letter.

On behalf of the Company, we advise you as follows:

Prospectus Summary, page 1

Our Product Candidates, page 2

1.                                      Please provide the basis for your estimate that dry eye disease affects approximately 33 million people in the U.S.

Response:                                      In response to the Staff’s comment, the Company has revised the disclosure on page 3 of the prospectus forming part of the Registration Statement (the “Prospectus”).

Manufacturing, page 112

2.                                      We note your disclosure that one of your testing laboratories has received a Form FDA 483 containing two inspectional observations. Please revise your disclosure to describe these inspectional observations.

Response:                                      In response to the Staff’s comment, the Company has revised the disclosure on pages 26 and 113 of the Prospectus.

If you have any further questions or comments, or if you require any additional information, please contact the undersigned by telephone at (617) 526-6982 or facsimile at (617) 526-5000. Thank you for your assistance.

Very   truly yours,

/s/   Lia Der Marderosian

Lia   Der Marderosian

cc: Mark   Iwicki

2

Mail Stop 4546
June 14 , 2017

Mark Iwicki
Chief Executive Officer
Kala Pharmaceuticals, Inc.
100 Beaver Street, Suite 201
Waltham, MA 02453

Re: Kala Pharmaceuticals, Inc.
Amendment No. 4 to
Draft Registration Statement on Form S-1
Submitted June 2 , 2017
  CIK No. 0001479419

Dear Mr. Iwicki :

We have reviewed your amended draft registration statement  and have the following
comments.  In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.

Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or  publicly  filing your registration statement on
EDGAR.  If you do not believe our comments apply to your facts and circum stances or do not
believe an amendment is appropriate, please tell us why in your response.

After reviewing the information you provide in response to these  comments  and your
amended draft registration statement or filed registration statement,  we may have  additional
comments.   Unless we note otherwise, our references to prior comments are to comments in our
April 26, 2017 letter.

Prospectus Summary
Our Product Candidates, page 2

1. Please provide the basis for your estimate that dry eye disease affects approximately 33
million people in the U.S.

Manufacturing, page 112

2. We note your disclosure that one of your testing laboratories has received a Form FDA
483 containing two inspectional observations.  Please revise your disclosure to describe
these inspectional observations.

Mark Iwicki
Kala Pharmaceuticals, Inc.
June 14, 2017
Page 2

 You may contact Mark Brunhofer at (202) 551 -3638 or James Rosenberg at (202) 551 -
3679  if you have questions regarding comments on the financial statements and related matters.
Please contact Dorrie Yale at 202 -551-8776 or me at 202-551-3675  with any other questions.

Sincerely,

 /s/ Suzanne Hayes

Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance

cc: Lia Der Marderosian, Esq.
     Wilmer Cutler Pickering Hale and Dorr LLP

Mail Stop 4546
April 26, 2017

Mark Iwicki
Chief Executive Officer
Kala Pharmaceuticals, Inc.
100 Beaver Street, Suite 201
Waltham, MA 02453

Re: Kala Pharmaceuticals, Inc.
Amendment No. 3  to Draft Registration Statement on Form S-1
Submitted March 30, 2017
  CIK No. 0001479419

Dear Mr. Iwicki :

We have reviewed your amended draft registration statement  and have the following
comments.  In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.

Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or  publicly  filing your registration statement on
EDGAR.  If you do not believe our comments apply to your facts and circum stances or do not
believe an amendment is appropriate, please tell us why in your response.

After reviewing the information you provide in response to these  comments  and your
amended draft registration statement or filed registration statement,  we may have  additional
comments.

Prospectus Summary
Overview, page 1

1. At their first use, please describe the meaning of strabismus, viteoretinal and
prostaglandins.

Our Product Candidates, page 2

2. Please revise your pipeline chart on page to clearly illustra te that you are continuing to
conduct phase 3 trials related to post -operative inflammation and pain following surgery
and the temporary relief of the signs and symptoms of dry eye disease.  It is not visually
clear from the horizontal bar that you are con tinuing to conduct phase 3 trials.

