EyePoint Pharmaceuticals is making strides in the development of DURAVYU™ (vorolanib intravitreal insert), an investigational sustained delivery therapy for VEGF-mediated retinal diseases. The company anticipates key milestones in 2025, including full data from the Phase 2 VERONA trial in diabetic macular edema (DME) and continued progress in Phase 3 trials for wet age-related macular degeneration (AMD).
Advancing DURAVYU in Wet AMD
Enrollment in the global Phase 3 LUGANO and LUCIA trials for DURAVYU in wet AMD is exceeding expectations. The LUGANO trial has already enrolled approximately one-third of planned patients, while the LUCIA trial is tracking ahead of schedule after an accelerated initiation in December. EyePoint expects to complete enrollment in both trials in the second half of 2025, with topline data anticipated in 2026. These trials are designed to evaluate the efficacy, durability, and safety of DURAVYU with a six-month re-dosing regimen, providing valuable insight into its potential use in real-world clinical practice.
VERONA Trial and DME Opportunity
DURAVYU is also being studied in the Phase 2 VERONA trial for diabetic macular edema (DME). Interim 16-week data demonstrated that DURAVYU 2.7mg meaningfully improved patients with active DME compared to aflibercept alone, both anatomically and visually. Patients treated with DURAVYU 2.7mg showed a CST (central subfield thickness) improvement of 68.1 microns and a BCVA (best-corrected visual acuity) gain of +8.9 letters vs. baseline. Full topline data from the VERONA trial is expected in the first quarter of 2025, followed by discussions with the FDA and EMA to finalize Phase 3 plans for DME.
Corporate and Manufacturing Updates
EyePoint has appointed Reginald J. Sanders, M.D., FASRS, a renowned retina specialist, to its Board of Directors. In October 2024, the company opened a new cGMP commercial manufacturing facility in Northbridge, MA, designed to meet U.S. FDA and EMA standards. This facility will support global manufacturing across EyePoint’s portfolio, including DURAVYU, upon potential regulatory approval.
With approximately $370 million in cash and investments as of December 31, 2024, EyePoint's financial runway extends into 2027, beyond the expected topline Phase 3 data for DURAVYU in wet AMD in 2026. Jay Duker, M.D., President and Chief Executive Officer of EyePoint, stated that 2024 was an exceptional year for the company, positioning it for continued success in 2025. He highlighted the large market opportunity for DURAVYU in DME, citing the early and sustained improvements in BCVA and CST observed in the 16-week interim data from the VERONA trial.
