Eyepoint disclosed that its Phase 3 trial of Duravyu (vorolanib intravitreal insert) for wet age-related macular degeneration failed to maintain vision outcomes with a less frequent injection schedule versus standard-of-care aflibercept (Eylea). The disappointing result undercut the program’s plan for regulatory approval and drove a sharp market reaction. The setback changes the near-term outlook for Duravyu’s dosing regimen and forces Eyepoint to reconsider how to compete in the wet AMD maintenance-treatment landscape. Reporting also noted that a second Phase 3 trial is still expected to report later, but investors were rattled by the primary endpoint miss. In parallel, the trial disappointment appeared to lift sentiment around Ocular Therapeutix, whose competing wet AMD therapy is expected to be submitted to the FDA later this year. Together, the developments reinforce how sensitive late-stage outcomes are in retina—particularly when label differentiation depends on reduced injection frequency.
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