MacuCLEAR Successful human clinical trials for treatment of AMD
MacuCLEAR is gearing up for a Phase 3a efficacy trial that is expected to begin Q4, 2011. It has successfully completed its Phase Ib / POC Human Clinical Trial. Its Phase I clinical trial was designed to confirm MC-1101 safety as well as demonstrate pharmacologic evidence of its novel mechanism of action. Not only did MC-1101 prove to be safe and well tolerated by all study subjects, the Proof of Concept (POC) portion of the study, using sophisticated laser doppler technology, demonstrated the drug reached the back of the eye at the macular area, and improved choroidal blood circulation following topical ocular instillation. Since impaired blood flow has been implicated as a contributing factor in the progression of dry AMD, these study results suggest that MC-1101 may be a useful therapeutic agent for the treatment of dry AMD and the potential multifunctional benefits of MC-1101 to subjects with dry AMD should be further explored.
MacuCLEAR is finalizing its next clinical trial design and regulatory strategy for demonstrating efficacy of MC-1101. Its novel MOA and use of endpoints, with state of the art diagnostic tools are aimed at avoiding the failures of other companies' previous attempts at treating dry AMD. Meetings with collaborators and FDA at ARVO 2011 have provided clear direction for this trial.
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 collaborated with Mystic Pharmaceuticals, Inc. which 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 with 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. Use of the Mystic device in combination with MC-1101 in the marketplace, will ultimately be determined by MacuCLEAR's strategic partner.