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SpyGlass Pharma, Inc.
CIK: 0001778922  ·  File(s): 333-292779, 377-08508  ·  Started: 2026-01-27  ·  Last active: 2026-01-29
Response Received 3 company response(s) High - file number match
UL SEC wrote to company 2026-01-27
SpyGlass Pharma, Inc.
Related Party / Governance Regulatory Compliance Financial Reporting
File Nos in letter: 333-292779
↓
CR Company responded 2026-01-29
SpyGlass Pharma, Inc.
Regulatory Compliance Related Party / Governance Financial Reporting
References: January 27, 2026
↓
CR Company responded 2026-01-29
SpyGlass Pharma, Inc.
Offering / Registration Process Regulatory Compliance Financial Reporting
File Nos in letter: 333-292779
↓
CR Company responded 2026-01-29
SpyGlass Pharma, Inc.
Offering / Registration Process Regulatory Compliance Financial Reporting
File Nos in letter: 333-292779
SpyGlass Pharma, Inc.
CIK: 0001778922  ·  File(s): 377-08508  ·  Started: 2026-01-13  ·  Last active: 2026-01-16
Response Received 1 company response(s) Medium - date proximity
UL SEC wrote to company 2026-01-13
SpyGlass Pharma, Inc.
Financial Reporting Regulatory Compliance Business Model Clarity
↓
CR Company responded 2026-01-16
SpyGlass Pharma, Inc.
Regulatory Compliance Financial Reporting Business Model Clarity
References: January 13, 2026
SpyGlass Pharma, Inc.
CIK: 0001778922  ·  File(s): 377-08508  ·  Started: 2025-12-01  ·  Last active: 2025-12-01
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2025-12-01
SpyGlass Pharma, Inc.
Regulatory Compliance Financial Reporting Risk Disclosure
DateTypeCompanyLocationFile NoLink
2026-01-29 Company Response SpyGlass Pharma, Inc. DE N/A
Regulatory Compliance Related Party / Governance Financial Reporting
Read Filing View
2026-01-29 Company Response SpyGlass Pharma, Inc. DE N/A
Offering / Registration Process Regulatory Compliance Financial Reporting
Read Filing View
2026-01-29 Company Response SpyGlass Pharma, Inc. DE N/A
Offering / Registration Process Regulatory Compliance Financial Reporting
Read Filing View
2026-01-27 SEC Comment Letter SpyGlass Pharma, Inc. DE 377-08508
Related Party / Governance Regulatory Compliance Financial Reporting
Read Filing View
2026-01-16 Company Response SpyGlass Pharma, Inc. DE N/A
Regulatory Compliance Financial Reporting Business Model Clarity
Read Filing View
2026-01-13 SEC Comment Letter SpyGlass Pharma, Inc. DE 377-08508
Financial Reporting Regulatory Compliance Business Model Clarity
Read Filing View
2025-12-01 SEC Comment Letter SpyGlass Pharma, Inc. DE 377-08508
Regulatory Compliance Financial Reporting Risk Disclosure
Read Filing View
DateTypeCompanyLocationFile NoLink
2026-01-27 SEC Comment Letter SpyGlass Pharma, Inc. DE 377-08508
Related Party / Governance Regulatory Compliance Financial Reporting
Read Filing View
2026-01-13 SEC Comment Letter SpyGlass Pharma, Inc. DE 377-08508
Financial Reporting Regulatory Compliance Business Model Clarity
Read Filing View
2025-12-01 SEC Comment Letter SpyGlass Pharma, Inc. DE 377-08508
Regulatory Compliance Financial Reporting Risk Disclosure
Read Filing View
DateTypeCompanyLocationFile NoLink
2026-01-29 Company Response SpyGlass Pharma, Inc. DE N/A
Regulatory Compliance Related Party / Governance Financial Reporting
Read Filing View
2026-01-29 Company Response SpyGlass Pharma, Inc. DE N/A
Offering / Registration Process Regulatory Compliance Financial Reporting
Read Filing View
2026-01-29 Company Response SpyGlass Pharma, Inc. DE N/A
Offering / Registration Process Regulatory Compliance Financial Reporting
Read Filing View
2026-01-16 Company Response SpyGlass Pharma, Inc. DE N/A
Regulatory Compliance Financial Reporting Business Model Clarity
Read Filing View
2026-01-29 - CORRESP - SpyGlass Pharma, Inc.
Read Filing Source Filing Referenced dates: January 27, 2026
CORRESP
 1
 filename1.htm

