EyePoint, Inc 8-K/A, filed Jul 29, 2025
EyePoint, Inc. (EYPT)
About this 8-K/A
EyePoint, Inc filed this 8-K/A on July 29, 2025.
Items reported
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K/A
CURRENT REPORT
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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).
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Explanatory Note
Item 8.01 Other Events.
On July 29, 2025, EyePoint Pharmaceuticals, Inc. (the “Company”) issued a press release announcing it has completed enrollment in the pivotal Phase 3 clinical trials evaluating DURAVYU™ 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. |
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Description |
99.1 |
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Press Release of EyePoint Pharmaceuticals, Inc. dated July 29, 2025 |
99.2 |
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Investor Presentation of EyePoint Pharmaceuticals, Inc. dated July 29, 2025 |
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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.
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EYEPOINT PHARMACEUTICALS, INC. |
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July 29, 2025 |
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/s/ George O. Elston |
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George O. Elston |
Exhibit 99.1
EyePoint Completes Enrollment of Pivotal Phase 3 Trials for DURAVYU™ in Wet Age-Related Macular Degeneration
WATERTOWN, Mass., July 29, 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 completed enrollment of its Phase 3 pivotal program with the full enrollment of the LUCIA trial, the second of two identical ongoing pivotal non-inferiority trials evaluating DURAVYU™ for the treatment of wet age-related macular degeneration (wet AMD). The first pivotal trial, LUGANO, completed enrollment in May 2025. The LUCIA trial has enrolled and randomized over 400 patients in seven months making DURAVYU one of the fastest enrolling Phase 3 pivotal programs in wet AMD.
The Company also announced that based on interim masked safety data, the safety profile observed in LUGANO and LUCIA is consistent with previous DURAVYU clinical trials. DURAVYU has been evaluated in over 190 patients across four clinical trials demonstrating a favorable safety and tolerability profile including no DURAVYU related ocular or systemic serious adverse events observed. In parallel, an independent Data Safety Monitoring Committee (“DSMC”) convened and recommended continuation of the program as planned.
LUGANO and LUCIA are supported by the robust safety and efficacy data from the DAVIO 2 Phase 2 clinical trial. The Phase 3 pivotal program was developed in alignment with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), follows recognized industry best practices, and is strategically designed to enhance the potential for regulatory and commercial success. All patients are randomized on Day One and immediately begin treatment with a one-year efficacy and safety endpoint to support an NDA filing. With the completion of enrollment for LUCIA, topline data is anticipated to follow shortly after topline data for LUGANO which is expected in mid-2026.
“With enrollment now complete for our Phase 3 wet AMD program, well ahead of our expectations, we continue to demonstrate exceptional execution and our deep commitment to the retinal disease community,” said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint. “The industry-leading pace of our clinical program is a testament to the patient and physician enthusiasm for innovative, novel and more durable wet AMD treatments and DURAVYU’s compelling and differentiated profile. As we look ahead to anticipated topline data for LUGANO in mid-2026 and LUCIA to follow, we remain
focused on bringing the first sustained-release TKI for wet AMD to market and advancing our mission of delivering transformative treatment options for patients.”
“Similar to our LUGANO trial, LUCIA has exceeded enrollment timelines, underscoring our clinical development leadership and continued recognition by the retinal community of DURAVYU’s best-in-class profile,” said Ramiro Ribeiro, M.D., Ph.D., Chief Medical Officer at EyePoint. “We are proud of the clinical rigor and patient-centric approach underpinning our Phase 3 program, including our real-world design, which has now been approved by both the U.S. and European regulatory bodies, as well as use of an on-label standard of care comparator that resonates with physicians. LUCIA also marked our expansion beyond the U.S. with patient participation in South America, Europe, Israel, Australia and India, demonstrating global momentum and interest in DURAVYU. We are excited to be one step closer towards bringing our innovative sustained-release TKI to wet AMD patients seeking more durable therapies that reduce the treatment burden.”
“The rapid enrollment of the LUCIA trial reflects its patient-centric design, DURAVYU’s excellent safety profile, and EyePoint’s ongoing engagement with the retinal community,” said Anat Loewenstein, M.D., MHA, Vice President Ambulatory Services, Head of Retina Tel Aviv Medical Center, President of European Society of Retina Specialists (EURetina) and member of EyePoint’s Scientific Advisory Board. “With its use of a non-inferiority design and on-label aflibercept control, EyePoint’s Phase 3 program is designed to generate data that is relevant to clinical practitioners like myself. Additionally, the 6-month redosing schedule being evaluated would enable greater clinical flexibility and improved compliance for patients, representing a potential paradigm shift for the treatment of wet AMD. It is my pleasure to contribute to this cutting-edge research, which holds the promise of improving outcomes for retinal disease patients worldwide.”
