MacuCLEAR, Inc., a clinical stage specialty pharmaceutical company focused on discovering and developing novel solutions for vascular disorders of the eye, announced today it is beginning Phase III studies for its lead compound, MC-1101, for early-stage (Dry) age-related macular degeneration (AMD), based on positive feedback during the company's end-of-Phase II meeting with the FDA.
MC-1101 is a proprietary, topically administered eye drop drug for treating and stopping the progression of AMD from the early-stage (Dry AMD) to the late-stage (Wet AMD) by increasing ocular blood flow in the choroidal vessels.
The first stage of MacuCLEAR's double-blinded Phase III study will examine 60 patients, using improvements in visual function as the trial's primary endpoint.
"We're encouraged by the data generated for MC-1101 and are confident we'll meet the FDA's requirements set forth during our end-of-Phase II meeting," said MacuCLEAR president and CEO, Philip G. Ralston. "We undoubtedly believe we're at the forefront of providing patients with AMD a means of preventing this terrible disease from advancing to its later stages."