 Document Wilson Sonsini Goodrich & Rosati Professional Corporation 12235 El Camino Real San Diego, California 92130-3002 O: 858.350.2300 F: 858.350.2399 January 29, 2026 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Industrial Applications and Services 100 F Street, N.E. Washington, D.C. 20549 Attention: Robert Augustin Margaret Sawicki Christie Wong Li Xiao Re: SpyGlass Pharma, Inc. Registration Statement on Form S-1 Filed January 16, 2026 CIK No. 0001778922 Ladies and Gentlemen: On behalf of our client, SpyGlass Pharma, Inc. (“ SpyGlass ” or the “ Company ”), we submit this letter in response to comments from the staff (the “ Staff ”) of the U.S. Securities and Exchange Commission received by letter dated January 27, 2026, concerning the above referenced registration statement on Form S-1 (the “ Registration Statement ”). In response to the Staff’s comments, the Company has revised the Registration Statement and is concurrently filing via EDGAR this letter and an Amendment No. 1 to the Registration Statement on Form S-1 (the “ Amendment ”). In this letter, we have recited the comment from the Staff in italicized, bold type and have followed the comment with the Company’s response. Registration Statement on Form S-1 Exhibits 1. We note Article 9.5 of your Form of Amended and Restated Bylaws to be in effect upon completion of the offering, filed as Exhibit 3.4, does not expressly address claims arising under the Exchange Act. It applies to derivative actions and provides the federal district court for the District of Delaware as the exclusive forum if the Court of Chancery of the State of Delaware does not have jurisdiction. We note your disclosure on pages 73 and 187 says "[t]his provision would not apply to any action brought to enforce a duty or liability created by the Exchange Act and the rules and regulations thereunder." Please revise to reconcile your disclosure with your Bylaws, or advise. AUSTIN     BEIJING     BOSTON     BOULDER     BRUSSELS     HONG KONG     LONDON     LOS ANGELES     NEW YORK     PALO ALTO SALT LAKE CITY     SAN DIEGO     SAN FRANCISCO     SEATTLE     WASHINGTON, DC     WILMINGTON, DE Securities and Exchange Commission January 29, 2026 Page 2 The Company respectfully acknowledges the Staff’s comment and has revised Article 9.5 of the Form of Amended and Restated Bylaws to be in effect upon completion of the offering and filed such revised version as Exhibit 3.4. ***** If the Staff has any questions or comments concerning the foregoing, or requires any further information, please contact me at (858) 350-2393 or dkoeppen@wsgr.com. Sincerely, WILSON SONSINI GOODRICH & ROSATI Professional Corporation /s/ Dan Koeppen Dan Koeppen cc: Patrick Mooney, SpyGlass Pharma, Inc. Jennifer Fang, Wilson Sonsini Goodrich & Rosati, P.C. Robert L. Wernli, Jr., Wilson Sonsini Goodrich & Rosati, P.C. Ben Capps, Wilson Sonsini Goodrich & Rosati, P.C. B. Shayne Kennedy, Latham & Watkins LLP J. Ross McAloon, Latham & Watkins LLP
2026-01-29 - CORRESP - SpyGlass Pharma, Inc.
CORRESP
 1
 filename1.htm

