MacuCLEAR to begin Phase 3a Dry AMD trial
After an end of Phase 2 meeting with FDA last week, closely held MacuCLEAR is proceeding with a planned Phase 3a human efficacy study. The company expects to begin dosing the first of 60 patients as soon as final preparations are completed in several of weeks.
“This is a very important milestone for MacuCLEAR,” CEO Phil Ralston said in an email update to stakeholders. “We now have a cleared, viable and rational human clinical efficacy trial that will give us an objective opportunity to prove that [chief scientific officer] Dr. George Chiou’s technology works to prevent the progression of dry AMD,” he added.
MacuCLEAR’s lead proprietary compound MC1101 is being developed to treat the dry form of AMD as an eye drop. The active ingredient of MC1101 has been previously approved by the FDA as an oral antihypertensive drug.