SOURCE: Frost & Sullivan

Frost & Sullivan

October 03, 2011 10:20 ET

Frost & Sullivan Lauds MacuCLEAR's Development of a Potentially Blockbuster Drug for Dry Age-Related Macular Degeneration

MacuCLEAR Focuses on Improving the Blood Flow in Dry AMD Patients

MOUNTAIN VIEW, CA--(Marketwire - Oct 3, 2011) - Based on its recent analysis of the retinal diseases market, Frost & Sullivan recognizes MacuCLEAR, Inc. with the 2011 North American Frost & Sullivan Award for New Product Innovation for its flagship drug, MC-1101. This drug treats very early stages of dry age-related macular degeneration (AMD) before it can progress to wet AMD and eventually, blindness.

When people age, the blood flow to the eye reduces, resulting in a build-up of waste, particularly in the Bruch's membrane. This thickening of the membrane causes it to rupture. When the body tries to form new vessels to compensate for the reduced blood flow, they too will breakdown and bleed in the retina when the Bruch's membrane ruptures.

MacuCLEAR's MC-1101 has the ability to restore blood flow by causing vasodilation of the choroid vessels, removing the accumulated waste, and delivering anti-inflammatory and anti-oxidative effects. An analysis of the choroidal blood data suggests that MC-1101 may reach the back of the eye at the macular area to improve choroidal blood circulation following topical ocular instillation.

"Unlike the currently available AMD treatments that are injected into the eyeball, MC-1011 is a topical drug," said Frost & Sullivan Industry Manager Jennifer Brice. "MacuCLEAR has evaluated several novel eye drop delivery systems to facilitate the most effective delivery of MC-1101."

MacuCLEAR has had a collaborative business relationship with Mystic Pharmaceuticals, Inc. to combine MC-1011 with its novel VersiDoser™ delivery system. Standard eyedroppers often deliver too large drops into the eye causing product waste and compliance issues, especially with the elderly population. The VersiDoser™ delivery system, however, consists of individually packaged drops which can be precisely sized and accurately delivered with a unique dispenser that makes it a safe, effective, and easier way to deliver ophthalmic medicine versus traditional eyedroppers. The choice of which novel delivery system will primarily depend on MacuCLEAR's strategic marketing partner.

Due to the high unmet need and lack of treatments for dry AMD, MacuCLEAR has been granted Fast Track status by the Food and Drug Administration (FDA). Going through the abbreviated approval pathway will require less data collection, lower cost of production, reduced time for approval and, ultimately, diminished prices for consumers.

MacuCLEAR's team has a combined experience of more than 75 years in the development and commercialization of life science technologies. The dry AMD market has a potential of more than $5 billion, especially with the rise in population of the elderly and a doubling of AMD cases by 2050.

So far, MacuCLEAR is unique in its focus on increasing the blood flow in dry AMD patients. Its competitors are working on uncovering the potential causes of cellular debris and none of them have been able to progress past Phase II for the treatment of dry AMD.

"MacuCLEAR's MC-1101 has already completed Phase Ib, a Proof of Concept human trial," said Brice. "The results of the study demonstrated that MC-1011 is safe with a low incidence of treatment-emergent adverse events that were generally mild in severity."

MacuCLEAR is ready to initiate Phase 3a efficacy trial. Upon successful conclusion of this trial, the company expects to secure a strategic partnership with a big pharma company to complete a 3b study and bring this drug to market.

Each year, Frost & Sullivan presents this award to the company that demonstrates innovation in developing a product. The recipient leverages leading edge technologies to offer value-added features while increasing the ROI for customers. In turn, the innovation enables the company to acquire new customers and increase their market penetration.

Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis and extensive secondary research to identify best practices in the industry.

About MacuCLEAR, Inc.

MacuCLEAR, Inc. is a specialty pharmaceutical company focused on the discovery and development of novel solutions for the treatment of vascular disorders of the eye. MacuCLEAR's lead product is MC-1101 for the treatment of dry AMD. MC-1101 has successfully completed a Phase Ib/Proof of Concept human clinical trial.

About Frost & Sullivan

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