 Document January 29, 2026 Jefferies LLC 520 Madison Avenue New York, New York 10022 Leerink Partners LLC 1301 Avenue of the Americas, 5th Floor New York, NY 10019 Citigroup Global Markets Inc. 388 Greenwich Street New York, NY 10013 Stifel, Nicolaus & Company, Incorporated 787 7th Avenue, 11th Floor New York, NY 10019 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn:                    Robert Augustin Margaret Sawicki Christie Wong Li Xiao Re:        SpyGlass Pharma, Inc. Registration Statement on Form S-1 (File No. 333-292779) Acceleration Request Requested Date: January 30, 2026 Requested Time: 4:05 p.m. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 of the Securities Act of 1933, as amended (the “ Securities Act ”), we, as representatives of the several underwriters (the “ Representatives ”), hereby join in the request of SpyGlass Pharma, Inc., a Delaware corporation (the “ Registrant ”), that the effectiveness of the above-captioned Registration Statement, as amended, be accelerated to 4:05 p.m. Eastern Time on January 30, 2026, or as soon thereafter as practicable, or at such other time as the Registrant or its outside counsel, Wilson Sonsini Goodrich & Rosati, P.C., request by telephone that such Registration Statement be declared effective. Pursuant to Rule 460 under the Securities Act, please be advised that we will take reasonable steps to secure adequate distribution of the preliminary prospectus, to underwriters, dealers, institutions and others, prior to the requested effective time of the Registration Statement. We, the undersigned Representatives, have and will, and we have been informed by the participating underwriters that they have and will, comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended, in connection with the proposed offering. [Remainder of page intentionally left blank] Very truly yours, Acting severally on behalf of themselves and the several underwriters JEFFERIES LLC LEERINK PARTNERS LLC CITIGROUP GLOBAL MARKETS INC. STIFEL, NICOLAUS & COMPANY, INCORPORATED JEFFERIES LLC By: /s/ Kevin Lacerda Name: Kevin Lacerda Title: Managing Director LEERINK PARTNERS LLC By: /s/ Andrew Gitkin Name: Andrew Gitkin Title: Senior Managing Director CITIGROUP GLOBAL MARKETS INC. By: /s/ Jason Jun Name: Jason Jun Title: Managing Director STIFEL, NICOLAUS & COMPANY, INCORPORATED By: /s/ Nick Oust Name: Nick Oust Title: Managing Director [ Signature Page to Underwriters’ Acceleration Request Letter ]
2026-01-29 - CORRESP - SpyGlass Pharma, Inc.
CORRESP
 1
 filename1.htm

 Document January 29, 2026 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Industrial Applications and Services 100 F Street, N.E. Washington, D.C. 20549 Attention:    Robert Augustin Margaret Sawicki Christie Wong Li Xiao Re:               SpyGlass Pharma, Inc. Registration Statement on Form S-1 (File No. 333-292779) Acceleration Request Requested Date: January 30, 2026 Requested Time: 4:05 P.M. Eastern Time Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “ Securities Act ”), SpyGlass Pharma, Inc. (the “ Company ”) hereby requests that the above-referenced Registration Statement on Form S-1 (File No. 333-292779)  (the “ Registration Statement ”) be declared effective at the “Requested Date” and “Requested Time” set forth above, or as soon thereafter as practicable, or at such later time as the Company or its counsel may orally request via telephone call to the staff (the “ Staff ”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “ Commission ”). Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Wilson Sonsini Goodrich & Rosati, P.C., by calling Ben Capps at (858) 350-2237. The Company understands that the Staff will consider this request as confirmation by the Company of its awareness of its responsibilities under the federal securities laws as they relate to the offering of the securities covered by the Registration Statement. Further, the Company confirms that it and its managing or principal underwriters are aware of their obligations under the Securities Act, including Section 6(e)(1) thereof, and hereby confirm that the Company will not conduct a road show, as defined in Rule 433(h)(4), until at least 15 days after the Company publicly filed its initial confidential submission and all amendments thereto. [ Signature page follows ] Sincerely, SPYGLASS PHARMA, INC. /s/ Patrick Mooney Patrick Mooney Chief Executive Officer cc:        Dan Koeppen, Wilson Sonsini Goodrich & Rosati, P.C. Jennifer Fang, Wilson Sonsini Goodrich & Rosati, P.C. Robert L. Wernli, Jr., Wilson Sonsini Goodrich & Rosati, P.C. Ben Capps, Wilson Sonsini Goodrich & Rosati, P.C. B. Shayne Kennedy, Latham & Watkins LLP J. Ross McAloon, Latham & Watkins LLP
2026-01-27 - UPLOAD - SpyGlass Pharma, Inc. File: 377-08508
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 January 27, 2026

Patrick Mooney
Chief Executive Officer
SpyGlass Pharma, Inc.
27061 Aliso Creek Rd.
Suite 100
Aliso Viejo, CA 92656

 Re: SpyGlass Pharma, Inc.
 Registration Statement on Form S-1
 Filed January 16, 2026
 File No. 333-292779
Dear Patrick Mooney:

 We have reviewed your registration statement and have the following
comment.

