EyePoint (EYPT) Stifel 2026 Healthcare Conference 2026 summary

DME program and evidence

• COMO and CAPRI, identical Phase III DME trials, are fully enrolled; top-line data are expected in early Q4 2027. DME is described as a $5B global market, including $3B in the U.S.

• DME involves retinal vessel leakage and inflammatory factors as well as VEGF, unlike wet AMD, which was characterized as primarily VEGF-mediated.

• In Phase II VERONA, the 2.7 mg dose matched EYLEA on visual acuity at week 24, with fewer rescues and significantly less OCT fluid; both DURAVYU doses had 50% of eyes with no DME at trial end.

• VERONA’s dose-dependent reduction in fluorescein leakage and preclinical findings were described as consistent with possible JAK1/IL-6 pathway activity; the mechanism remains unconfirmed.

• Management cited safety, fluid control and reduced treatment burden in wet AMD as supportive read-through to DME; it expects a different DME outcome but noted the Phase III result will determine that.

Wet AMD findings and analysis

• LUGANO and LUCIA missed the primary non-inferiority endpoint; management said DURAVYU showed more than two letters of gain in both trials but did not maintain vision sufficiently versus EYLEA.

• More than 50% of eyes supplement-free after loading received no further treatment through week 56; pooled results for those eyes were non-inferior to unsupplemented EYLEA eyes.

• Across both trials, treatment burden was reduced by an average of about two injections versus on-label EYLEA; management said safety was strong across over 440 patients treated for one year with redosing.

• Ongoing analyses are assessing biomarkers, demographics and baseline OCT fluid levels to identify likely responders and non-responders; no definitive subgroup factor has been identified yet.

• Management said wet AMD Phase III results did not establish TKI activity broadly; measured retinal and choroidal drug exposure exceeded estimated IC50 levels, while redosing raised systemic vorolanib levels without apparent added clinical benefit.

Trial plans and regulatory engagement

• DME rescue criteria were changed from 10 to 5 letters of vision loss and retained the 50-micron fluid threshold; first rescue was generally possible from week 20, and management expects the change to affect few patients.

• No formal FDA discussions had taken place on significant changes to COMO or CAPRI; management said rescue criteria were changed and described these as not requiring a major protocol change.

• Management expects to discuss a potential wet AMD trial design with FDA if ongoing work finds a scientifically supported biomarker or responder subgroup; it described the agency as consistent in applying trial requirements.

• Year-two wet AMD follow-up was extended to build safety data on 300 patients to support a potential DME NDA filing.