MacuCLEAR, Inc. (“MacuCLEAR”) and Mystic Pharmaceuticals, Inc., (“Mystic”) announced today preliminary successful results of a Phase Ib Clinical Trial for the treatment and prevention of the progression of Age Related Macular Degeneration (AMD). The preliminary results indicated that MacuCLEAR’s MC-1101 drug is safe and well tolerated by study participants, and has a biological effect on blood flow in the back of the retina. Mystic’s VersiDoser™ ophthalmic delivery system was used by trial participants to self-administer MC-1101 to the front of the eye during the trial. The study included Proof Of Concept (“POC”) indicators. A key finding of the study was the successful migration of the drug to the back of the eye.
“We are very pleased with the groundbreaking results of this study,” said Philip G. Ralston, Jr., President and CEO of MacuCLEAR. “We have confirmed the safety of MC-1101 in humans, a primary endpoint for the study.” Ralston added, “We are excited about the implications of the proof of concept part of this study. Using special laser Doppler flow instrumentation, we showed MC-1101 gets to the back of the eye and significantly modulates the blood flow in the choroid, the tiny blood vessels in the back of the macula portion of the retina. This study provides additional scientific evidence supporting our theory that restoring blood flow in the choroid will have a positive affect on preventing the progression of this terrible disease that is the leading cause of blindness for people over the age of 50 in the world.” MacuCLEAR will publish the full results of study later this year.
Mystic Pharmaceuticals’ President and CEO, Timothy Sullivan, stated, “We are pleased to have partnered with MacuCLEAR to develop a drug/delivery system combination that has the potential to provide a simpler, safer and ultimately cost effective solution to the millions of people suffering from this disease.” Ralston added that, “Mystic’s delivery system provided key benefits for both MacuCLEAR and the trial participants. Mystic’s novel unit dose approach to packaging each eyedrop individually enabled us to use a preservative free formulation and the control Mystic’s technology provides for calibrated precision dose delivery and spray plume definitely enhanced absorption of the drug to the back of the eye.” Patients were able to safely and effectively self-administer MC-1101 throughout the trial using the VersiDoser system. “An overwhelming majority of the trial participants expressed a strong positive preference for using the VersiDoser Delivery System over traditional eye drop delivery,” Sullivan concluded. Mystic will publish study results of trial participant preferences for its VersiDoser Delivery System later this year.
Ralston and Sullivan presented a summary of the trial results at the Texas Emerging Technology Fund Investment Symposium on October 8, 2009 at the Renaissance Hotel in Richardson, Texas. MacuCLEAR and Mystic presented the status of the progress of their companies at this symposium featuring companies that have received investments from the State of Texas Emerging Technology Fund.
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