 Please respond to this letter by amending your registration statement
and providing the
requested information. If you do not believe a comment applies 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 this letter, we may have additional comments.

Registration Statement on Form S-1
Exhibits

1. We note Article 9.5 of your Form of Amended and Restated Bylaws to be in
effect upon
 completion of the offering, filed as Exhibit 3.4, does not expressly
address claims arising
 under the Exchange Act. It applies to derivative actions and provides
the federal district
 court for the District of Delaware as the exclusive forum if the Court
of Chancery of the
 State of Delaware does not have jurisdiction. We note your disclosure on
pages 73 and
 187 says "[t]his provision would not apply to any action brought to
enforce a duty or
 liability created by the Exchange Act and the rules and regulations
thereunder." Please
 revise to reconcile your disclosure with your Bylaws, or advise.
 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.
 January 27, 2026
Page 2

 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 Christie Wong at 202-551-3684 or Li Xiao at 202-551-4391
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Robert Augustin at 202-551-8483 or Margaret Sawicki at 202-551-7153 with any
other
questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Industrial
Applications and
 Services
cc: Ben Capps, Esq.
</TEXT>
</DOCUMENT>
2026-01-16 - CORRESP - SpyGlass Pharma, Inc.
Read Filing Source Filing Referenced dates: January 13, 2026
CORRESP
 1
 filename1.htm

