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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 27, 2025

 

 

EyePoint Pharmaceuticals, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

000-51122

26-2774444

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

480 Pleasant Street

 

Watertown, Massachusetts

 

02472

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (617) 926-5000

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.001

 

EYPT

 

The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 


Item 8.01 Other Events.

On May 27, 2025, EyePoint Pharmaceuticals, Inc. (the “Company”) issued a press release announcing it has completed

enrollment in the pivotal Phase 3 LUGANO clinical trial evaluating DURAVYU™, an investigational sustained delivery therapy delivering patent-protected vorolanib, a selective tyrosine kinase inhibitor, for the treatment of wet age-related macular degeneration ("wet AMD"). A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.

On the same date, the Company posted an updated investor presentation on its website at www.eyepointpharma.com. A copy of

the presentation is filed herewith as Exhibit 99.2 and is incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.

 

Description

 

99.1

 

Press Release of EyePoint Pharmaceuticals, Inc. dated May 27, 2025

99.2

 

Investor Presentation of EyePoint Pharmaceuticals, Inc. dated May 27, 2025

104

 

Cover Page Interactive Data File (embedded within the inline XBRL document)

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

EYEPOINT PHARMACEUTICALS, INC.

 

 

 

 

Date:

May 27, 2025

By:

/s/ George O. Elston

 

 

 

George O. Elston
Executive Vice President and Chief Financial Officer

 


EX-99.1 2 eypt-ex99_1.htm EX-99.1 EX-99.1

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Exhibit 99.1

EyePoint Completes Enrollment in the Pivotal Phase 3 LUGANO Trial of DURAVYUTM for the Treatment of Wet Age-Related Macular Degeneration

Over 400 patients have been enrolled and randomized over a seven-month period, driven by strong physician and patient interest –

 

LUCIA pivotal Phase 3 trial continues rapid enrollment pace with 60% of patients randomized; enrollment completion expected in 3Q 2025 –

 

Topline 56-week data for LUGANO expected in mid-2026 with LUCIA to follow –

 

WATERTOWN, Mass., May 27, 2025 (GLOBE NEWSWIRE) – EyePoint Pharmaceuticals, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced it has enrolled and randomized over 400 patients in the Phase 3 LUGANO pivotal trial of DURAVYUTM for the treatment of wet age-related macular degeneration (wet AMD) exceeding its enrollment target. The seven-month enrollment for LUGANO represents one of the fastest enrolling Phase 3 pivotal trials for wet AMD to date.

LUGANO is the first of two pivotal non-inferiority trials underway in the Phase 3 program of DURAVYU for the treatment of wet AMD. Supported by the robust DAVIO 2 Phase 2 clinical trial in over 160 patients, the Phase 3 pivotal program was developed in direct alignment with the U.S. Food and Drug Administration (FDA), follows recognized industry best practices, and is strategically designed to enhance the potential for regulatory and commercial success. All patients are randomized on Day 1 and immediately begin treatment with a one-year efficacy and safety endpoint. With the completion of enrollment for LUGANO, topline data is anticipated in mid-2026.

“The rapid enrollment of the Phase 3 LUGANO trial is a testament to the significant patient and physician enthusiasm for our Phase 3 program and underscores the tremendous commercial market potential for DURAVYU,” said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint. “We are committed to bringing the first sustained-release TKI to market for patients and physicians in need of a new treatment option for wet AMD. With both pivotal trials continuing to exceed our timelines, we now expect topline data for the LUGANO trial in mid-2026 with LUCIA to follow in the second half of 2026.”

“The excitement for DURAVYU within the retinal community highlights its potential to transform the treatment paradigm for wet AMD patients. It also reflects the strong appeal of our trial design, which is supported by a well-established safety profile in over 190 patients,” said Ramiro Ribeiro, M.D., Ph.D., Chief Medical Officer of EyePoint. “With enrollment in the LUGANO trial completed, our focus is on completing enrollment for the LUCIA trial in the third quarter of 2025. We expect continued strong momentum, with sites outside the US now actively enrolling along with select LUGANO sites preparing to cross over to LUCIA.”

