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EyePoint Pharmaceuticals Announces Upcoming Data Presentations at 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting

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EyePoint Pharmaceuticals (NASDAQ: EYPT) has announced positive scientific findings to be presented at the 2023 ARVO Annual Meeting. Key highlights include the neuroprotective effect of vorolanib in EYP-1901, demonstrating potential against retinal degeneration in a validated model. Additionally, findings from the CALM registry indicate effective control of inflammation in chronic posterior segment uveitis using YUTIQ. Presentations will cover preclinical data and clinical outcomes, including the Phase 1 DAVIO trial results showing a significant reduction in the need for anti-VEGF injections. The meeting takes place from April 23-27, 2023, in New Orleans.

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- Positive neuroprotective effect of vorolanib, the active drug in EYP-1901, in a widely validated retinal detachment model demonstrates a potential new mechanism of action for the treatment of retinal disease -

- Clinical outcomes from real-world CALM registry study of YUTIQ® demonstrates effective control of inflammation in chronic posterior segment uveitis -

WATERTOWN, Mass., March 20, 2023 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced multiple scientific presentations at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, being held April 23 – 27 in New Orleans, Louisiana.

“We are excited to be presenting these positive data in support of EYP-1901 and YUTIQ at this year’s ARVO Annual Meeting,” said Jay Duker, M.D., President and Chief Operating Officer of EyePoint Pharmaceuticals. “We are particularly enthusiastic about the compelling preclinical data that highlights the potential neuroprotective effect of vorolanib, the active drug in EYP-1901, against photoreceptor degeneration in a validated retinal detachment model. These preclinical data on vorolanib bring an additional perspective to our positive Phase 1 DAVIO 12-month results, which will be showcased in an encore presentation at the meeting.”

Dr. Duker added, “The preclinical data derived from a widely validated model of retinal detachment highlights vorolanib’s potential new mechanism of action for treating retinal diseases, and its unique benefits that set it apart from existing ligand binding biologics.”  “These preclinical data demonstrate that vorolanib significantly reduced the severity of change in baseline visual acuity and improved contrast thresholds in mice treated with vorolanib compared with placebo, suggesting a neuroprotective effect against photoreceptor degeneration. Should this be reflected in clinical data, it would provide an important new mechanism of action for the treatment of these chronic, blinding retinal eye diseases such as wet AMD, diabetic retinopathy, diabetic macular edema and retinal vein occlusion. In addition, we will present important registry study data that demonstrates YUTIQ’s effective control of inflammation in real-world patients living with chronic posterior segment uveitis.”

Presentation details are as follows:

Presentation Title: Neuroprotective Effect of Tyrosine Kinase Inhibitor Vorolanib in a Mouse Model of Retinal Detachment
Session Title: Retina/RPE: New Drugs, Delivery and Mechanisms of Action 2
Date and Time: Tuesday, April 25, 2023 at 11:45 a.m. to 1:30 p.m. CT / 12:45 to 2:30 p.m. ET
Presenter: Michelle Howard-Sparks, Ph.D., Vice President, Product Development at EyePoint Pharmaceuticals
Presentation Type/Number: Paper Session #2829

Presentation Title: The DAVIO Trial: A Phase 1, Open-Label, Dose-Escalation Study of a Single Injection of EYP-1901 (Vorolanib in Durasert® Platform) Demonstrating Reduced Treatment Burden in Wet Age-Related Macular Degeneration
Session Title: AMD: New Drugs, Delivery Systems and Mechanisms of Action 1
Date and Time: Sunday, April 23, 2023 at 3:45 to 5:30 p.m. CT / 4:45 to 6:30 p.m. ET
Presenter: Ashkan Abbey, M.D., Director of Clinical Research at Texas Retina Associates – Dallas and Clinical Assistant Professor of Ophthalmology at UT Southwestern Medical Center
Presentation Type/Number: Paper Session #931

Presentation Title: CALM: 12-month Results from a Real-World Registry to Characterize Clinical Outcomes for Patients with Chronic Non-Infectious Posterior Segment Uveitis Treated with a 0.18 Mg Fluocinolone Acetonide Intravitreal Insert
Session Title: Uveitis Therapeutics: Current State of the Art and Future Directions
Date and Time: Thursday, April 27, 2023 from 10:30 a.m. to 12:15 p.m. CT / 11:30 a.m. to 1:15 p.m. ET
Presenter: Stephen Anesi, M.D., Partner at Massachusetts Eye Research and Surgery Institution
Presentation Type/Number: Paper Session #5097

Presentation Title: CALM: A Retrospective Registry to Characterize Clinical Outcomes for Chronic Non-Infectious Posterior Segment Uveitis Patients Treated with the 0.18 Mg Fluocinolone Acetonide Intravitreal insert: Intraocular Pressure and Safety Data Analysis
Session Title: Advances in Ocular Inflammatory Disease Therapy
Date and Time: Tuesday, April 25, 2023 from 3:30 to 5:15 p.m. CT / 4:30 to 6:15 p.m. ET
Presenter: Kanika Seth, Research Fellow at Cleveland Clinic Cole Eye Institute
Presentation Type/Number: Poster Session #B0394

Presentation Title: CALM: A Retrospective Registry to Characterize Clinical Outcomes for Chronic Non-Infectious Posterior Segment Uveitis Patients Treated with the 0.18 Mg Fluocinolone Acetonide Intravitreal Implant: Retinal Anatomical Outcomes
Session Title: Advances in Ocular Inflammatory Disease Therapy
Date and Time: Tuesday, April 25, 2023 from 3:30 to 5:15 p.m. CT / 4:30 to 6:15 p.m. ET
Presenter: Alison Zhao, Researcher at Cleveland Clinic Lerner College of Medicine, Case Western Reserve University
Presentation Type/Number: Poster Session #B0402

The abstracts are now available online on the 2023 ARVO Annual Meeting conference website at https://www.arvo.org/annual-meeting/.

About EYP-1901

EYP-1901 is being developed as an investigational sustained delivery treatment combining a bioerodible formulation of EyePoint's proprietary Durasert® delivery technology with vorolanib, a tyrosine kinase inhibitor. Positive safety and efficacy data from the DAVIO Phase 1 clinical trial of EYP-1901 showed no reports of ocular or drug-related systemic serious adverse events and no dose limiting toxicities with stable visual acuity and OCT. Further, 53% and 35% of eyes did not require any supplemental anti-VEGF injections up to six and twelve months, respectively, following a single dose of EYP-1901. Phase 2 studies are underway for wet AMD and non-proliferative diabetic retinopathy and are planned for diabetic macular edema in 2023. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases.

About EyePoint Pharmaceuticals

EyePoint Pharmaceuticals (Nasdaq: EYPT) is a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert® technology for sustained intraocular drug delivery including EYP-1901, an investigational sustained delivery intravitreal anti-VEGF treatment currently in Phase 2 clinical trials. The proven Durasert drug delivery platform has been safely administered to thousands of patients' eyes across four U.S. FDA approved products, including YUTIQ® for the treatment of posterior segment uveitis, which is currently marketed by the Company. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.

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 the use of proceeds for the offering 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, this includes uncertainties regarding the timing and clinical development of our product candidates, including EYP-1901; the potential for EYP-1901 as a novel sustained delivery treatment for serious eye diseases, including wet age-related macular degeneration and non-proliferative diabetic retinopathy; the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the success of current and future license agreements; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; effects of competition and other developments affecting sales of our commercialized products, YUTIQ® and DEXYCU®; the loss of pass-through reimbursement status for DEXYCU as of January 1, 2023; market acceptance of our products; product liability; industry consolidation; compliance with environmental laws; risks and costs of international business operations; volatility of stock price; possible dilution; absence of dividends; the potential impact of the COVID-19 pandemic on EyePoint's business, the medical community and the global economy and the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; manufacturing risks; 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:
Anne Marie Fields
Stern IR
Direct: 332-213-1956
annemarie.fields@sternir.com

Media Contact:
Amy Phillips
Green Room Communications
Direct: 412-327-9499
aphillips@greenroompr.com


FAQ

What are the recent findings regarding EYPT's EYP-1901?

Recent findings indicate that EYP-1901 shows a positive neuroprotective effect in retinal disease models, suggesting a new mechanism of action for treatment.

When will EyePoint Pharmaceuticals present its findings at ARVO 2023?

EyePoint Pharmaceuticals will present its findings at the ARVO Annual Meeting from April 23 to April 27, 2023, in New Orleans.

What does the CALM registry study reveal about YUTIQ?

The CALM registry study demonstrates that YUTIQ effectively controls inflammation in patients with chronic posterior segment uveitis.

What are the implications of the Phase 1 DAVIO trial for EYPT?

The Phase 1 DAVIO trial shows promising results, with many patients not requiring additional anti-VEGF injections up to 12 months after a single dose of EYP-1901.

What is vorolanib's role in EyePoint's treatment strategy?

Vorolanib is the active drug in EYP-1901, and its neuroprotective capabilities could provide a novel treatment pathway for chronic retinal diseases.

EyePoint Pharmaceuticals, Inc.

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