 Document Wilson Sonsini Goodrich & Rosati Professional Corporation 12235 El Camino Real San Diego, California 92130-3002 O: 858.350.2300 F: 858.350.2399 January 16, 2026 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Industrial Applications and Services 100 F Street, N.E. Washington, D.C. 20549 Attention: Robert Augustin Margaret Sawicki Christie Wong Li Xiao Re: SpyGlass Pharma, Inc. Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted December 10, 2025 CIK No. 0001778922 Ladies and Gentlemen: On behalf of our client, SpyGlass Pharma, Inc. (“ SpyGlass ” or the “ Company ”), we submit this letter in response to comments from the staff (the “ Staff ”) of the U.S. Securities and Exchange Commission received by letter dated January 13, 2026, concerning the above referenced draft registration statement on Form S-1 (the “ Draft Registration Statement ”). In response to the Staff’s comments, the Company has revised the Draft Registration Statement and is concurrently filing via EDGAR this letter and a Registration Statement on Form S-1 (the “ Registration Statement ”). In this letter, we have recited the comments from the Staff in italicized, bold type and have followed each comment with the Company’s response. Except for page references appearing in the headings and Staff comments below (which are references to the Draft Registration Statement), all page references herein correspond to the Registration Statement. Amendment No. 1 to Draft Registration Statement on Form S-1 Prospectus Summary, page 1 1. We note your response to comment 1 and reissue it in part. Please revise to provide appropriate sources for relevant statements throughout the filing, or characterize the same as management's opinions or beliefs, where appropriate. As an example only, please provide sources for the below statements: • " . . . approximately 45% of patients taking topical bimatoprost drops reported conjunctival hyperemia as a side effect of treatment, based on third party data;" AUSTIN     BEIJING     BOSTON     BOULDER     BRUSSELS     HONG KONG     LONDON     LOS ANGELES     NEW YORK     PALO ALTO SALT LAKE CITY     SAN DIEGO     SAN FRANCISCO     SEATTLE     WASHINGTON, DC     WILMINGTON, DE Securities and Exchange Commission January 16, 2026 Page 2 • " . . . cataract surgery [is] one of the most frequently performed outpatient procedures in ambulatory surgery centers (ASCs) in the United States . . . . We estimate that the total addressable market in the United States for the BIM-IOL System is approximately $13 billion based on . . . existing implant pricing for treatment of OAG and OHT;" • "Even when patients describe taking their glaucoma drops as prescribed, studies have shown that less than 5% of the administered dose penetrates the eye and reaches the target tissue;" and • "We estimate that a limited number of cataract surgeons and ASCs perform approximately half of all cataract surgery procedures performed in the United States each year." For the third bullet, please revise to name the devices you are using to support your implant pricing. Tell us the reason for referencing existing implant pricing when elsewhere you state that you anticipate that use of the BIM-IOL System, a "drug-led, drug-device combination product," "will . . . leverage an existing Category I Current Procedural Terminology (CPT) codes for the cataract surgery and a new J-code for the physician-administered drug" and "no separate marketing application for the device components of such [combination] product candidates will be required in the United States." Revise as necessary to clarify. In response to the Staff’s comments, the Company has revised the disclosures on pages 2, 3, 90, 104, 105, 106, 111, 112, 113, 114, 115, 116, 117, 126 and 127 to provide sources for additional statements that are based on third party data, clarify statements based on management projections and internal estimates and naming the device the Company is referencing in estimating the Company’s expected total addressable market in the United States. Importantly, the Company respectfully advises the Staff that the Company has not made any determinations nor disclosed any proposed implant pricing for the BIM-IOL System. Rather, the reference to existing implant pricing was intended to refer to the wholesale acquisition cost for iDose TR, a more recently approved and currently marketed implant (also a drug-led, drug-device combination product), which the Company is using as a reference price for supporting the Company’s calculation of the total addressable market in the United States for the BIM-IOL System. Although the Company discloses on page 127 that Durysta and iDose TR have assigned J-codes that are currently reimbursed at a price based on average sales price plus a fixed percentage, the Company has not disclosed nor determined any intended sale price for the BIM-IOL System. On the same page, the Company discloses that if and when the Company obtains marketing authorization for the BIM-IOL System, the Company expects to apply for a permanent J-code, which is a billing code for physician administered drugs, like the iDose TR and BIM-IOL System. The Company also anticipates that physicians and surgeons will be able to leverage existing CPT codes relating to the cataract surgery, which will be the billing mechanism for the surgery itself. With regards to the marketing application, both the Bimatoprost Drug Pads and the IOL that make up the BIM-IOL System are expected to be covered by a single New Drug Application (NDA). Securities and Exchange Commission January 16, 2026 Page 3 Exhibits 2. Please tell us why you deleted the Board Offer Letters with Elizabeth O’Farrell and Bilal Khan from the Exhibit Index. We note the O’Farrell Agreement is described on page 155. In response to the Staff’s comment, the Company has revised the disclosure on page 156 and has revised the exhibit index to include the board offer letters entered into with each of Elizabeth O’Farrell and Bilal Khan. ***** If the Staff has any questions or comments concerning the foregoing, or requires any further information, please contact me at (858) 350-2393 or dkoeppen@wsgr.com. Sincerely, WILSON SONSINI GOODRICH & ROSATI Professional Corporation /s/ Dan Koeppen Dan Koeppen cc: Patrick Mooney, SpyGlass Pharma, Inc. Jennifer Fang, Wilson Sonsini Goodrich & Rosati, P.C. Robert L. Wernli, Jr., Wilson Sonsini Goodrich & Rosati, P.C. Ben Capps, Wilson Sonsini Goodrich & Rosati, P.C. B. Shayne Kennedy, Latham & Watkins LLP J. Ross McAloon, Latham & Watkins LLP
2026-01-13 - UPLOAD - SpyGlass Pharma, Inc. File: 377-08508
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 January 13, 2026

Patrick Mooney
Chief Executive Officer
SpyGlass Pharma, Inc.
27061 Aliso Creek Rd.
Suite 100
Aliso Viejo, CA 92656

 Re: SpyGlass Pharma, Inc.
 Amendment No. 1 to Draft Registration Statement on Form S-1
 Submitted December 10, 2025
 CIK No. 0001778922
Dear Patrick Mooney:

 We have reviewed your amended registration statement and have the
following
comments.

