Clinical Trials
MacuCLEAR has received Investigational New Drug (IND) clearance from the FDA. This IND acknowledges that MC-1101 has been granted 505 (b) 2 status. In a separate letter the FDA designated MC-1101 as having formal "Fast Track" status.
MacuCLEAR has successfully completed its Phase I Human Clinical Trial. Its Phase I trial was designed to confirm MC-1101 safety as well as demonstrate pharmacologic evidence of its novel mechanism of action.
MacuCLEAR is collaborating with Mystic Pharmaceutical, Inc. in its human studies. Mystic has a novel ophthalmic drug delivery device, the VERSIDOSERTM that drops a metered, PRESERVATIVE FREE, dose gently to the patient's eye. The device is designed to help proper placement over the eye and to count the number of drops administered. The controlled drop size avoids "flooding" of the eye and the resultant "blinking" response that can wipe away much of a drug delivered from standard dropper bottles.