Mark Iwicki
Kala Pharmaceuticals, Inc.
April 26, 2017
Page 2

 3. We refer to your statement on page 2 that KPI -121 1.0% has a “favorable safety and
tolerability” profile, your similar statement for KP -121 0.25% on page 3, and similar
disclosures elsewhere.  While we will not object to a statement that your drug candidate
was well tolerated, a safety determination is solely within the FDA’s authority.  Please
remove the statement that the study results displayed a favorable safety profile or trials
demonstrated or established safety.

4. Please limit the summary discussion of your results to whether the candidate met the
primary end points, the description of the primary endpoints and disclosure of any serious
adverse effects.  Your discussion of p values is more appropriate for the Business
discussion, where you should also discuss the meaning of these values and how they
relate to the FDA’s evidentiary standards of efficacy.

5. We refer to your statement on page 3 that if approved, KPI -121 0.25% could be the first
product providing “temporary  relief” for the signs and symptoms of dry eye disease.
However, we also note that you state that the prescription product Xiidra treats the signs
and symptoms of dry eye disease.  Please further explain why your product differs from
Xiidra, and also that  Xiidra is dosed only twice a day.

Risks Associated with Our Business, page 4

6. Please expand your disclosure in the penultimate bullet in this section to also discuss that
you are aware of a third party European patent that may limit your ability to devel op and
commercialize KPI -121 0.25% for the treatment of dry eye disease in Europe without a
license.

Business
Our Product Candidates, page 83

7. We refer to your disclosures on pages 83 and 84 regarding a clinician survey of 73
ophthalmologists and optometr ists, and a survey of 30 patients with dry eye disease
commissioned by you.  Please clarify whether the surveys were conducted by a third
party for use in the registration statement.  If they were conducted by a third party,
identify the party and file a c onsent pursuant to Rule 436 of the Securities Act.  In
addition, please provide additional details regarding the surveys so that an investor may
understand their significance, including what information regarding the product
candidates were provided to tho se surveyed, and how the surveyed clinicians and patients
were selected.  Please also provide balancing disclosure regarding the limited number of
those surveyed, and delete references to these surveys from your Summary.

Mark Iwicki
Kala Pharmaceuticals, Inc.
April 26, 2017
Page 3

 You may contact Mark Brunhofer at (202) 551 -3638 or James Rosenberg at (202) 551 -
3679  if you have questions regarding comments on the financial statements and related matters.
Please contact Dorrie Yale at 202 -551-8776 or me at 202 -551-3675  with any other questions.

Sincerely,

 /s/ Mary Beth Breslin for

Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance

cc:  Lia Der Marderosian, Esq.
      Wilmer Cutler Pickering Hale and Dorr LLP

Mail Stop 4720
October 20, 2015

Via E -mail
Mark Iwicki
Chief Executive Officer
Kala Pharmaceuticals, Inc.
100 Beaver Street, Suite 201
Waltham, MA 02453

Re: Kala Pharmaceuticals, Inc.
Draft Registration Statement on Form S -1
Submitted September 21, 2015
  CIK No. 0001479419

Dear Mr. Iwicki :

We have reviewed your draft registration statement  and have the following comments.  In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.

Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR.  If y ou do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.

After reviewing the information you provide in response to these  comments  and your
amended draft registration statement or filed registration statement,  we may have  additional
comments.

Prospectus Summary, page 1

Overview, page 1

1. Please provide a brief explanation of the Section 505(b)(2) pathway to FDA approval and
how it  differs from Section 505(b)(1) approval.

Our Product Candidates , page 2

2. Please revise your pipeline table to delete the reference to KPI -285.  Since you have not
yet selected an indication for the product candidate, it is premature to include it in a
product pipeline table.   Please make conforming changes to the pipeline table on page 82.