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. Enrollment is complete in both trials with each enrolling over 400 patients enrolled and randomized 1:1 to receive either 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™ (vorolanib intravitreal insert, f/k/a EYP-1901), is being developed as a potential sustained-delivery treatment for patients suffering from VEGF-mediated retinal diseases. It is designed to be administered intravitreally in a pre-loaded syringe injector and deliver a daily therapeutic dose for at least six months. DURAVYU combines vorolanib in the Durasert E™ technology: Durasert E is EyePoint’s proprietary and best-in-class bioerodible sustained release insert with a matrix designed to prevent free-floating drug particles and contains no PEG or PLGA; vorolanib is a differentiated and patent-protected tyrosine kinase inhibitor (TKI) and is the most studied TKI in retinal disease, with proven ocular safety and no TIE2 inhibition. Vorolanib brings a novel mechanism of action to the treatment of VEGF-mediated retinal diseases as it works intracellularly to inhibit all VEGF receptors. 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 efficacy data across approximately 140 wet acute macular degeneration (wet AMD) and diabetic macular edema (DME) patients in both Phase 1 and 2 trials that demonstrate stability in vision and anatomical control with fewer injections. Data from the Phase 2 trial 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. Importantly, no safety signals or ocular SAEs related to DURAVYU have been observed in 190+ patients across four clinical trials, including three Phase 2 trials.
An ongoing Phase 3 pivotal program, consisting of two trials, LUGANO and LUCIA, is evaluating re-dosing of DURAVYU in wet AMD. The Phase 3 pivotal program follows a well-established regulatory approval pathway with a patient-centric non-inferiority design comparing DURAVYU to on-label standard of care to inform real-word treatment practices.
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 a rapid 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 and the Company recently completed a positive End-of-Phase 2 meeting with the FDA.
About EyePoint
EyePoint Pharmaceuticals, Inc. (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. The Company’s lead product candidate, DURAVYU™, is an innovative investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor (TKI), in next-generation bioerodible Durasert E™ technology. Supported by robust safety and efficacy data to date, DURAVYU is currently being evaluated in two Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD) with topline data anticipated in 2026. DURAVYU also completed a positive Phase 2 clinical trial in diabetic macular edema (DME) with Phase 3 pivotal planning underway. Despite current therapies, patients with wet AMD and DME still tend to lose vision in the long term and wet AMD is the leading cause of vision loss among people 50 years of age and older in the United States.
The Company is committed to partnering with the retina community to improve patient lives while creating long-term value, with four approved drugs over three decades and tens of thousands of eyes treated with EyePoint innovation.
EyePoint is headquartered in Watertown, Massachusetts, with a commercial 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; 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.
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
Media Contact:
Amy Phillips
Green Room Communications
Direct: 412-327-9499
aphillips@greenroompr.com
Investor Presentation July 2025 ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Exhibit 99.2
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.
The Leader in Sustained Release Drug Delivery for Retinal Disease ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Compelling efficacy and safety data in DME from VERONA Phase 2 trial; positive EOP2 meeting with FDA $318M at 3/31/25 – runway into 2027 post Phase 3 pivotal data in 2026 DURAVYU™: vorolanib - best-in-class, patent protected TKI in next-generation Durasert E™ sustained delivery technology Favorable safety profile across four clinical trials in 190+ patients TKI tyrosine kinase inhibitor; wet AMD, wet age-related macular degeneration; DME, diabetic macular edema LUGANO and LUCIA Phase 3 wet AMD trials fully enrolled >800 patients randomized
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. wet AMD, wet age-related macular degeneration; DME, diabetic macular edema; EOP2, End-of-Phase 2; PK, pharmacokinetic; GA, geographic atrophy Pipeline Leveraging Bioerodible 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 LUGANO topline data expected in mid 2026; LUCIA to closely follow Pivotal program in 2026 Tox and PK data LUGANO and LUCIA fully enrolled Positive EOP2 meeting with FDA Evaluating additional pipeline opportunities
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 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 Despite current therapies, patients with wet AMD still lose vision in the long term 1 2 3 4
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
Inserts not drawn to scale, for illustrative purposes only. aVitrasert now discontinued. IVT, intravitreal; PEG, polyethylene glycol; PLGA, poly lactic-co-glycolic acid. Durasert E™: The Next Generation in Sustained-Release Intravitreal Drug Delivery Vitrasert® (ganciclovir IVT)a Retisert® (fluocinolone acetonide) ILUVIEN® (fluocinolone acetonide) YUTIQ® (fluocinolone acetonide) EYP-1901 (vorolanib IVT insert) DURAVYU (EYP-1901) (vorolanib IVT insert) Durasert® Durasert E™ Nonerodible Bioerodible 1030 µg payload Bioerodible High payload (1343 µg) Over three decades of innovation in sustained-release drug delivery
