Opthea Announces Decision to Discontinue Wet AMD Trials

Core Insights - Opthea Limited announced the termination of the COAST and ShORe trials following negative results, which did not meet the primary endpoint of mean change in best corrected visual acuity (BCVA) from baseline to week 52 [1][2][3] Trial Results - The ShORe trial evaluated the efficacy and safety of sozinibercept in combination with ranibizumab versus ranibizumab monotherapy, but did not achieve its primary endpoint [3] - In patients with minimally classic and occult lesions, the mean change in BCVA was 13.3 letters for the combination therapy every four weeks and 12.9 letters every eight weeks, compared to 14.2 letters for ranibizumab monotherapy [4] - In the overall population, the mean change in BCVA was 13.3 letters for the combination therapy every four weeks and 12.6 letters every eight weeks, versus 14.3 letters for ranibizumab monotherapy [4] - Sozinibercept combination therapy was reported to be well tolerated [5] Corporate Developments - Following the trial results, Opthea and its Development Funding Agreement (DFA) investors agreed to discontinue the development of sozinibercept in wet AMD without triggering a termination event under the DFA [7] - The company is engaged in ongoing discussions with DFA investors to explore options for the best outcome for the company and its shareholders [9] - Opthea estimates it will have unaudited cash and cash equivalents of US$100 million at the end of March 2025 [9]