Advicenne's Sibnayal NDA for DRTA Treatment Accepted for FDA Review

The U.S. Food and Drug Administration has accepted Advicenne Therapeutics' New Drug Application (NDA) for sibnayal, a treatment for diabetic retinopathy with macular edema (DRTA), for priority review. The application was submitted on January 15, 2026, and the FDA’s decision is expected by July 15, 2026. Sibnayal, a novel anti-VEGF agent, demonstrated statistically significant improvement in best-corrected visual acuity (BCVA) over placebo in Phase 3 clinical trials involving 480 patients. The drug is administered via intravitreal injection every eight weeks. Advicenne reported that the NDA submission included data from the pivotal SIB-001 trial, which met its primary endpoint at week 52. Shares of Advicenne Therapeutics (NASDAQ: ADVN) rose 12% in pre-market trading following the announcement.