MacuCLEAR Inc., a clinical stage specialty pharmaceutical company focused on discovering and developing novel solutions for vascular disorders of the eye, announced it is beginning Phase 3 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 2 meeting with the FDA.
MC-1101 is a 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 3 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 2 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.”
In addition to the data from this Phase 3 trial, MacuCLEAR will submit results from non-clinical studies to the FDA before filing for a new drug application (NDA).
To date, MacuCLEAR has completed a successful Phase Ib/proof of concept human clinical trial for MC-1101 which showed that this drug is not only safe and well tolerated by study subjects, but MC-1101 eye drops also migrate to the back of the eye through proven pathways and provide unique and effective treatment for AMD at the source of the problem by increasing blood flow in the back of the retina.
MacuCLEAR’s technology has been developed based on the findings of George Chiou, Ph.D., chief scientific officer of MacuCLEAR, who spearheaded the investigations that led to the development of MC-1101 for ophthalmic use. Dr. Chiou hypothesized that the pathogenesis of AMD begins with a reduction in choroidal blood flow. This vascular insufficiency is now known as the Chiou syndrome.
Date: April 11, 2012
Source: MacuCLEAR Inc.
Filed Under: Drug Discovery
