EyePoint shares tumble as Durayvu misses primary goal in wet AMD trial

EyePoint, a Boston biotech, saw its market value drop by nearly $1 billion after its lead candidate Durayvu failed to demonstrate non-inferiority to aflibercept in a pivotal phase 3 trial for wet age-related macular degeneration (AMD).

The LUGANO study enrolled about 400 patients who received monthly intra-ocular injections of either Durayvu or aflibercept, the active component of Regeneron’s Eylea. The primary endpoint was the change in best-corrected visual acuity after roughly one year.

The trial’s full analysis showed Durayvu did not meet the predefined non-inferiority margin, a result the company attributed in part to an asymmetric cohort of nine patients. Consequently, the data were deemed a negative readout.

Despite the setback, analysts note that the drug still has a potential regulatory pathway, but the market may be reluctant to fund further development until additional data address the efficacy concerns.