Phase III study begins for AMD drop

Plano, TX-MacuCLEAR Inc. is beginning phase III studies for its lead compound, MC-1101, for the treatment of early-stage (dry) age-related macular degeneration (AMD).

MC-1101 is a proprietary, topically administered drop designed to stop the progression of AMD from dry to wet stage by increasing ocular blood flow in the choroidal vessels.

The phase III trial is beginning based on positive feedback received during the company’s end-of-phase II meeting with the FDA. The first stage of the 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 Chief Executive Officer 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 III trial, MacuCLEAR will submit results from non-clinical studies to the FDA before filing for a new drug application.

The active ingredient of MC-1101 has been previously approved by the FDA as an oral antihypertensive drug.

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