“The pace of enrollment in the LUGANO trial highlights EyePoint’s engagement with the retinal community and underscores the enthusiasm for DURAVYU and the patient-centric pivotal program,” said Brittney Statler, M.D., Principal Investigator in the LUGANO clinical trial and Medical Retina Specialist at Panorama Eyecare. “One of the many compelling elements of this program is the fact that all patients receive active treatment with either aflibercept or DURAVYU enabling us to effectively evaluate the potential next generation of treatment for wet AMD in clinical practice. We are honored to be part of this innovative clinical research for a treatment that has the potential to change the current treatment paradigm and revolutionize clinical outcomes for patients suffering from serious retinal diseases.”

 


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LUGANO and LUCIA are randomized, double-masked, aflibercept controlled, non-inferiority Phase 3 trials assessing the efficacy and safety of DURAVYU in patients with active wet AMD including treatment naïve and treatment experienced patients. The LUGANO trial has enrolled and randomized over 400 patients, and the LUCIA trial is also designed to enroll approximately 400 patients globally who will be randomly assigned to DURAVYU 2.7mg or an on-label aflibercept control. The LUGANO and LUCIA trials are the only sustained release wet AMD pivotal Phase 3 trials evaluating 6-month redosing in both trials over two-years. Patients in the DURAVYU 2.7mg treatment arm will receive an intravitreal dose of DURAVYU every six months, starting at month two of the trial. DURAVYU is delivered via a standard intravitreal injection in the physician's office, similar to current standard practice with FDA approved anti-VEGF treatments. The primary endpoint of the Phase 3 pivotal trials is the average change in best corrected visual acuity (BCVA) at weeks 52 and 56 versus baseline. Secondary endpoints include safety, reduction in treatment burden, percentage of eyes free of supplemental aflibercept injections and anatomical results as measured by optical coherence tomography (OCT). More information about the trial is available at www.clinicaltrials.gov (LUGANO identifier: NCT06668064; LUCIA identifier: NCT06683742).

About Wet AMD

Wet age-related macular degeneration (wet AMD) is a leading cause of vision loss and irreversible blindness in people over the age of fifty. Wet AMD is an advanced form of condition that develops when abnormal blood vessels grow into the macular retina, leaking blood or fluid, and leading to potentially severe vision loss. Wet AMD is a lifelong disease that requires continuous treatment so that patients may maintain visual function. Although multiple treatments are now available, challenges still exist as the current standard-of-care is dosed on average every two months in the United States under a treat-and-extend protocol, and these large molecule anti-VEGF treatments only target one pathology of the disease. This lifetime of frequent treatment represents a tremendous burden for patients, physicians, and the health care system, potentially leading to patient noncompliance and further vision loss.

About DURAVYU™

DURAVYU™, f/k/a EYP-1901, is being developed as a potential sustained-delivery maintenance treatment for patients suffering from chronic VEGF-mediated retinal diseases. DURAVYU delivers vorolanib, a differentiated and patent-protected tyrosine kinase inhibitor (TKI), as a solid bioerodible insert using EyePoint’s proprietary and best-in-class bioerodible Durasert E™ technology. Vorolanib brings a new mechanism of action to the treatment of VEGF-mediated retinal diseases as a potent and highly selective pan-VEGF receptor inhibitor. Benefits of this new mechanistic approach include the demonstration of neuroprotection in an in vivo model of retinal detachment, as well as blockage of PDGF, which may have potential antifibrotic benefits.

DURAVYU has established a robust safety and efficacy profile with the largest TKI intravitreal (IVT) trial dataset in wet AMD to-date. Positive data from Phase 1 and Phase 2 (DAVIO 2) clinical trials of DURAVYU in wet AMD demonstrated clinically meaningful efficacy data with stable visual acuity and CST and a favorable safety profile. Data from DAVIO 2 demonstrated an impressive treatment burden reduction of approximately 88% six months after treatment with DURAVYU, with over 80% of patients supplement-free or receiving only one supplemental anti-VEGF injection. DURAVYU is being studied in two ongoing Phase 3 clinical trials, LUGANO and LUCIA, in wet AMD. The Phase 3 pivotal programs are evaluating re-dosing of DURAVYU with the goal of providing the retina community valuable insight into sustained ‘real-world’ usage of DURAVYU.

