Summary: development and regulatory status as of September 2026

Vorolanib intravitreal insert (DURAVYU, EYP-1901) is an investigational product and is not approved by the FDA. Two identical phase 3 non-inferiority trials compared vorolanib intravitreal insert 2.7 mg every 6 months with aflibercept 2 mg every 8 weeks: LUGANO enrolled 432 participants and LUCIA enrolled 475 participants. On August 17, 2026, EyePoint reported that LUGANO did not meet its primary endpoint (mean change in best-corrected visual acuity, blended weeks 52 and 56) in the full dataset. In an ad hoc analysis that excluded 9 of 211 participants (4%) in the vorolanib insert arm who lost 15 or more letters from causes the sponsor attributed to conditions other than wet AMD, the sponsor reported non-inferiority with a nominal p-value of 0.0096. LUCIA topline data are expected in the fourth quarter of 2026. The sponsor plans a pre-NDA meeting in the fourth quarter of 2026 and an NDA submission in the first half of 2027, provided that LUCIA results are positive. Two phase 3 trials in diabetic macular edema (COMO and CAPRI) are fully enrolled, with topline data expected in the fourth quarter of 2027.

Investigational status and conditionally accepted proprietary name

“has been conditionally accepted by the FDA as the proprietary name for EYP-1901” (opens the source at this quote in a new tab)
“DURAVYU is an investigational product; it has not been approved by the FDA.” (opens the source at this quote in a new tab)

Phase 3 wet AMD program: design and enrollment

“Randomized, double-masked, aflibercept controlled, non-inferiority trials assessing the efficacy and safety of DURAVYU 2.7mg in patients with active wet AMD.” (opens the source at this quote in a new tab)
“The LUGANO trial enrolled 432 patients and the LUCIA trial enrolled 475 patients who were randomly assigned, 1:1, to a DURAVYU 2.7mg arm or an on-label aflibercept control arm.” (opens the source at this quote in a new tab)
“The Phase 3 program was developed with feedback from both the FDA and European Medicines Agency (EMA).” (opens the source at this quote in a new tab)

LUGANO topline result: primary endpoint

“DURAVYU was non-inferior to on-label aflibercept control (nominal p-value = 0.0096) in an ad hoc analysis excluding a 4% asymmetric cohort (9 of 211 patients) who experienced vision loss (≥ 15 letters) unrelated to wet AMD; primary endpoint not achieved in full dataset, confounded by this asymmetric cohort” (opens the source at this quote in a new tab)

“DURAVYU did not achieve statistical non-inferiority in full data set” (opens the source at this quote in a new tab)

LUCIA readout and planned NDA submission

“The Company remains on track to report topline data from the second wet AMD pivotal Phase 3 LUCIA trial in the fourth quarter of 2026.” (opens the source at this quote in a new tab)
“The Company anticipates potentially filing an NDA for DURAVYU for the potential treatment of wet AMD in the first half of 2027.” (opens the source at this quote in a new tab)

Regulatory strategy after LUGANO

“Strategy for NDA Filing in H1 2027, Provided Positive LUCIA Results” (opens the source at this quote in a new tab)
“Pre-NDA meeting in Q4 2026 based on totality of data” (opens the source at this quote in a new tab)
“Multiple precedents for NDA approval in ophthalmology following mixed results across two well-controlled Phase 3 trials” (opens the source at this quote in a new tab)

Planned content of the NDA and supplemental NDA

“If the wet AMD Phase 3 clinical program is successful, we plan on filing a New Drug Application (NDA) with the U.S Food and Drug Administration (FDA) with the initial 56-week efficacy and safety data. A supplemental NDA (sNDA) is planned for the Year 2 safety data only, once complete.” (opens the source at this quote in a new tab)

Diabetic macular edema phase 3 program

“Pivotal Phase 3 COMO and CAPRI clinical trials have completed enrollment, together enrolling over 480 patients in five months.” (opens the source at this quote in a new tab)
“Topline data for both DME trials are anticipated in the fourth quarter of 2027.” (opens the source at this quote in a new tab)

Expedited program designations (Fast Track, Breakthrough Therapy, or Priority Review)

No evidence found.

Regulatory submission: NDA planned for the first half of 2027

“We look forward to a potential New Drug Application (NDA) filing with FDA in the first half of 2027, pending LUCIA results in the fourth quarter of 2026” (opens the source at this quote in a new tab)

Launch