EyePoint Pharmaceuticals suffered a major setback after its experimental drug-device combination, Duravyu, failed to meet the primary endpoint in a Phase 3 trial for wet age-related macular degeneration (AMD). The news sent the company’s shares down more than 70%.
Duravyu reduced the treatment burden for patients by 42% compared with standard therapy, but the study did not demonstrate that the drug was non-inferior to Regeneron’s Eylea in preserving vision. EyePoint attributed the unexpected result in part to vision loss among a small group of patients from causes unrelated to wet AMD.
The company plans to rely on results from a second Phase 3 trial to support a potential FDA submission in the first half of 2027. The outcome highlights the significant clinical and regulatory challenges involved in developing new treatments for retinal diseases, even when a therapy offers the potential to reduce treatment frequency and patient burden.
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