*Data from preclinical studies; 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). DURAVYU™: Vorolanib in Bioerodible Durasert E™ DURAVYU Immediate* No delay - reaches target tissues at therapeutic levels within hours Consistent* Delivers a continuous daily therapeutic dose with no fluctuations Sustained VEGF receptor inhibition for at least six months Controlled Full elution of vorolanib before matrix bioerodes; no free-floating drug particles Convenient shipped and stored at ambient temperature; administered in a pre-loaded syringe injector 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: most studied TKI in retinal disease Novel MOA: Selective and potent TKI that works intracellularly to inhibit all VEGFRs Durasert E Bioerodible, sustained IVT drug delivery Insert is 94% drug and 1/5000th of vitreous volume Contains no PEG or PLGA
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DURAVYU™ Demonstrated Robust Efficacy Outcomes and an 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 Four Clinical Trials 17 patients received DURAVYU DAVIO Phase 1 Wet AMD Favorable safety and tolerability profile No safety signals or ocular SAEs related to DURAVYU 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 Rapid and sustained improvement in vision and anatomical control with fewer injections
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. LUGANO/LUCIA Phase 3 Pivotal Trials in wet AMD NON-INFERIORITY VERSUS ON-LABEL AFLIBERCEPT CONTROL Fully Enrolled
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 On label control arm – patients randomized on Day 1 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-Centric approach All patients receive treatment with the goal of maintaining or improving vision Trial designed to inform real-world treatment practices nAMD, neovascular age-related macular degeneration; EOP2, End of Phase 2; NI, noninferiority
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Positive Phase 2 DAVIO 2 Results in Wet AMD Support Ongoing DURAVYU Phase 3 Pivotal Program 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 Achieved All Primary and Secondary Endpoints
Phase 3 Pivotal Trials - Designed to Evaluate Non-Inferiority of DURAVYU vs On-Label 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 and LUCIA enrollment complete
Exceptional Enrollment in Pivotal Phase 3 Wet AMD Program Driven by Strong Enthusiasm for the DURAVYU Pivotal Program ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. July 2025 LUCIA enrollment complete (>400 patients)* >800 patients enrolled and randomized across LUGANO and LUCIA January 2025 LUGANO trial ~1/3 enrolled; LUCIA exceeding expectations Mid- 2026 Topline data for LUGANO (LUCIA to 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 2025 LUGANO enrollment complete (n=432) LUCIA 60% enrolled *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.
©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
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
VERONA: DURAVYU demonstrated stability in vision and anatomical control with fewer injections in patients with DME ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DURAVYU 2.7mg EFFICACY: Primary endpoint met - extended time to first supplemental injection vs. aflibercept control Key secondary endpoints met: Rapid and sustained BCVA improvement = +10.1* letters Rapid and sustained CST improvement = -76 microns DURAVYU SAFETY Results: No safety signals or ocular SAEs related to DURAVYU No cases of: Impaired vision Endophthalmitis Retinal vasculitis (occlusive or non-occlusive) Intraocular inflammation (IOI) Insert migration *Data excludes one outlier patient. Outlier patient was removed from analysis because the patient missed multiple visits including the Week 20 visit resulting in vision loss of >20 letters at the Week 24 visit DME, diabetic macular edema; BCVA, best-corrected visual acuity; CST, central subfield thickness; SAEs, serious adverse events.
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DURAVYU 2.7mg* Improved +10 Letters vs. Baseline; Nearly +3 Letters Better than Control at 24 Weeks *Data excludes one outlier patient. Outlier patient was removed from analysis because the patient missed multiple visits including the Week 20 visit resulting in vision loss of >20 letters at the Week 24 visit. BCVA, best-corrected visual acuity; VA, visual acuity MEAN CHANGE IN BCVA FROM BASELINE +10.1 +7.3 DURAVYU 2.7mg* +2.8 Mean Change in BCVA vs Aflibercept +6.9
©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DURAVYU 2.7mg Demonstrated Improved Anatomical Control 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
©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
VERONA 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 Months
VERONA Case Study 2 – Better VA and Drying Than Vabysmo 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 Months
VERONA: Phase 2 Clinical Trial Summary ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Primary endpoint met for both DURAVYU doses Demonstrated rapid 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 Positive End-of-Phase 2 meeting with FDA; pivotal program in 2026
State-Of-The-Art cGMP Manufacturing Facility to Support DURAVYU through Potential NDA Filing 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 underway to support future NDA filing Built to EYPT specifications by landlord preserving upfront cash investment 41,000sf commercial manufacturing
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 ✓ 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 DME pivotal plans 2H 2025 Topline data for LUGANO/LUCIA 2026 ✓ 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 ✓ Initiated DURAVYU registration batches in Northbridge June 2025
Investor Presentation July 2025 ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved.