DEF 14A

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

SCHEDULE 14A

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EyePoint Pharmaceuticals, Inc.

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480 Pleasant Street, Suite C400 Watertown, MA 02472 United States

April 28, 2025 To Our Stockholders, 2024 was a year of continued execution and exceptional results for EyePoint as we advanced, DURAVYU™ (vorolanib intravitreal insert), our potential best-in-class sustained delivery therapy, across clinical programs in the two largest retinal disease markets, wet age-related macular degeneration (AMD) and diabetic macular edema (DME).		We are well-positioned as the leader in sustained ocular drug delivery with the potential to transform the treatment landscape with innovative therapies to improve both the vision and the lives of patients with serious retinal diseases.
We are well-positioned as the leader in sustained ocular drug delivery with the potential to transform the treatment landscape with innovative therapies to improve both the vision and the lives of patients with serious retinal diseases. Our pipeline leverages our proprietary, best-in-class, bioerodible Durasert E™ drug delivery technology which provides a sustained release intravitreal insert for treating retinal diseases. This technology utilizes a fully bioerodible matrix that allows for the sustained delivery of drugs via zero-order kinetics release for at least six months. Further, Durasert E provides immediate bioavailability and, by design, prevents free-floating drug particles in the eye. Durasert® has been safely delivered to tens of thousands of eyes across four FDA approved products, meaning both patients and physicians are comfortable with this delivery system and its established safety record. In 2024, we made great progress with DURAVYU, an investigational sustained release product candidate that consists of vorolanib, a potent and selective tyrosine kinase inhibitor (TKI), formulated in Durasert E. We continued our record of strong execution with the initiation of two global Phase 3 pivotal trials in wet AMD, named LUGANO and LUCIA. Both trials have received exceptional investigator and patient enthusiasm to date, driven by an established and familiar trial design, robust Phase 2 data and a strong safety data profile. The rapid enrollment rates to date continue to exceed the observed recruitment rates of comparable historical and ongoing wet AMD trials		underscoring the investigator enthusiasm for DURAVYU and the trial design. The identical non-inferiority trials with every six-month dosing follow a clear and recognized pathway for potential global regulatory and commercial success, positioning DURAVYU to become a potential blockbuster franchise. Looking ahead, we expect full enrollment of both trials in the second half of 2025 with topline data anticipated in 2026. In February 2025, we announced positive 24-week data for the Phase 2 VERONA clinical trial of DURAVYU for DME meeting primary and secondary endpoints. Visual and anatomical gains were observed as early as Week 4 and sustained through 24 weeks demonstrating the immediate bioavailability of DURAVYU and its differentiated profile as a sustained-release TKI with a continued favorable safety and tolerability profile. The positive results were underscored by a supplement-free patient subgroup analyses demonstrating that DURAVYU 2.7mg significantly improved vision and fluid compared to the aflibercept control group. Based on positive Phase 2 results from the VERONA clinical trial we plan to meet with U.S. FDA in the second quarter of 2025 to confirm plans for a pivotal Phase 3 program. DURAVYU brings a new mechanistic approach to the treatment of VEGF-mediated retinal diseases through intracellular blocking of all VEGF receptors, inhibiting all isoforms of VEGF, potentially resulting in enhanced treatment benefit and extended durability. DURAVYU was evaluated in the largest Phase 2 clinical trial to date

      (DAVIO 2) of all sustained delivery programs currently in development, meeting all primary and secondary endpoints. 
Additionally, DURAVYU has the most robust safety database among sustained delivery treatments with over 190 patients dosed across multiple indications, with no DURAVYU related ocular or systemic serious adverse events reported. This exceptional safety profile, coupled with the strong efficacy data to date, gives us confidence in the potential for DURAVYU to change the current treatment paradigm for VEGF-mediated retinal diseases.
Our new state-of-the-art commercial manufacturing facility in Northbridge, Massachusetts, is now online. The cGMP facility was built to meet FDA and EMA standards, and it will support global manufacturing for DURAVYU, upon potential regulatory approval. The facility is strategically designed to support our next phase of growth and broadens our manufacturing capabilities with expansion capacity.
Turning to our balance sheet, we remain in a solid financial position. We ended 2024 with $371 million in cash and investments and no debt, enabling us to fund operations into 2027 beyond topline Phase 3 data for DURAVYU in wet AMD. 
We were pleased to make important additions to our Board of Directors with the appointments of Fred Hassan, a distinguished leader and visionary in the industry, and Reginald J. Sanders, M.D., FASRS, a renowned retina specialist and esteemed leader in ophthalmology. Both Mr. Hassan and Dr. Sanders bring extensive industry experience which will be invaluable as we continue to make progress in bringing a potential revolutionary treatment to patients. We also expanded our Scientific Advisory Board, co-chaired by leading key opinion leaders, Carl Regillo M.D., FACS, and Charles Wykoff, M.D., Ph.D., with world-renowned retina specialists: Usha Chakravarthy, M.B.B.S, PhD., Allen Ho, M.D. FACS FASRS and Frank Holz, M.D. These prominent leaders of the retina community will support the continued advancement of our global clinical strategy.

      EyePoint continues to be a story of a potential paradigm-altering treatment with DURAVYU, strong execution, and focused leadership in retinal disease. As a company, we are highly focused on the successful completion of enrollment of our Phase 3 wet AMD clinical trials in the second half of this year with top line data anticipated in 2026. 
We are grateful for the dedicated and talented team at EyePoint who continue to drive our progress and are responsible for our company’s clinical, operational and financial success to date. In addition, we’d like to thank the patients and clinical investigators for their participation in our ongoing trials; without whom, our progress advancing DURAVYU would not be possible. With a world-class leadership team, a clear and well-established regulatory approval pathway in wet AMD, and a strong balance sheet, we are well positioned as the leader in sustained ocular drug delivery. 
On behalf of the entire EyePoint team and Board of Directors, we thank you, our committed stockholders, for your continued support as we continue to execute on our mission to improve the lives of patients with serious retinal diseases – because when it comes to matters of sight, innovation is our vision. 
 
Sincerely,
 
Jay S. Duker, M.D.
President & Chief Executive Officer
 
Göran Ando, M.D.
Chair of the Board

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.

SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this proxy statement 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 identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements in this proxy statement include, but are not limited to, statements regarding the Company’s clinical development and regulatory plans; the Company’s manufacturing capabilities; the Company’s expected timing for availability and release of clinical data; the Company’s expected cash runway; and other statements regarding the Company’s future plans, objectives, strategies and beliefs. 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, this includes uncertainties regarding the timing, progress and results of the company’s clinical development activities, including DURAVYU; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; 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. 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.

SEC Form DEF 14A filed by EyePoint Pharmaceuticals Inc.