EYPT EyePoint Pharmaceuticals Inc

 

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): February 05, 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:

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. ☐

 

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Item 8.01 Other Events.

On February 5, 2025, EyePoint Pharmaceuticals, Inc. (the “Company”) issued a press release announcing positive topline results for its ongoing Phase 2 VERONA clinical trial evaluating DURAVYU™ for diabetic macular edema. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.

Additionally, on February 5, 2025, 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 February 5, 2025
99.2		Investor Presentation of EyePoint Pharmaceuticals, Inc. dated February 5, 2025
104		Cover Page Interactive Data File (embedded within the inline XBRL document)

 

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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.

			EYEPOINT PHARMACEUTICALS, INC.
Date:	February 5, 2025	By:	/s/ George O. Elston
			George O. Elston Executive Vice President and Chief Financial Officer

 

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Exhibit 99.1

EyePoint Announces Positive Six-Month Results for the Phase 2 VERONA Clinical Trial of DURAVYUTM for Diabetic Macular Edema Meeting Primary and Secondary Endpoints

- Primary endpoint achieved by both DURAVYU doses (1.34mg and 2.7mg) with extended time to first supplemental injection versus aflibercept control –

- DURAVYU 2.7mg demonstrated an early and sustained improvement in BCVA with a 24-week gain of +7.1 letters and anatomical improvement of 76 microns reduction in CST paired with reduction in treatment burden of two-thirds

– Favorable safety profile continues with no DURAVYU-related ocular or systemic SAEs –

– Phase 3 non-inferiority pivotal program initiation anticipated by the end of 2025 –

– Conference call to be held today, February 5, 2025 at 8:00 a.m. ET –

WATERTOWN, Mass., February 5, 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 positive six-month results for the ongoing Phase 2 VERONA clinical trial evaluating DURAVYU™ (vorolanib intravitreal insert), an investigational sustained delivery therapy delivering patent-protected vorolanib, a selective tyrosine kinase inhibitor (TKI) formulated in proprietary bioerodible Durasert E™. The clinical trial met its primary endpoint with extended time to first supplemental injection compared to aflibercept control for both DURAVYU doses. The trial also demonstrated clinically meaningful outcomes including continued safety with no DURAVYU-related ocular or systemic serious adverse events (SAEs) and an early and sustained improvement in vision and anatomical control. DURAVYU 2.7mg demonstrated a +7.1 letter BCVA gain and 76-micron CST reduction at week 24, with a supplement-free rate of 73% versus 50% for eyes treated with aflibercept. These positive Phase 2 VERONA results add to a robust dataset across another key indication demonstrating the best-in-class potential for DURAVYU in serious retinal diseases.

“We are extremely pleased to report these highly positive VERONA results that demonstrate 2.7mg DURAVYU immediately and meaningfully improves both visual acuity and anatomy in DME patients with a superior dosing interval and excellent safety. This underscores the potential of DURAVYU to be a best-in-class treatment for patients,” said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint. “DME is the leading cause of vision loss in working age adults and the second largest market in retinal diseases after wet age-related macular degeneration (wet AMD). The data from the VERONA trial demonstrate that after a single DURAVYU 2.7mg treatment there was an early and maintained improvement in both BCVA and retinal thickening as measured by OCT throughout the six-month trial, demonstrating the differentiated profile of DURAVYU with immediate bioavailability and zero order kinetics drug delivery. Importantly, the favorable safety and tolerability profile of DURAVYU continued with no DURAVYU-related ocular or systemic serious adverse events. These compelling results support a noninferiority pivotal program in DME, and we plan to meet with the FDA in the second quarter for potential initiation of a Phase 3 clinical trial later in 2025. With ongoing pivotal trials in wet AMD on track to read-out in 2026 and positive efficacy and safety data across multiple Phase 2 clinical trials, DURAVYU is well-positioned to become a potential blockbuster franchise.”

