EyePoint Pharmaceuticals executives told investors at Morgan Stanley's 24th Annual Global Healthcare Conference on Tuesday, September 15, 2026, that the company sees its DURAVYU program as still having a viable regulatory path. The company's shares closed at $4.25 on September 14, 2026, down 77% year to date, while InvestingPro data showed a current ratio of 4.5.
DURAVYU, a 2.7 mg vorolanib intravitreal insert, is being developed for wet age-related macular degeneration and diabetic macular edema. President and CEO Jay Duker described vorolanib as a small-molecule tyrosine kinase inhibitor with activity against VEGF receptors, PDGF and JAK1. He said the Phase III LUGANO trial supported the insert's safety profile, with no major safety concerns carried over from earlier Phase I and Phase II studies.
LUGANO was entirely U.S.-based and included 75% treatment-naive patients and 25% previously treated patients. In the trial's control arm, 0.5% of patients lost 15 or more letters of vision, compared with a historical expectation of 4% to 5% and 7.7% in the DAVIO 2 Phase II control arm. Nine DURAVYU-treated patients lost 15 or more letters, with six cases linked to geographic atrophy, two to glaucoma and one to post-surgical complications.
Duker emphasized secondary endpoints as central to commercial potential, saying the goal is to improve long-term vision and reduce treatment burden. He said DURAVYU reduced treatment burden by more than 40%, equivalent to about two fewer injections per year on average, while second-generation anti-VEGF products such as high-dose EYLEA and VABYSMO reduce burden by less than 20%, or about one injection per year. He added that 54% of wet AMD patients achieved full-year disease control with DURAVYU alone, and nearly 90% of eyes were controlled with four or fewer injections per year.
CFO George Elston framed DURAVYU as a new mechanism of action that could serve as a foundational therapy, with anti-VEGF biologics used as needed between treatments. He said the company's message was no longer an either/or choice between approaches.
The next key catalyst is the LUCIA Phase III wet AMD study, with top-line data expected in the fourth quarter of 2024. LUCIA is expected to include about 80% U.S. patients and 20% international patients. If the study is positive, EyePoint plans to file a New Drug Application in the first half of 2027.
The company also has two Phase III diabetic macular edema studies, COMO and CAPRI, which are fully enrolled with more than 480 patients combined. Top-line data from those trials is expected in the fourth quarter of 2027, which is also the end of the company's expected cash runway. EyePoint reported cash of about $180 million at the end of the second quarter of 2024.
The DME market is described as a $3 billion market. Real-world first-year treatment is recommended at about 11 injections, but actual practice averages about three injections. In the VERONA Phase II DME study, DURAVYU showed about four letters of better vision than EYLEA (aflibercept) at week 4 and was 40 to 50 microns drier on OCT.