 


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DURAVYU is also currently being evaluated for the treatment of diabetic macular edema (DME). The Phase 2 VERONA trial met primary and secondary endpoints and demonstrated an immediate and sustained improvement in vision and anatomy, a continued favorable safety and tolerability profile with superior dosing intervals to standard of care. These positive Phase 2 results support the advancement of the DME program to a Phase 3 pivotal program which will be informed by an EOP2 meeting with FDA.

About EyePoint

EyePoint Pharmaceuticals, Inc. (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™ is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with bioerodible Durasert E™. Supported by robust safety and efficacy data to date, DURAVYU is presently in Phase 3 global, pivotal clinical trials for wet age-related macular degeneration, the leading cause of vision loss among people 50 years of age and older in the United States and recently completed a Phase 2 clinical trial in diabetic macular edema.

The proven Durasert® drug delivery technology has been safely administered to thousands of patient eyes across four U.S. FDA approved products in multiple disease indications. EyePoint is headquartered in Watertown, Massachusetts, and operates a commercial-scale manufacturing facility in Northbridge, Massachusetts.

Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan.

DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product candidate; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain.

Forward Looking Statements

EYEPOINT SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding our expectations regarding our clinical development and regulatory plans of DURAVYU™; our belief that DURAVYU™ is on track to be the first-to-market of the current investigational sustained release treatments for wet AMD; our belief that DURAVYU™ has two potential blockbuster indications; our belief that DURAVYU™’s potential real-world application in multiple retinal disease indications and de-risked trial designs position DURAVYU™ for clinical and commercial success; our expectations regarding timing for the completion of clinical trial enrollment and the timing of the availability and release of clinical data; our belief that rapid trial enrollment in LUGANO and LUCIA highlights physician and patient enthusiasm for DURAVYU™, which we believe is driven by an established and familiar trial design, robust Phase 2 data, and a strong safety profile; our expectations regarding cash runway; our optimism that that DURAVYU™ has the potential to shift the treatment paradigm in wet AMD and DME and improve patient outcomes; our expectations regarding clinical development of our other product candidates, including EYP-2301; our belief that we are well positioned as the leader in ocular sustained drug delivery; our business strategies and objectives; and other statements regarding the Company’s future plans, objectives, strategies and beliefs, as identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” or other words of similar meaning or the use of future dates.

 


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Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, these risks and uncertainties include the timing, progress and results of the company’s clinical development activities, including DURAVYU™; uncertainties and delays relating to communications with the U.S. Food and Drug Administration and the ability to obtain regulatory approval from FDA for the commercialization of DURAVYU™; unanticipated costs and expenses; the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the risk that results of clinical trials may not be predictive of future results, and interim and preliminary data are subject to further analysis and may change as more data becomes available; unexpected safety or efficacy data observed during clinical trials; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for approval of the Company’s product candidates; changes in the regulatory environment; disruptions at the FDA, including due to a reduction in the FDA’s workforce and/or inadequate funding for the FDA; changes in U.S. and international trade policies; changes in expected or existing competition; the success of current and future license agreements; our dependence on contract research organizations, and other outside vendors and service providers; product liability; the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; delays, interruptions or failures in the manufacture and supply of our product candidates; the availability of and the need for additional financing; the company’s ability to obtain additional funding to support its clinical development programs; uncertainties regarding the timing and results of the August 2022 subpoena from the U.S. Attorney’s Office for the District of Massachusetts; uncertainties regarding the FDA warning letter pertaining to the company’s Watertown, MA manufacturing facility; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. A more complete discussion of the risks and uncertainties that may cause our actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading "Risk Factors" in our most recent Annual Report on Form 10-K, in our other filings with the Securities and Exchange Commission (SEC) and in our future reports to be filed with the SEC, which are available at www.sec.gov. Our forward-looking statements speak only as of the dates on which they are made. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

Investors:

Tanner Kaufman / Jenni Lu FTI Consulting Direct: 203-722-8743 / 667-321-6018 Tanner.Kaufman@fticonsulting.com / jenni.lu@fticonsulting.com

 


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Media Contact:

Amy Phillips

Green Room Communications

Direct: 412-327-9499

aphillips@greenroompr.com

 


EX-99.2 3 eypt-ex99_2.htm EX-99.2

Slide 1

Investor Presentation May 2025 ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Exhibit 99.2


Slide 2

Legal Disclaimers ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Various statements made in this presentation are forward-looking, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect, plan or believe may occur in the future, are forward-looking statements, including but not limited to statements regarding: our expectations regarding our clinical development and regulatory plans; our expected timing for the completion of clinical trial enrollment and the timing of the availability and release of clinical data; our expected cash runway; our optimism that DURAVYU has the potential to change the current treatment paradigm and revolutionize real-world outcomes for patients suffering from serious retinal diseases; our belief that DURAVYU has the potential to maintain a majority of patients with active disease with no supplemental anti-VEGF therapy for six months or longer; our expectations regarding our manufacturing capabilities; and our expectations regarding the timing and clinical development of our other product candidates, including EYP-2301. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, these risks and uncertainties include the timing, progress and results of the company’s clinical development activities, including DURAVYU; uncertainties and delays relating to communications with the U.S. Food and Drug Administration and the ability to obtain regulatory approval from FDA for the commercialization of DURAVYU; unanticipated costs and expenses; the Company’s cash and cash equivalents may not be sufficient to support its operating plan for as long as anticipated; the risk that results of clinical trials may not be predictive of future results, and interim and preliminary data are subject to further analysis and may change as more data becomes available; unexpected safety or efficacy data observed during clinical trials; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for approval of the company’s product candidates; changes in the regulatory environment; disruptions at the FDA, including due to a reduction in the FDA’s workforce and/or inadequate funding for the FDA; changes in U.S. and international trade policies; changes in expected or existing competition; the success of current and future license agreements; our dependence on contract research organizations, and other outside vendors and service providers; product liability; the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; delays, interruptions or failures in the manufacture and supply of our product candidates; the availability of and the need for additional financing; our ability to obtain additional funding to support our clinical development programs; uncertainties regarding the timing and results of the August 2022 subpoena from the U.S. Attorney’s Office for the District of Massachusetts; uncertainties regarding the FDA warning letter pertaining to our Watertown, MA manufacturing facility; and other factors described in our filings with the Securities and Exchange Commission (SEC). More detailed information on these and additional factors that could affect our actual results are described in our filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as revised or supplemented by its Quarterly Reports on Form 10-Q and other documents filed with the SEC. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.


Slide 3

The Leader in Sustained Release Drug Delivery for Retinal Disease ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Highly positive efficacy and safety data in DME from VERONA Phase 2 trial $318M at 3/31/25 – runway into 2027 post Phase 3 LUGANO/LUCIA data in 2026 DURAVYU™: vorolanib - best-in-class, patent protected TKI in Durasert E™ sustained delivery technology Favorable safety profile across multiple indications in 190+ patients TKI tyrosine kinase inhibitor; wet AMD, wet age-related macular degeneration; DME, diabetic macular edema Pivotal Phase 3 trial in wet AMD, LUGANO fully enrolled; LUCIA over 60% enrolled and randomized


Slide 4

©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. wet AMD, wet age-related macular degeneration; DME, diabetic macular edema; PK, pharmacokinetic; GA, geographic atrophy Pipeline Leveraging Durasert E™ Drug Delivery Technology Pursuing Large Market Opportunities trial underway non-clinical Durasert E™ Programs Indication Discovery Pre-Clin Phase 1 Phase 2 Phase 3 Anticipated Next Milestone DURAVYU™ – (vorolanib intravitreal insert) (f/k/a EYP-1901) Wet AMD DME EYP-2301 – razuprotafib (TIE-2 agonist) serious retinal diseases LUCIA full enrollment 3Q 25 FDA EOP2 July 2025 Pre-clin tox and PK data LUGANO fully enrolled – topline data mid-2026 Positive 24-Week Data Evaluating additional pipeline opportunities


Slide 5

Chronic disease treated with short acting anti-VEGFs places significant burden on physicians and patients 77% of Retina Specialists say improved durability is most important when choosing a treatment2. A delay in care/missed visit can result in vision loss A delay in treatment of only 5.34 weeks resulted in vision loss3 An increasing lifespan means significantly more injections in a patient’s lifetime Current anti-VEGF treatments are dosed on average every two months in the United States4 Many patients with wet AMD are chronically undertreated >80% of Retina Specialists say undertreatment is due to patient noncompliance, scheduling limitations or provider preference for less frequent dosing1 1. 2022 PAT Survey; 2. 2024 PAT Survey; 3. American Academy of Ophthalmology, The Effect of Delay in Care Among Patients Requiring Intravitreal Injections, Welin Song, BS et al; 4. NIH Current and Upcoming Anti-VEGF Therapies and Dosing Strategies for the treatment of wet AMD: a comparative review, Saira Khanna et al, Dec. 2019 There is a Significant Need for More Durable Therapies in Wet AMD 1 2 3 4


