Clinical TrialsThe incorporation of re-dosing in SOL-1 allows the company to reduce the size of SOL-R while ensuring that it remains well powered for success, thus potentially accelerating the path to NDA submission.
Market OpportunityThere is a large market opportunity and unmet need for an extended wAMD treatment, which benefits both Axpaxli and Duravyu.
Regulatory ApprovalFDA has agreed that SOL-1 and SOL-R together could constitute two complementary and adequate trials to support a potential New Drug Application (NDA) for AXPAXLI in wet AMD.