EyePoint's (EYPT) phase 3 Lugano trial's failure to meet its primary endpoint raises concerns about Duravyu's potential risks in certain patients and whether data from the second pivotal trial Lucia alone could support regulatory approval, RBC Capital Markets said in a note emailed Tuesday.
The Lucia trial is slightly bigger than the Lugano trial, with topline results expected in Q4. If Lucia meets its primary endpoint, EyePoint said it plans to file for US Food and Drug Administration approval in H1 2027.
A single-trial filing could be challenging, as the FDA may require a stricter non-inferiority standard or longer safety follow-up, analysts said.
Overall, Lucia data could provide a path forward, but uncertainty around the clinical and regulatory outlook is likely to remain until the results are available and EyePoint gets clearer guidance from regulators, analysts said.
RBC Capital Markets downgraded EyePoint to sector perform speculative risk from outperform, and cut its price target to $5 from $37.
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