Slide 6

Diabetic Macular Edema: Large Market Opportunity with Significant Unmet Need for More Durable Treatments ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 1. William R. Rowley, Clement Bezold, Yasemin Arikan, et al. Diabetes 2030: Insights from Yesterday, Today and Future Trends. PubMed Central. 2017 PMCID: PMC5278808  PMID: 27124621 . 2. Russel Lazarus. Optometrists Network. Guide to Eye Conditions; Diabetic Macular Edema. 3. DelveInsights DME Market Report -2030. 4. Monique A. Rose, Meri Vukicevic, Konstandina Koklanis. Adherence of patients with diabetic macular oedema to intravitreal injections: A systematic review. PubMed 2020 PMID: 32829485 DOI: 10.1111/ceo.13845. 5. Lee, R., Wong, T.Y. & Sabanayagam, C. Epidemiology of diabetic retinopathy, diabetic macular edema and related vision loss. Eye and Vis 2, 17 (2015). https://doi.org/10.1186/s40662-015-0026-2. 6. Nagda D, Mitchell W, Zebardast N. The functional burden of diabetic retinopathy in the United States. Graefes Arch Clin Exp Ophthalmol. 2021;259(10):2977–2986. https://doi.org/10.1007/s00417-021-05210-3. Patients in the US with diabetes by 20301 Global branded market by 20303 Delayed/missed treatment visits4 54.9M 25% up to 51% $3.0B Develop DME within 10 years2 Vision loss from missed injection5 5-6 letters By 2050, diabetes-related vision loss is expected to cost 500 million US dollars annually6


Slide 7

IVT, intravitreal DURASERT E™ TECHNOLOGY Sustained-Release Drug Delivery Standard in-office IVT injection Continuous dosing Zero-order kinetics drug release Solid injectable insert Drug formulated within a bioerodible matrix Designed to release drug load before matrix fully erodes Favorable safety profile across multiple indications No non-erodible polyamide coating from legacy Durasert technology ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Insert is 1/5000 of Vitreous Volume​


Slide 8

1. Bakri SJ, et al. PLoS One. 2024;19(6):e0304782. 2. Patel S, et al. Ophthalmol Sci. Sep-Oct 2024;4(5):100527. 3. Wykoff CC et al. J Vitreoretin Dis. Sep-Oct 2024;8(5):577-586. ANG, angiopoietin; IVT, intravitreal; TIE2, tyrosine-protein kinase receptor TIE-2; TKI, tyrosine kinase inhibitor; VEGF(R), vascular endothelial growth factor (receptor). DURAVYUTM: Vorolanib in bioerodible Durasert ETM DURAVYU vorolanib intravitreal insert No delay – reaches target tissues at therapeutic levels within hours of administration No fluctuation – delivered as a continuous dose with zero-order kinetics No free-floating drug particles – fully eluted before matrix bioerosion No cold storage needed – shipped and stored at ambient temperature No PEG or PLGA – no risk of PEG-induced inflammation Controlled release for at least 6 months ANGIOGENESIS TIE2 ANG2 ANG1 INTRACELLULAR EXTRACELLULAR Blood Vessel Stability VEGF-A VEGF-D VEGF-C PLGF VEGF-B VEGFR-1 VEGFR-2 VEGFR-3 ⨯ VOROLANIB ⨯ ⨯ Aflibercept Faricimab Vorolanib Patented and potent receptor tyrosine kinase inhibitor (TKI): selectively inhibits all VEGF signaling Durasert E Bioerodible, sustained IVT drug delivery DURAVYU Bioerodible insert Insert is: 94% drug / 6% matrix 1/5000th of vitreous volume


