Olix Pharmaceuticals, Inc. announced on the 2nd that it has submitted an Investigational New Drug (IND) application for its age-related macular degeneration (AMD) treatment program, “OLX301A,” to the U.S. Food and Drug Administration (FDA).
Olix Pharmaceuticals, Inc. recently received approval for this IND in Australia. In the U.S., the company plans to expand its patient recruitment base by adding up to eight additional clinical trial sites and conduct a multinational clinical trial.
This clinical trial will evaluate the efficacy and safety of OLX301A in a total of 64 patients with age-related macular degeneration (AMD) accompanied by geographic atrophy (GA). The company plans to assess treatment efficacy primarily based on markers of damage in the retinal ellipse (EZ).
Olix Pharmaceuticals, Inc. previously completed a Phase 1 clinical trial of OLX301A in the U.S. and confirmed favorable safety and tolerability. Building on these results, the company intends to thoroughly validate the drug’s therapeutic efficacy in this Phase 2a trial, while also continuing discussions with global pharmaceutical companies regarding technology transfer based on the progress of its clinical development.