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Phase 2 VERONA results as of January 16, 2025 data cut-off include:

 

“DME is a prevalent disease with a significant need for more durable treatments,” said Ramiro Ribeiro, M.D., Ph.D., Chief Medical Officer. “The data from the Phase 2 VERONA trial demonstrated that within four weeks, eyes treated with DURAVYU had a significant benefit for patients with DME, both visually and anatomically. The magnitude of these results gives us confidence moving forward into a Phase 3 noninferiority program with a differentiated treatment for patients with DME who need effective, safe and durable treatment options. We would like to thank the patients, investigators and their staff for participating in the trial, and we look forward to working with regulatory agencies to discuss next steps as we work to advance this innovative therapy and improve the lives of patients suffering from serious retinal diseases.”

“The diabetes epidemic and the associated increase in patients with DME has resulted in a significant burden to patients and the healthcare system,” said Carl Regillo, M.D., FACS, Chief of Retina Service at Wills Eye Hospital and Co-Chair of EyePoint’s SAB. “The number of diabetic retinopathy patients is predicted to reach 16 million by 2050, and diabetes-related vision loss is expected to cost 500 million US dollars annually. The average patient with DME is working age and requires burdensome monthly injections that can result in missed visits and chronic undertreatment. This can lead to irreparable vision loss and potential blindness. I am very encouraged by the Phase 2 VERONA data demonstrating the ability to improve vision and anatomy while maintaining a favorable safety and tolerability profile. Additionally, DURAVYU features zero order kinetics release, so the VEGF receptors remain blocked for at least six months enabling the ability to extend dosing intervals while maintaining the patient’s vision. This feature will be important in the DME population, giving patients and physicians a durable treatment option. Based on these meaningful Phase 2 results, I believe DURAVYU demonstrates the ability to

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fundamentally alter the treatment paradigm in DME, and if approved, has the potential for significant adoption among retina specialists.”

VERONA is a randomized, controlled, single-masked, open label Phase 2 trial of DURAVYU in DME patients previously treated with a standard-of-care anti-VEGF therapy. The trial enrolled 27 patients assigned to one of two intravitreal doses of DURAVYU (1.34mg or 2.7mg) or aflibercept control. The primary efficacy endpoint of the VERONA trial is time to first supplemental aflibercept injection up to 24 weeks based on established supplement criteria. Key secondary endpoints include safety, mean change in best corrected visual acuity (BCVA), mean change in central subfield thickness (CST) as measured by optical coherence tomography (OCT) and change in diabetic retinopathy severity scale (DRSS) over time. More information about the trial is available at clinicaltrials.gov (identifier: NCT06099184).

The 16-week interim data will be presented at Angiogenesis, Exudation, and Degeneration 2025 in February and the full six-month data at an upcoming medical meeting.

About Diabetic Macular Edema

Diabetic macular edema (DME) is the leading cause of vision loss in people with type 1 and type 2 diabetes. DME results when damaged blood vessels leak fluid into the macula, the central portion of the retina responsible for the sharp vision needed for routine tasks such as driving or reading. This resulting retinal swelling can cause blurred vision and may lead to severe vision loss or even blindness. DME is a common form of sight-threatening retinopathy in people with diabetes, with approximately 28 million people afflicted worldwide. As the prevalence of diabetes continues to grow, an increased number of people will be affected by diabetic eye diseases such as DME. The current standard of care for patients experiencing DME includes intravitreal injections of short-acting anti-VEGF biologics, corticosteroids, or laser photocoagulation which can become a burden on patients, caregivers, and physicians due to the longevity of the disease.

About DURAVYU™

DURAVYUTM, 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 actively enrolling in two ongoing global Phase 3 clinical trials, LUGANO and LUCIA, in wet AMD. The pivotal programs are evaluating re-dosing of DURAVYU compared to non-inferiority with standard-of-care, with the goal of providing the retina community valuable insight into ‘real-world’ usage of DURAVYU.

DURAVYU is also currently being studied for the treatment of diabetic macular edema (DME). The Phase 2 VERONA trial met the primary endpoint and demonstrated an immediate and sustained improvement in vision and anatomy, a continued favorable safety and tolerability profile with superior

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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 is anticipated to be initiated by the end of 2025.