Slide 9

©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DURAVYU Demonstrated Positive Efficacy Outcomes and Excellent Safety Profile Across Multiple Indications BCVA, best-corrected visual acuity; OCT, optical coherence tomography; wet AMD, wet age-related macular degeneration; NPDR, non-proliferative diabetic retinopathy; DME, diabetic macular edema DURAVYU Has Been Evaluated in >190 Patients to Date Across Multiple Indications 17 patients received DURAVYU DAVIO Phase 1 Wet AMD Favorable safety profile No DURAVYU–related ocular or systemic SAEs Stable BCVA and OCT 74% reduction in treatment burden 102 patients received DURAVYU DAVIO 2 Phase 2 Wet AMD Statistically non-inferior BCVA compared to aflibercept >80% reduction in treatment burden Stable OCT 51 patients received DURAVYU PAVIA Phase 2 NPDR Prevent worsening of disease severity 21 patients received DURAVYU VERONA Phase 2 DME Met primary and secondary endpoints Immediate and sustained improvement in vision with corresponding anatomical control


Slide 10

©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. LUGANO/LUCIAPhase 3 Pivotal Trials in wet AMD NON-INFERIORITY VERSUS AN AFLIBERCEPT CONTROL


Slide 11

DURAVYU De-Risked Clinical Approach in Wet AMD ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Established FDA approval Path Last four FDA approvals followed the noninferiority pathway Recent superiority trial failure Completed robust Phase 2 trial Derisked and informed Phase 3 Statistically non-inferior to “on-label” aflibercept in tough to treat population Proactive FDA interaction Formal EOP2 and Type C meetings Written alignment on NI trial design and -4.5 NI margin Patient-focused approach Real-world trial design measured against on-label standard of care All patients receive treatment with the goal of maintaining vision wet AMD, wet age-related macular degeneration; EOP2, End of Phase 2; NI, noninferiority


Slide 12

©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Ongoing DURAVYU Phase 3 Trials in Wet AMD Supported by Phase 2 DAVIO 2 Results - All Primary and Secondary Endpoints Met DAVIO2 Endpoint 2mg 3mg R Primary: Non-inferior change in BCVA vs. aflibercept - 0.3 letters - 0.4 letters R Secondary: Favorable safety profile No DURAVYU-related SAEs R Secondary: Reduction in treatment burden vs. 6 mos. prior 89% 85% R Secondary: Reduction in treatment burden vs. aflibercept 82% 76% R Secondary: Supplement-free up to 6 months 63% 88% of eyes had 0 or 1 supplemental injections 63% 83% of eyes had 0 or 1 supplemental injections R Secondary: Anatomical control vs. aflibercept +12.4um +5.2um


Slide 13

Phase 3 Pivotal Trials - Designed to Evaluate Non-Inferiority of DURAVYU vs Aflibercept Control ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Screening D1 W4 W8 W12 W16 W24 W32 W84-W92 W20 W28 DURAVYU™ 2.7mg Aflibercept 2mg q8W RANDOMIZATION REQUIRED AFLIBERCEPT INJECTION VISIT VISIT SCHEDULED DURAVYU™ DOSE AFLIBERCEPT q8W 1⁰ ENDPOINT BLEND W52 AND W56; UNMASK W56 SHAM INJECTION FOR MASKING W36 W40 W44 W48 W52 W56 W60-W76 W80 W96 EOS AFLIBERCEPT Q8W Sham injection For Masking Supplemental anti-VEGF injection based on strict criteria AFLIBERCEPT load DURAVYU DURAVYU DURAVYU DURAVYU LUGANO enrollment complete; LUCIA full enrollment expected 3Q 2025


Slide 14

Phase 3 Clinical Trials for DURAVYU in wet AMD Seeing Exceptional Enrollment Rates Driven by Significant Investigator and Patient Enthusiasm ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. *Screening is closed for the LUGANO pivotal Phase 3 trial. Over 400 patients are enrolled and randomized. Any remaining patients in screening at the time of screening closure may also be randomized into the trial over the next several weeks. 3Q 2025 LUCIA full enrollment anticipated LUGANO topline data anticipated in mid-2026 LUCIA topline anticipated in 2H 2026 January 2025 LUGANO trial ~1/3 enrolled; LUCIA exceeding expectations 3Q 2026 Topline data for LUGANO (LUCIA to quickly follow) February 28, 2025 LUGANO trial >50% enrolled; LUCIA exceeding expectations March 10, 2025 LUGANO 60% enrolled; LUCIA exceeding expectations May 2, 2025 LUGANO >90% enrolled LUCIA >50% enrolled May 23, 2025 LUGANO enrollment complete* LUCIA 60% enrolled


