EyePoint's Phase 3 wet AMD trial for its Eylea rival Duravyu missed its primary endpoint, leading to a 70%+ stock plunge and severely undermining its bid to displace Eylea as the leading therapy for wet age‑related macular degeneration.
In the LUGANO trial, Duravyu failed to show non‑inferiority to Eylea on best‑corrected visual acuity at 52–56 weeks, while nine Duravyu patients suffered unexpected, unrelated vision loss that the company says skewed the data.
EyePoint still claims non‑inferiority in an ad hoc analysis excluding those nine patients and points to a 42% reduction in treatment burden (about two fewer injections per year) versus Eylea, but market and analyst reaction has been sharply negative.
A second pivotal trial, LUCIA, is expected to read out in fall 2026, on which EyePoint is now banking to salvage regulatory approval for Duravyu.
Earlier positive Phase 2 data for EYP‑1901 (also based on vorolanib delivered via Durasert) had raised hopes that EyePoint could offer on‑par efficacy to Eylea with half‑yearly dosing, but the Phase 3 stumble has cast serious doubt on that competitive positioning.
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