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EyePoint Inc. stock plunges 70% after Phase 3 LUGANO trial fails to meet primary vision improvement goal

EyePoint Inc. shares fell nearly 70% on Monday after the company's Phase 3 LUGANO trial failed to meet its primary goal of proving the drug duravyu is non-inferior to aflibercept for treating wet age-related macular degeneration. The biotech firm reported that the primary endpoint was missed because nine patients in the duravyu group experienced vision loss for reasons unrelated to the disease, which the company claims skewed the results. Despite the miss, EyePoint Inc. reported positive secondary endpoints, including a 42% reduction in treatment burden and a favorable safety profile. The company plans to file for Food and Drug Administration approval in the first half of next year, pending the results of a second late-stage trial, LUCIA, which is expected in late 2024. Analysts from RBC Capital Markets and Mizuho Securities have noted that while the primary miss is a significant hurdle, the upcoming LUCIA results will be the deciding factor for the drug's future. Investors are now looking toward these results to determine if the drug can successfully compete with current standard-of-care treatments.

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