About EyePoint

EyePoint (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 (wet AMD), the leading cause of vision loss among people 50 years of age and older in the United States, and in a Phase 2 clinical trial in diabetic macular edema (DME). Based on positive Phase 2 results from the VERONA clinical trial in DME, EyePoint anticipates initiation of a Phase 3 pivotal program by the end of 2025 with topline data from both Phase 3 pivotal trials in wet AMD in 2026.

Pipeline programs include EYP-2301, a TIE-2 agonist, razuprotafib, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases. 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 Pharmaceuticals is headquartered in Watertown, 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 PHARMACEUTICALS 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 the timing and clinical development and potential of DURAVYU in DME and wet AMD, including our expectations regarding the VERONA trial following our announcement of full topline data and the progress of our ongoing LUGANO and LUCIA trials; our beliefs and expectations that the full topline results from the VERONA trial support DURAVYU’s potential to advance to non-inferiority pivotal trials; the potential for DURAVYU 2.7mg to extend treatment intervals while improving vision without sacrificing anatomy; the potential for DURAVYU to provide an immediate benefit over aflibercept control in both BCVA and CST; our optimism that that DURAVYU has the potential to shift the treatment paradigm in DME and improve patient outcomes; our expectations regarding clinical development of our other product candidates, including EYP-2301; our business strategies and objectives; and other 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 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

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company’s clinical development activities; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; 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; 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.

Investors:

Christina Tartaglia
Precision AQ (formerly Stern IR)

Direct: 212-698-8700
christina.tartaglia@sternir.com 

 

Media Contact:

Amy Phillips

Green Room Communications

Direct: 412-327-9499

aphillips@greenroompr.com

 

 

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

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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 the timing and clinical development of DURAVYU™ in Wet AMD and DME, our expectations regarding the enrollment, dosing and data readouts for the LUGANO trial and the LUCIA trial; our expectations regarding the VERONA trial following our announcement of full topline data; our optimism that 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; 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; uncertainties and delays relating to the design, enrollment, completion, and results of clinical trials; 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; 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, 2023, 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.

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EyePoint: The Leader in Sustained Release Drug Delivery for Retinal Disease ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Most robust dataset in wet AMD and DME among all sustained delivery programs in development Two ongoing global Phase 3 non-inferiority pivotal trials in wet AMD Strong balance sheet with ~$370M in cash and equivalents1; cash runway into 2027 DURAVYU™: patent protected vorolanib featuring new MOA delivered via best-in-class IVT delivery technology, Durasert E™ Only sustained release TKI with active program in DME bolstered by highly positive Phase 2 clinical data 1. As of December 31, 2024. Unaudited estimate, inclusive of net proceeds from October 2024 equity financing. MOA, mechanism of action; wet AMD, wet age-related macular degeneration; DME, diabetic macular edema 1 2 3 4 5

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©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 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 Enrollment completion in 2H 2025 FDA mtg expected in 2Q 2025 Pre-clin tox and PK data PIVOTAL TRIALS UNDERWAY Positive Six-Month Data Evaluating additional pipeline opportunities

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IVT, intravitreal DURASERT E™ TECHNOLOGY Sustained-Release Drug Delivery Standard in-office IVT injection Continuous dosing Zero-order kinetics drug release Bioerodible Durasert E™: Solid injectable insert Drug formulated within a bioerodible matrix Designed to release drug load before matrix fully erodes Favorable safety profile across multiple indications ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Insert is 1/5000 of Vitreous Volume​

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©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 1. Bakri SJ, et al. PLoS One. 2024;19(6):e0304782 [CC BY 4.0]. TKI tyrosine kinase inhibitor; AMD, age-related macular degeneration; Ang, angiopoietin; FGF(R), fibroblast growth factor (receptor); PDGF(R), platelet-derived growth factor (receptor); PLGF, placental growth factor; TKI, tyrosine kinase inhibitor; TIE2, tyrosine-protein kinase receptor TIE-2; VEGF(R), vascular endothelial growth factor (receptor); VE-PTP, vascular endothelial cell-specific protein tyrosine phosphatase. Vorolanib is a Best-In-Class TKI that Selectively Inhibits all Forms of the VEGF Receptor Potent and highly selective pan-VEGF receptor inhibitor Composition of matter patent into 2037 Acts intracellularly to preventpro-angiogenic signaling Demonstrated neuroprotection Potential antifibrotic Does not inhibit TIE21 Endothelial cell VEGFB VEGFA VEGFC VEGFD VEGFR1 VEGFR2 VEGFR3 TIE2 PDGFR ANG1 ANG2 PDGF Angiogenesis, permeability, leakage, growth, migration, and proliferation Blood vessel stability Proliferation, motility PLGF Pericyte VOROLANIB Pathological angiogenesis and vascular instability underlie wet AMD

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©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Immediately bioavailable – reaches therapeutic levels within hours Constant dosing – zero-order kinetics release for at least six months Controlled drug release – bioerodible matrix controls drug release; no free-floating drug Contains NO PEG or PLGA Preloaded sterile syringe injector Shipped and stored at ambient temperature DURAVYU: Vorolanib in Bioerodible Durasert E™ DURAVYU™ Bioerodible Insert 94% drug 1/5000 of vitreous volume

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©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. DURAVYU Demonstrated Positive Efficacy and Favorable Safety Profile Across Multiple Clinical Trials and Indications 1. Data as of January 16, 2025. Preliminary data pending final analysis. Wet AMD, wet age-related macular degeneration; NPDR, non-proliferative diabetic retinopathy; DME, diabetic macular edema; SAEs, serious adverse events; BCVA, best-correct visual acuity; OCT, optical coherence tomography. Clinical Trial Indication Safety Key Efficacy Outcomes DAVIO wet AMD No DURAVYU related ocular or systemic SAEs Stable BCVA and CST 74% reduction in treatment burden DAVIO 2 wet AMD Statistically non-inferior BCVA vs on-label aflibercept >80% reduction in treatment burden Stable anatomy (CST) PAVIA NPDR Stable or prevention of worsening disease severity VERONA1 DME Primary endpoint met Meaningful, immediate and sustained improvement in BCVA and OCT DURAVYU Has Been Evaluated in Over 190 Patients to Date Across Multiple Indications

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©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Phase 2 VERONA Clinical Trial in DME – Six-Month Results Immediate Bioavailability and sustained delivery for At Least Six months DME, diabetic macular edema Data as of January 16, 2025. Preliminary data pending final analysis.

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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 market by 20303 Delayed/missed treatment visits4 54.9M 25% up to 51% $3.9B 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

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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) Primary endpoint -D28 to -D7 D1 W4 W8 W12 W16 W20 W24 Phase 2 VERONA Clinical Trial is a Randomized, Open-Label, Aflibercept Controlled Trial as a Potential Treatment for DME

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VERONA Clinical Trial Supplement Criteria ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 1. vs. best on study measurement; 2. as measured by Spectral domain OCT (SD-OCT) BCVA, best corrected visual acuity; PRN, pro re nata; CST, central subfield thickness Starting at Week 4: Reduction in BCVA ≥10 letters due to DME1 Reduction in BCVA of 5-9 letters and >75 microns of new fluid at two consecutive visits1 Increase of ≥100 microns of new fluid vs. Baseline (Day 1)2 Investigator discretion Starting at Week 12 (unique supplementation criteria incorporated due to PRN design of trial): Lack of 10% reduction in CST compared to Baseline (Day 1)

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VERONA:Phase 2 Clinical Trial Met Primary and 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 - 24 WEEK EFFICACY Results: 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 73% supplement-free eyes vs. 50% aflibercept control ~Two-thirds reduction in treatment burden DURAVYU SAFETY Results: No ocular or systemic DURAVYU-related 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. Data as of January 16, 2025. Preliminary data pending final analysis.

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©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. VERONA: Single DURAVYU 2.7mg Treatment Demonstrated Clinically Meaningful Improvement in BCVA; Supports Noninferiority in Pivotal Trial BCVA, best-corrected visual acuity; VA, visual acuity Data as of January 16, 2025. Preliminary data pending final analysis. 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. VERONA: DURAVYU 2.7mg Demonstrated Improved and Controlled Anatomy with 74% More Drying than Aflibercept Control CST: central subfield thickness Data as of January 16, 2025. Preliminary data pending final analysis. 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 DURAVYU 2.7mg -32.2 um -71.1 um

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VERONA: Eyes Treated with DURAVYU had a Greater Proportion of Supplement-Free Eyes vs. Aflibercept Control up to Six Months ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Data as of January 16, 2025. Preliminary data pending final analysis. 2.7mg DURAVYU reduced treatment burden by over two-thirds Summary of Cumulative Supplement-Free Rates 100% 100% 100% 100%

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Phase 2 VERONA Clinical Trial Case Study 1 - 2.7mg Dose Pt - Immediate Drying with Improved Vision After Single DURAVYU Treatment and No Supplementation- Prior treatment = 2x Eylea, 1x Vabysmo in past 12 months ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Day 1 BCVA: 46 Week 4 BCVA: 65 Week 16 BCVA: 67 Week 24 BCVA: 66

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Phase 2 VERONA Clinical Trial Case Study 2 - 2.7mg Dose Patient- Continued Drying at Week 24 with Improved VA After Single DURAVYU Treatment and No Supplementation - Prior treatment = 1x Avastin, 5x Vabysmo in past 7 months ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Day 1 BCVA: 73 Week 4 BCVA: 74 Week 16 BCVA: 80 Week 24 BCVA: 80

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Continued Favorable Safety and Tolerability Profile in VERONA Clinical Trial ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. SAE, serious adverse event Data as of January 16, 2025. Preliminary data pending final analysis. No reported DURAVYU-related ocular SAEs or systemic SAEs No cases of: Endophthalmitis Retinal vasculitis (occlusive or non-occlusive) Insert migration Intraocular inflammation (IOI) No discontinuations >190 patients treated with DURAVYU to date with no DURAVYU-related SAEs

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VERONA: Phase 2 Clinical Trial Highlights ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Data as of January 16, 2025. Preliminary data pending final analysis. Primary endpoint met for both DURAVYU doses Demonstrated immediate clinical bioavailability Achieved clinically meaningful results without a full load of aflibercept Significant improvement in vision paired with a meaningful reduction in treatment burden Significantly better anatomic results with fewer supplemental injections Continued favorable safety and tolerability

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Positive Phase 2 VERONA Data Supports Advancement to Phase 3 Pivotal Program – Expected Initiation by End of 2025 ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Next Steps: Continue development of Phase 3 clinical protocol – non-inferiority design Discuss Phase 2 results and proposed Phase 3 clinical protocol with regulatory agencies (FDA, EMA) Initiation of pivotal program anticipated by the end of 2025 leveraging the experience from LUGANO and LUCIA wet AMD trials Present results at future medical conferences

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

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Phase 3 Trials are Designed to Enable Global Regulatory Approvals for DURAVYU ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Demonstrate DURAVYU, when administered every six months, achieves similar visual outcomes to on-label aflibercept while reducing treatment burden ~400 patients per trial Two arms 2.7mg DURAVYU aflibercept on-label control DURAVYU dosing every 6-months One-year efficacy and safety endpoint for NDA submission Primary Endpoint: difference in mean change in BCVA from Day 1 to Week 52 and 56 (blended) versus aflibercept control Secondary endpoints: safety, reduction in treatment burden, percent of eyes supplement-free, anatomical stability LUGANO and LUCIA Trials: global, randomized, double-masked, aflibercept controlled Objective Trial Design Endpoints

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DURAVYU™ in Wet AMD Phase 3 Pivotal Trial Design ©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/LUCIA First Patient Dosed Topline Data in 2026

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Exceptional Enrollment to Date Driven by Significant Investigator and Patient Enthusiasm ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. June 2024 Final Phase 3 protocols October 2024 First patient in LUGANO trial dosed December 2024 First patient in LUCIA trial dosed 2H 2025 Expected full enrollment of both Phase 3 pivotal trials Top line data for both Phase 3 pivotal trials anticipated in 2026 January 2025 LUGANO trial ~1/3 enrolled; LUCIA exceeding expectations 2026 Topline data for pivotal program

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Commercial Manufacturing Facility Opened in October 2024 ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 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 40,000sf cGMP manufacturing facility Built to EYPT specifications by landlord preserving upfront cash investment New manufacturing site for commercial production of DURAVYU

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©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. EYP-2301: razuprotafib in Durasert E™ A sustained delivery tie-2 agonist for severe retinal diseases

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EYP-2301: Razuprotafib in Durasert E™ is a Patented TIE-2 Agonist as a Potential New MOA for Treating Serious Retinal Diseases ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. 1. Heier et al. Retina, 2021;41:1-19. and Joussen et al. Eye 2021; 35:1305-1316.; 2. Hammes, et. Al – Diabetes.2011 Jan 1; 3. Shen et al. JCI, 2014; 124:4564; 3. Campochiaro et al. Ophthalmology, 2016; 123:1722-1730; 4. Phase 2 TIME 2a clinical trial conducted by Aerpio. 5.Campochiaro et al. PubMed 2016 123(8):1722-1730. DOI: 10.1016/j.ophtha.2016.04.025 EYP-2301 targets vascular endothelial protein tyrosine phosphatase (VE-PTP) activating TIE-2 and downregulating ANG2 to maintain vascular stability in the retina P P EYP-2301 Blood vessel lumen Intracellular space VE-PTP ANG2 Tie-2 activation combined with VEGF inhibition has the potential to enhance efficacy and extend durability1 of treatment Razuprotafib (f/k/a AKB-9778) delivered subcutaneously demonstrated preclinical and clinical proof of concept in posterior segment disease 2,3 In a Phase 2 clinical trial, razuprotafib combined with ranibizumab, was more effective than ranibizumab alone at reducing macular edema with a favorable safety and tolerability profile4,5

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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 ✓ Positive EOP2 meeting with FDA for wet AMD April 2024 ✓ PAVIA for NPDR topline data May 2024 ✓ DAVIO 2 12-month data Jue 2024 ✓ Positive interim VERONA data October 2024 ✓ First patient dosed – LUGANO October 2024 ✓ First patient dosed – LUCIA December 2024 ✓ VERONA Phase 2 DME full topline data February 2025 FDA meeting for DME Q2 2025 Anticipated initiation of Phase 3 pivotal program for DME By end of 2025 ✓ Expanded SAB with world-renowned retina specialists April 2024 ✓ 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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EyePoint: The Leader in Sustained Release Drug Delivery for Retinal Disease ©2025 EyePoint Pharmaceuticals, Inc. All Rights Reserved. Most robust dataset in wet AMD and DME among all sustained delivery programs in development Two ongoing global Phase 3 non-inferiority pivotal trials in wet AMD Strong balance sheet with ~$370M in cash and equivalents1; cash runway into 2027 DURAVYU™: patent protected vorolanib featuring new MOA delivered via best-in-class IVT delivery technology, Durasert E™ Only sustained release TKI with active program in DME bolstered by highly positive Phase 2 clinical data 1. As of December 31, 2024. Unaudited estimate, inclusive of net proceeds from October 2024 equity financing. MOA, mechanism of action; wet AMD, wet age-related macular degeneration; DME, diabetic macular edema 1 2 3 4 5

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

v3.25.0.1

Document And Entity Information	Feb. 05, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Feb. 05, 2025
Entity Registrant Name	EyePoint Pharmaceuticals, Inc.
Entity Central Index Key	0001314102
Entity Emerging Growth Company	false
Entity File Number	000-51122
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	26-2774444
Entity Address, Address Line One	480 Pleasant Street
Entity Address, City or Town	Watertown
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02472
City Area Code	(617)
Local Phone Number	926-5000
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001
Trading Symbol	EYPT
Security Exchange Name	NASDAQ

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