August 07, 2025
2 min watch
Key takeaways:
- More than 400 patients have been enrolled in the LUCIA trial investigating Duravyu.
- EyePoint expects topline data from its phase 3 pivotal program in 2026.
LONG BEACH, Calif. — EyePoint Pharmaceuticals completed enrollment in the LUCIA trial, its second phase 3 trial of Duravyu in patients with wet age-related macular degeneration, according to a press release.
More than 400 patients have been enrolled in the trial and undergone randomization over the past 7 months. EyePoint’s first phase 3 trial of Duravyu, LUGANO, completed enrollment in May.
Both trials will assess the efficacy and safety of sustained-release Duravyu (vorolanib intravitreal insert) in patients with wet AMD who have been randomly assigned to receive either Duravyu 2.7 mg or on-label aflibercept control.
“These diseases are currently treated with short-acting ligand blockers, which do a very good job in the short term, but the big unmet need is prevention of visual loss in the long term,” Jay S. Duker, MD, president and CEO of EyePoint, told Healio at the American Society of Retina Specialists meeting.
Patients in the treatment arms receive an intravitreal dose of Duravyu every 6 months starting at month 2. The primary endpoint of the trials is the average change in best corrected visual acuity at 52 weeks and 56 weeks compared with baseline. Secondary endpoints include safety, reduction in treatment burden, percentage of eyes not receiving supplemental aflibercept injections and anatomical results, according to the release.
Interim data from the trials show a safety profile that is consistent with previous clinical trials of Duravyu.
Duker said that with phase 3 enrollment complete, EyePoint expects to have topline data from LUGANO in summer 2026, with data from LUCIA following shortly after.
“We believe we are in position to be the first to file of all the current under investigation sustained-release therapies for wet AMD and hopefully, with approval, first to market,” he said.
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