 Please respond to this letter by amending your registration statement
and providing
the requested information. If you do not believe a comment applies 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 this letter, we may have additional comments. Unless
we note
otherwise, any references to prior comments are to comments in our December 1,
2025 letter.

Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus Summary, page 1

1. We note your response to comment 1 and reissue it in part. Please revise
to provide
 appropriate sources for relevant statements throughout the filing, or
characterize the
 same as management's opinions or beliefs, where appropriate. As an
example only,
 please provide sources for the below statements:
 " . . . approximately 45% of patients taking topical bimatoprost
drops reported
 conjunctival hyperemia as a side effect of treatment, based on third
party data;"
 " . . . cataract surgery [is] one of the most frequently performed
outpatient
 procedures in ambulatory surgery centers (ASCs) in the United States
. . . . We
 estimate that the total addressable market in the United States for
the BIM-IOL
 January 13, 2026
Page 2

 System is approximately $13 billion based on . . . existing implant
pricing for
 treatment of OAG and OHT;"
 "Even when patients describe taking their glaucoma drops as
prescribed, studies
 have shown that less than 5% of the administered dose penetrates the
eye and
 reaches the target tissue;" and
 "We estimate that a limited number of cataract surgeons and ASCs
perform
 approximately half of all cataract surgery procedures performed in
the United
 States each year."

 For the third bullet, please revise to name the devices you are using to
support your
 implant pricing. Tell us the reason for referencing existing implant
pricing when
 elsewhere you state that you anticipate that use of the BIM-IOL System,
a "drug-led,
 drug-device combination product," "will . . . leverage an existing
Category I Current
 Procedural Terminology (CPT) codes for the cataract surgery and a new
J-code for the
 physician-administered drug" and "no separate marketing application for
the device
 components of such [combination] product candidates will be required in
the United
 States." Revise as necessary to clarify.
Exhibits

2. Please tell us why you deleted the Board Offer Letters with Elizabeth O
 Farrell
 and Bilal Khan from the Exhibit Index. We note the O Farrell Agreement
is described
 on page 155.
 Please contact Christie Wong at 202-551-3684 or Li Xiao at 202-551-4391
if you
have questions regarding comments on the financial statements and related
matters. Please
contact Robert Augustin at 202-551-8483 or Margaret Sawicki at 202-551-7153
with any
other questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Industrial
Applications and
 Services
cc: Ben Capps, Esq.
</TEXT>
</DOCUMENT>
2025-12-01 - UPLOAD - SpyGlass Pharma, Inc. File: 377-08508
December 1, 2025
Patrick Mooney
Chief Executive Officer
SpyGlass Pharma, Inc.
27061 Aliso Creek Rd.
Suite 100
Aliso Viejo, CA 92656
Re:SpyGlass Pharma, Inc.
Draft Registration Statement on Form S-1
Submitted September 26, 2025
CIK No. 0001778922
Dear Patrick Mooney:
            We have reviewed your draft registration statement and have the following comments.
            Please respond to this letter by providing the requested information and either
submitting an amended draft registration statement or publicly filing your registration
statement and non-public draft submissions on EDGAR. If you do not believe a comment
applies 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 this letter and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1 Submitted September 26, 2025
Prospectus Summary
Overview, page 1
Here, and throughout your filing, including your description of your business and the
market in which you intend to operate, when referring to a statistic that is not common
knowledge or a research article please cite the source and, at first instance, provide a
summary of the material findings as appropriate. For example only, you disclose that
there are 10,000 active cataract surgeons in the United States. Please make
conforming changes throughout your filing. Please provide appropriate sources for
these and other, relevant statements throughout the filing, or characterize the same as
management's opinions or beliefs, where appropriate. Please also revise to define 1.

December 1, 2025
Page 2
scientific terms such as pseudophakic, non-bioerodible, monofocal IOLs and
toric IOLs, presbyopia and SLT.
2.We note your disclosure here and throughout the filing that "[you] initiated
two registrational Phase 3 trials in July 2025, each expected to enroll approximately
400 patients across 45 sites. [You] expect to complete enrollment in [_] and, pending
successful Phase 3 results, [you] plan to submit a 505(b)(2) New Drug Application
(NDA) to the FDA in [_]." When discussing FDA or other regulatory approvals,
please revise to include a statement acknowledging that FDA or other regulatory
agency, foreign or domestic, approval is not guaranteed and may take longer than
planned. Further, when discussing trials, please revise to state that there is no
guarantee that the trials will produce positive results or that the results will support the
Company's claims. Make conforming changes throughout your filing.
3.We note that you believe that your product candidate "will be regulated by the FDA as
a drug-led, drug-device combination product" and that you plan to "pursue a
streamlined regulatory approval process under the FDA’s 505(b)(2) pathway." Please
revise your Prospectus Summary to further explain the regulatory framework for your
product candidate and the process for seeking approval under the 505(b)(2) pathway
and how it differs from other pathways, such as the 505(b)(1) pathway, and whether
the FDA may disagree with your characterization or approval pathway.
4.We note your statement on page 1: "the BIM-IOL System was observed to have a
favorable safety profile" and the headers on page 3: "Lead Product Candidate with
Long-Term Safety and Efficacy Data" and page 109: "Ultra-Low Dose and
Compelling Safety Profile May Improve Quality of Life." Conclusions regarding
safety or efficacy are solely within the authority of the FDA and comparable
regulatory bodies. As such, please remove or revise these statements and make
conforming changes throughout your filing where you discuss the safety and efficacy
of your product candidates.
5.We note your disclosure on page 1 that the Bimatoprost Drug Pad-IOL System is
designed to be implanted during routine cataract surgery to reduce elevated
intraocular pressure in patients who have either open-angle glaucoma (OAG) or
ocular hypertension (OHT). We also note your disclosure on page 2 that "[you]
estimate that the total addressable market in the United States for the BIM-IOL
System is approximately $13 billion based on the estimated one million glaucoma and
OHT patients expected to undergo cataract surgery in 2025." Please revise your
disclosure to provide the total addressable market in the United States for your
product as it relates to patients with OHT and OAG specifically, not all types of
glaucoma.
6.We note your statement on page 2 and elsewhere that your product candidate aims to
deliver a "first-in-class" solution. Given the current stage of development for this
product candidate and the length of the drug development process, such
characterization appears to be inapplicable or premature. Accordingly, please remove
the statement or otherwise advise.

December 1, 2025
Page 3
Our Strategy
Rapidly Advance Our Lead Product Candidate Through Clinical Development for
Registration, page 4
7.We note your disclosure that "Based on [y]our clinical data generated and regulatory
feedback to date, [you] initiated two registrational Phase 3 clinical trials in July 2025
to evaluate [y]our lead product candidate, the BIM-IOL System." Please revise your
disclosure to provide a summary of the regulatory feedback received.
8.Please revise this header on page 4 to avoid any implication that you have the ability
to accelerate FDA approvals and commercialization of your product candidate.
Risk Factors
We rely, and expect to continue to rely, on third parties, including independent clinical
investigators and CROs..., page 60
9.We note your disclosure that you "have relied upon and plan to continue to rely upon
third parties, including independent clinical investigators and third-party CROs, to
conduct certain aspects of [y]our preclinical studies and clinical trials and to monitor
and manage data for [y]our ongoing preclinical and clinical programs" and "if any of
[y]our relationships with these third-party CROs terminate, [you] may not be able to
enter into arrangements with alternative CROs or to do so on commercially reasonable
terms." Please expand your disclosure to identify any CROs you are substantially
dependent on and include a summary of the material terms of the relevant agreements.
To the extent you are substantially dependent on any CROs, please also file the
agreements as exhibits to the registration statement, or tell us why you believe you are
not required to do so. Refer to Item 601(b)(10) of Regulation S-K.
Use of Proceeds, page 83
10.We note your disclosure that the remainder of your net proceeds from this offering
will be used "for [y]our other research and development activities, as well as for
working capital and other general corporate purposes." Please revise your disclosure
to clarify the "other research and development activities" to which you refer.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations - Research and Development Expenses. , page 93
11.Considering research and development to be your primary operation, please tell us
your consideration of providing further breakdown of your research and development
expenses, including but not limited to, by clinical trials, and/or by nature of the
expenses.
Business
Our Solution - The SpyGlass Platform
The BIM-IOL System, Our Lead Product Candidate
Preclinical Studies, page 116
With respect to your preclinical trial disclosure, please provide the number of
subjects. We also note disclosure that in both preclinical studies "a number of
expected procedure-related microscopic or ophthalmic findings typically associated 12.

December 1, 2025
Page 4
with cataract surgery and IOL implantation were observed across all groups." Please
revise to further describe these findings. Finally, we note your disclosure that "the
dose level for bimatoprost at which there were no observed AEs was determined to be
300 mcg/eye/dose (1000 ng/eye/day in vitro)." Please revise to disclose any severe
AEs observed at higher doses.
First-in-Human Clinical Trial, page 116
13.Please revise to disclose the location of your first-in-human trial. We note that it was
outside of the U.S.
Phase 1/2 Clinical Trial, page 118
14.We note your statement on pages 120-121 that there was one severe AE reported in
the 39 mcg dose group and was related to dry eye. Please revise to more specifically
describe this severe AE.
Competition, page 125
15.We note your disclosure that you compete with alternative glaucoma surgical devices
and ophthalmic laser companies. Please revise to discuss, where appropriate, how you
distinguish yourself from these competitors.
Intellectual Property, page 125
16.In this section you state that you "co-own patents and patent applications in [y]our
intellectual property portfolio with a co-Applicant" and you "exclusively license the
co-Applicant’s rights in these patents and patent applications that are co-owned." We
note you also include tabular disclosure of co-owned and licensed patents. However,
we note statements like the following elsewhere: "[c]ompetitors may challenge,
infringe or otherwise violate our patents or our co-owned and licensed patents" and
"[a]ll Licensed Patents are either solely owned by CU or jointly owned by CU and
us." Please revise here and throughout, including the Prospectus Summary, where you
state that you "own and have in-licensed issued patents protecting [y]our pipeline
assets," to clarify whether you wholly own any patents or solely co-own and license
patents. In doing so, clarify also if you co-own all patents licensed from CU or if some
patents licensed from CU are wholly owned by CU. Finally, revise the disclosure here
to specify which patents you wholly own (as applicable), co-own, license as co-
owner, and license from CU as the sole owner (as applicable). Separately, please also
disclose the patent type for the wholly-owned patents (as applicable) and pending
patent applications as you do for your other patents in the table on pages 126-129.
Executive Compensation, page 155
We note your disclosure on page 158: "We entered into a services agreement with CU
Medicine in 2019 providing for the services of Dr. Kahook, which was amended most
recently on March 1, 2025 (the Kahook Agreement). Pursuant to the terms of the
Kahook Agreement, Dr. Kahook, who is an employee of the University of Colorado
School of Medicine, provides the Company with services and in exchange we pay CU
Medicine monthly fees for such services ($24,995 per month, as of March 1, 2025).
The Kahook Agreement may be terminated by the Company or CU Medicine at any 17.

December 1, 2025
Page 5
time upon 30 days advance written notice and is scheduled to expire on February 28,
2026 unless extended by the mutual consent of the Company and CU Medicine." We
note that Dr. Kahook is not your employee but serves as President, Chief Medical
Officer and Executive Chair. Please revise to further specify the services Dr. Kahook
provides aside from serving in these roles, if any, and whether there has been any
discussion of extending the services agreement after February 2026. Consider whether
risk factor disclosure concerning the loss of Dr. Kahook's services may be appropriate.
Exhibits
18.Please tell us what consideration you gave to filing your lease as an exhibit. Refer to
Item 601(b)(10)(ii)(D) of Regulation S-K.
General
19.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.
            Please contact Christie Wong at 202-551-3684 or Li Xiao at 202-551-4391 if you
have questions regarding comments on the financial statements and related matters. Please
contact Robert Augustin at 202-551-8483 or Margaret Sawicki at 202-551-7153 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Industrial Applications and
Services
cc:Ben Capps, Esq.

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