SecProbe.io

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.