Opthea Outlines OPT-302 Pivotal Study Designs In Chronic Eye Disorder

Following consultations with FDA and European Medical Agency, Opthea NASDAQ: OPT) has finalized trial designs for two Phase 3 clinical trials to assess 2 mg OPT-302, administered 4-weekly or 8-weekly in wet age-related macular degeneration (AMD).
Each trial will enroll around 990 treatment-naive patients and assess the efficacy and safety of intravitreal 2.0 mg OPT-302 in combination with 0.5 mg Roche's Lucentis (ranibizumab) (ShORe trial) or 2.0 mg Regeneron Pharmaceuticals Inc's REGN Eylea (aflibercept) (COAST trial), compared to ranibizumab or aflibercept monotherapy, respectively.
The primary endpoint for both trials is the mean change in Best Corrected Visual Acuity from baseline to week 52 for OPT-302 combination therapy compared to monotherapy.
Each patient will continue to be treated for a further year to evaluate extended safety and tolerability over two years.
The trials will start in the first quarter of 2021, with topline data expected in the second half of 2023.
Price Action: OPT closed 3.5% lower at $10.93 on Tuesday.