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©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Phase 2 VERONA Clinical Trial in DME 24 Week results Primary and secondary endpoints achieved DME, diabetic macular edema


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DURAVYU is Uniquely Positioned to Provide an Improved DME Treatment Paradigm Compared to Current Anti-VEGF Therapies ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 24-Month Treatment Regimens for DME: 2–4-month dosing 1-4-month dosing Anti-VEGF SoC DURAVYU™ (vorolanib intravitreal insert)* 2-month dosing 1-month dosing 6-month dosing *Potential positioning for DURAVYU, if approved, based on Phase 3 protocol for wet AMD. SoC, standard of care


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©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DME, diabetic macular edema; VEGF, vascular endothelial growth factor; BCVA, best corrected visual acuity; OCT, optical coherence tomography; CST, central subfield thickness DURAVYU dosing Visit Scheduled aflibercept injection Sham injection DURAVYU 1.3mg (n=10) DURAVYU 2.7mg (n=11) Aflibercept 2mg single injection (n=6) Supplemental Anti-VEGF injection based on prespecified criteria Objectives: Evaluate the safety and efficacy of DURAVYU in patients with active DME (CST >325μm) Collect dose-ranging data to inform Phase 3 clinical trials Primary endpoint: time to supplemental anti-VEGF injection up to week 24 Key Secondary endpoints: safety, change in BCVA vs. aflibercept control and anatomical control (CST) First clinical trial to evaluate higher payload inserts (1.34mg) -D28 to -D7 D1 W4 W8 W12 W16 W20 W24 The VERONA Phase 2 Clinical Trial is the First Trial DURAVYU was Evaluated in Patients with Active Disease Randomized, Open-Label, Aflibercept Controlled Trial as a Potential Treatment for DME Primary endpoint


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VERONA:Phase 2 Clinical Trial Met Primary and Key Secondary EndpointsData supports DURAVYU as a Potential Treatment for DME with improvement in vision and anatomy with superior dosing intervals ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DURAVYU 2.7mg EFFICACY: Primary endpoint achieved - extended time to first supplemental injection vs. aflibercept control Early and sustained BCVA improvement = +7.1 letters Early and sustained CST improvement = -76 microns DURAVYU SAFETY Results: No DURAVYU-related ocular or systemic SAEs No cases of: Impaired vision Endophthalmitis Retinal vasculitis (occlusive or non-occlusive) Intraocular inflammation (IOI) Insert migration DME, diabetic macular edema; BCVA, best-corrected visual acuity; CST, central subfield thickness; SAEs, serious adverse events.


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©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Single DURAVYU 2.7mg Treatment Demonstrated Clinically Meaningful Improvement in BCVA; Supports Noninferiority in Pivotal Trial BCVA, best-corrected visual acuity; VA, visual acuity MEAN CHANGE IN BCVA FROM BASELINE +7.1 +7.3 DURAVYU 2.7mg -0.2 Mean Change in BCVA vs Aflibercept +6.9 Early and sustained VA improvement


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©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Excluding a Single Outlier Patient, DURAVYU 2.7mg Improved +10 Letters vs. Baseline; Nearly +3 Letters Better than Control BCVA, best-corrected visual acuity; VA, visual acuity MEAN CHANGE IN BCVA FROM BASELINE Excluding Outlier Patient +10.1 +7.3 DURAVYU 2.7mg (ex outlier) +2.8 Mean Change in BCVA vs Aflibercept Outlier patient missed multiple visits including the Week 20 visit resulting in vision loss of >20 letters at the Week 24 visit.


