MacuCLEAR, Inc. announced that it is beginning Phase 3 studies for MC-1101 for early-stage age-related macular degeneration (AMD). This was based on positive feedback during the end of Phase 2 meeting with the FDA.
The first stage of MacuCLEAR’s double-blinded Phase III study will examine 60 patients, using improvements in visual function as the primary endpoint. 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 (NDA).
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 active ingredient of MC-1101 has been previously approved by the FDA as an oral antihypertensive drug.
For more information call (212) 827-0020 or visit www.macuclear.com.