EyePoint (Nasdaq: EYPT) Reports Corporate Update and Anticipated Pivotal Milestones for 2026

WATERTOWN, Mass., Jan. 07, 2026 (GLOBE NEWSWIRE) - EyePoint, Inc. (Nasdaq: EYPT) has announced significant developments regarding its lead product candidate, DURAVYU™ (vorolanib intravitreal insert). The company is progressing with its Phase 3 programs for DURAVYU targeting wet age-related macular degeneration (AMD) and diabetic macular edema (DME), which are some of the largest multi-billion-dollar retinal disease markets. This update outlines key milestones expected in 2026, focusing on the company's achievements and future plans.

Key Milestones and Upcoming Events

• Phase 3 trials for wet AMD are on track for data readout beginning mid-2026.
• First patient dosing in the Phase 3 DME program is expected in Q1 2026.
• EyePoint will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026, at 7:30 a.m. PT.

Corporate Update from the CEO

Dr. Jay S. Duker, President and CEO, stated, “Following an incredibly successful year of execution in 2025, EyePoint is positioned to deliver on key priorities across both our late-stage programs in 2026.” He emphasized the company's commitment to scientific rigor and a patient-centric focus. Dr. Duker further noted that the topline data from the Phase 3 wet AMD program is expected in mid-2026, and that the company is preparing for a swift NDA filing and subsequent FDA review of DURAVYU.

OVERVIEW: DURAVYU in Wet AMD

EyePoint has completed enrollment of over 900 patients for the Phase 3 LUGANO and LUCIA trials in just seven months. This rapid enrollment positions DURAVYU to potentially be the first market entrant among current investigational sustained delivery programs.

• LUGANO randomized 432 patients in the U.S. with topline data anticipated in mid-2026.
• LUCIA randomized 475 patients across the U.S. and additional international sites.
• The trials are designed as identical, double-masked noninferiority studies with aflibercept as the control.

Clinical Data and Regulatory Progress

The primary endpoint of the Phase 3 wet AMD program focuses on noninferiority in visual acuity change at 52 and 56 weeks compared to aflibercept. Secondary endpoints examine safety, treatment burden reduction, and anatomical improvements. Interim data through September 29, 2025, indicate a consistent safety profile with the previous DURAVYU clinical studies, and an independent Data Safety Monitoring Committee has recommended continuation of the program.

DURAVYU registration batches are ongoing at EyePoint’s commercial manufacturing facility in Northbridge, Massachusetts, to support the chemistry, manufacturing, and controls for the NDA filing.

DURAVYU in Diabetic Macular Edema (DME)

In alignment with FDA and EMA guidelines, the pivotal DME program is on track, with first patient dosing expected in Q1 2026. The COMO and CAPRI trials will each enroll approximately 240 patients, randomly assigning them to either the DURAVYU 2.7mg arm (with six-month redosing) or the 2mg aflibercept control.

Positive Data Presentations and Conference Involvement

DURAVYU's multi-mechanism action has been discussed in various presentations, including a 50% reduction in IL-6 activity associated with DURAVYU treatment. Additionally, positive results from the Phase 2 VERONA trial demonstrated significant visual and anatomical improvements compared to aflibercept.

EyePoint will present updates on DURAVYU for retinal exudative diseases at the Hawaiian Eye and Retina 2026 conference, highlighting the compound's potential in treating serious retinal illnesses.

Financial Overview and Future Outlook

In October 2025, EyePoint completed an underwritten public offering that raised $172.5 million. The company reported approximately $300 million in cash and investments as of December 31, 2025, providing a cash runway into Q4 2027. This funding will support critical milestones in the ongoing Phase 3 wet AMD program and further promote the DME program.

EyePoint maintains a strong position in the retinal disease market, with DURAVYU potentially becoming a leading treatment option for both wet AMD and DME.

About DURAVYU™

DURAVYU™ (vorolanib intravitreal insert) is an investigational sustained-delivery treatment aimed at serious retinal diseases. It promises prolonged release of therapeutic doses through an innovative delivery system, thereby addressing market needs.