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©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DURAVYU 2.7mg Demonstrated Improved and Controlled Anatomy with 74% More Drying than Aflibercept Control CST: central subfield thickness Source: Independent reading center results available as of the full 24-week data cut. MEAN CHANGE IN CST FROM BASELINE -75.9 um -43.7 um Mean Change in CST vs Aflibercept -71.1 um DURAVYU 2.7mg -32.2 um


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©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Phase 2 VERONA Clinical Trial in DME Sub-Group Analysis Of Patients Supplement-free at 24 Weeks DME, diabetic macular edema


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©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Sub-Group of Supplement-Free Patients Demonstrated Eyes Treated with DURAVYU 2.7mg had Better Visual and Anatomical Outcomes BCVA, best-corrected visual acuity; VA, visual acuity MEAN CHANGE IN BCVA FROM BASELINE +10.3 +3.0 Mean Change in BCVA vs Aflibercept +6.5 DURAVYU 2.7mg +7.3 Supplement-free is defined as patients who did not receive a supplement at any point during the study. MEAN CHANGE IN CST FROM BASELINE Mean Change in BCVA vs Aflibercept DURAVYU 2.7mg -73.7 -117.4 um -43.7 um -30.8 um


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VERONA Clinical Trial Case Study 1 - Rapid Drying with Improved Vision After Single DURAVYU 2.7mg Treatment and No Supplementation ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Screening BCVA 50 Aflibercept + 2.7mg DURAVYU -12 -11 -10 -9 -8 -7 -6 -5 -4 -3 -2 -1 Day1 1 2 3 4 5 6 Eylea Eylea Vabysmo washout BCVA 46 Day 1 BCVA 67 Month 4 BCVA 66 Month 6 Month 1 BCVA 65 Day 1 (2.7mg DURAVYU insert) Case 1: SOC Anti-VEGF Injections Before and After Treatment BCVA, best-corrected visual acuity


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VERONA Clinical Trial Case Study 2 - Continued Drying at Week 24 with Improved VA After Single DURAVYU 2.7mg Treatment and No Supplementation ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Screening BCVA 72 Aflibercept + 2.7mg DURAVYU -12 -11 -10 -9 -8 -7 -6 -5 -4 -3 -2 -1 Day1 1 2 3 4 5 6 Avastin Vabysmo washout BCVA 73 Day 1 BCVA 80 Month 4 BCVA 80 Month 6 Month 1 BCVA 74 Day 1 (2.7mg DURAVYU insert) Case 2: SOC Anti-VEGF Injections Before and After Treatment VA, visual acuity; BCVA, best-corrected visual acuity


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VERONA: Phase 2 Clinical Trial Summary ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Primary endpoint met for both DURAVYU doses Demonstrated immediate and clinically meaningful results without a full load of aflibercept Significant improvement in vision and anatomic results paired with a meaningful reduction in treatment burden Sub-group analysis of supplement-free eyes demonstrated results are driven by treatment with DURAVYU and not by supplemental injections Continued favorable safety and tolerability EOP2 meeting scheduled with FDA in July 2025 to solidify plans for pivotal program


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State-Of-The-Art cGMP Manufacturing Facility to Support DURAVYU through Phase 3 and Global Commercial Production ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. cGMP, current good manufacturing practices; FDA, Federal Drug Administration; EMA, European Medicines Agency; cGMP, current good manufacturing practice Located in Northbridge, MA Built to US FDA and EU EMA standards DURAVYU registration batches in-motion to support future NDA filing Built to EYPT specifications by landlord preserving upfront cash investment 40,000sf+ commercial manufacturing site


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On Track for Continued Execution And Well-Funded Through Key Anticipated DURAVYU Milestones ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DME, diabetic macular edema; EOP2, End of Phase 2; wet AMD, wet age-related macular degeneration; SAB, Scientific Advisory Board DURAVYU™ Corporate ✓ DAVIO 2 12-month data June 2024 ✓ Positive interim VERONA data October 2024 ✓ First patient dosed – LUGANO October 2024 ✓ First patient dosed – LUCIA December 2024 ✓ VERONA Phase 2 DME full 24-week data February 2025 ✓ VERONA Phase 2 subgroup analyses March 2025 ✓ Completed enrollment of LUGANO Phase 3 trial in wet AMD May 2025 FDA EOP2 meeting for DME July 2025 Full enrollment of LUCIA Phase 3 trial in wet AMD 3Q 2025 Topline data for LUGANO Mid-2026 ✓ R&D Day - NYC June 2024 ✓ Fred Hassan appointed to Board of Directors September 2024 ✓ Northbridge manufacturing facility grand opening October 2024 ✓ Reginald Sanders, MD appointed to Board of Directors January 2025


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Investor Presentation May 2025 ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved.