EyePoint Pharmaceuticals provides company updates, 2025 milestones for Duravyu

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EyePoint Pharmaceuticals has provided an extensive company update and anticipated 2025 milestones for its lead product candidate Duravyu (vorolanib intravitreal insert), f/k/a EYP-1901. Duravyu is an investigational sustained delivery therapy delivering patent-protected vorolanib, which is a selective tyrosine kinase inhibitor (TKI) formulated in proprietary bioerodible Durasert E intended for sustained intraocular delivery, according to a news release.

“2024 was an exceptional year for EyePoint, positioning us for continued success and execution in 2025,” said Jay Duker, MD, EyePoint president and CEO, in the release. “Most importantly, as we step into 2025, both of our global Phase 3 clinical trials for Duravyu in wet age-related macular degeneration (AMD) are now fully underway with enrollment in both trials exceeding our expectations. The LUGANO trial has already enrolled approximately one-third of planned patients, and the LUCIA trial is tracking ahead of schedule after an accelerated initiation in December. We expect to fully enroll these trials in the second half of 2025. We remain very excited by the large market opportunity for Duravyu in diabetic macular edema (DME) where 16 week interim data demonstrated early and sustained improvement in BCVA and CST. We look forward to final VERONA data and as well as alignment with the FDA and EMA in the coming months to finalize our Phase 3 plan for this important indication.”

For both the LUGANO and LUCIA, topline data is anticipated in 2026. Both the trials are designed to provide data on the efficacy, durability, and safety of Duravyu and to provide the retina community with insight on how it can be used in real-world practice. The Phase 3 pivotal design is the only sustained delivery wet AMD program evaluating 6 month redosing in both trials, with Duravyu being the only sustained release TKI being evaluated in DME, according to the release.

Duravyu was evaluated in patients with DME in a positive interim 16 week Phase 2 VERONA clinical trial, which demonstrated Duravyu 2.7mg improved active DME better than aflibercept alone, both anatomically and visually. This improvement was measured in the 68.1 microns of improvement in central subfield thickeness, with a BCVA gain of +8.9 letters versus baseline. Full topline data from the trial is expected in the first quarter of 2025, with interactions with the FDA and the European Medicines Agency on Phase 3 plans to then follow.

Duravyu was also previously evaluated in the largest Phase 2 clinical trial to date (DAVIO 2) of all sustained delivery programs in development, and met all primary and secondary endpoints. With over 190 patients dosed across multiple indications, there were no related ocular or systemic serious adverse events reported. Additionally, EyePoint’s Duraset technology has been utilized in 4 FDA approved products “with an established favorable safety profile in thousands of patients,” according to the release.

Company updates

EyePoint also had a slew of other corporate updates, running from the end of December 2024 through mid-January 2025. These include the appointment of retina specialist and industry pioneer Reginald J. Sander, MD, FASRS to the company’s Board of Directors, the opening of its cGMP commercial manufacturing facility in October 2024, and an expected $270 million in cash and investments with cash runway into 2027 in 2026.

“We continue our track record of strong execution with the opening of our new, state-of-the-art Northbridge, Massachusetts manufacturing facility in the fall of 2024,” Duker said in the release. “The 40,000 plus square-foot manufacturing facility reflects our commitment to quality and commercial readiness for Duravyu. With 2 simultaneous Phase 3 clinical trials underway, the most robust clinical dataset of all long-acting treatments in development for wet AMD, an impressive patent portfolio for Duravyu, and a strong balance sheet, we are well-positioned to advance our mission of bringing potentially life-changing therapeutics to patients suffering from serious retinal diseases globally.”

Reference:

1. EyePoint provides company update and anticipated development milestones for 2025. News release. EyePoint Pharmaceuticals. January 13, 2025. Accessed January 15, 2025.