Mark Iwicki
Kala Pharmaceuticals, Inc.
October 20, 2015
Page 2

 3. Please revise your discussion of KPI -121 0.25% for Meibomian Gland Disease to
disclose the primary endpoints for the Phase 2 trial and that the product candidate did no t
meet one of its primary endpoints.

Risks Associated with Our Business, page 4

4. Please expand the disclosure in your first bullet point to disclose the fact that the report of
your independent registered public accounting firm  states that there is substa ntial doubt
regarding your ability to continue as a going concern.

Risk Factors, page 10
“If serious adverse or unacceptable side effects…,” page 20

5. Please disclose whether any patients in clinical studies of KPI-121 0.25% or KPI -121
1.0%  initiated to date have experienced serious adverse events related to the
administration of KPI -121 0.25% or KPI -121 1.0% .

Use of Proceeds, page 54

6. For each product candidate that you intend to develop with the proceeds from this
offering, please state t he anticipated stage of development that you expect to reach using
the proceeds of the offering.

Management’s Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Significant Judgments and Estimates
Stock-based compensation and common stock valuation, page 71

7. We may have additional comments on your accounting for equity issuances including
stock compensation and beneficial conversion features.  Once you have an estimated
offering price, please provide u s an analysis explaining the reasons for the differences
between recent valuations of your common stock leading up to the IPO and the estimated
offering price.

Business, page 81

Overview, page 81

8. Please disclose all investigational new drug applications (“INDs”) that you have
submitted to the FDA as well as the indication(s) and sponsor(s) for any active INDs
related to your product candidates.

Mark Iwicki
Kala Pharmaceuticals, Inc.
October 20, 2015
Page 3

 Our MPP Technology
MPP Technology , page 86

9. We no te your statement below the graphic on page 87 that the graphic “ is not intended to
provide an actual representation of the proportion of nanoparticles that reach the eye
surface or the way in which our MPP drug nanoparticles interact with the ocular surfa ce.”
If the graphic is not an accurate depiction of how your product candidate works, please
delete the graphic from the prospectus.

Intellectual Property, page 103

10. Please revise this section to indicate which of your material patents or patent applications
are owned by you, licensed by you or co -owned with another party.  If licensed or co -
owned, please indicate the licensor or co -owner.

License Agreements
The John Hopkins University
Financial Terms, page 105

11. We note your statement that you mu st “pay a percentage, ranging from low single digits
to low double digits, of certain consideration that [you] or [your] affiliates receive from
sublicensing rights under the licensed JHU intellectual property…”  Please revise your
description of royalty r ates to provide a range that does not exceed ten percent (e.g.
between twenty and thirty percent).

Transactions with Related Persons
Series B -1 Preferred Stock Financing, page 142

12. Please disclose the consideration received from the sale of your Series B -1 preferred
stock.

General

13. Please confirm that the images included in your draft registration statement are all of the
graphic, visual or photographic information you will be including. If you intend to use
any additional images, please provide us proofs  of such materials. Please note that we
may have comments regarding this material.

14. Please supplementally provide us with copies of all written communications, as defined
in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your
behalf, present to potential investors in reliance on Section 5(d) of the Securities Act,
whether or not they retain copies of the communications.

Mark Iwicki
Kala Pharmaceuticals, Inc.
October 20, 2015
Page 4

 You may contact Mark Brunhofer  at (202) 551 -3638  or James Rosenberg  at (202) 551 -
3679  if you have questions  regarding comments on the financial statements and related matters.
Please contact Christina De Rosa  at (202) 551 -3577 or me at (202) 551 -3675  with any other
questions.

Sincerely,

 /s/ Suzanne Hayes

 Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
cc: Via E -mail
 Lia Der Marderosian, Esq.
 Wilmer Cutler Pickering Hale and Dorr LLP
 60 State Street
 Boston, Massachusetts 02109