EyePoint wraps up enrollment early in both pivotal Phase 3 DME trials

summarizeSummary

EyePoint completed enrollment in both pivotal Phase 3 DME trials for DURAVYU ahead of schedule, with over 480 patients enrolled in five months. Topline data is expected in 4Q 2027, adding to the upcoming wet AMD Phase 3 readout starting in August 2026.

check_boxKey Events · Product Development and Regulatory · EYPT

• DME Phase 3 Enrollment Complete

  Both COMO and CAPRI pivotal trials fully enrolled over 480 patients in five months, ahead of schedule, demonstrating strong investigator and patient enthusiasm for DURAVYU.

• Topline Data Timeline Set

  Topline 56-week data for both DME trials anticipated in 4Q 2027, with wet AMD Phase 3 data beginning in August 2026 — two major catalysts approaching.

• Regulatory Alignment

  Phase 3 program designed in alignment with both FDA and EMA, using a non-inferiority design vs. on-label aflibercept, supporting a clear regulatory pathway.

• Competitive Positioning

  DURAVYU is the only TKI in Phase 3 for DME with every-six-month dosing; rapid enrollment and positive DSMC reviews strengthen its first-to-market potential in a $multi-billion market.

auto_awesomeAnalysis · EYPT · Industrial Applications And Services

Months ahead of expectations, EyePoint completed enrollment in its two pivotal Phase 3 trials for DURAVYU in diabetic macular edema (DME), bringing in over 480 patients in just five months. The achievement de-risks the DME program timeline and underscores strong investigator and patient demand for a sustained-delivery alternative to frequent anti-VEGF injections. With topline data now guided to 4Q 2027, the company faces two major Phase 3 readouts: wet AMD data beginning in August 2026 and DME data next year. Following three consecutive positive DSMC reviews, the rapid enrollment strengthens the case that DURAVYU could become a first-to-market, every-six-month treatment across the two largest retinal disease markets.