Description MacuCLEAR Inc. is a specialty clinical-stage pharmaceutical company focused on developing and commercializing novel solutions for vascular disorders of the eye. It's first target is Age Related Macular Degeneration, (AMD), the leading cause of blindness for people over 50 years of age, affecting 30 million people worldwide, representing a $5Billion market, for which there is currently no approved treatment for 90% who have this terrible disease. It is at the Phase II human clinical trials stage.
Products / Services The company currently has 4 patents around this technology. MacuCLEAR obtained, through an exclusive worldwide license from Texas A&M University, MC-1101 and numerous other compounds. Additional research continues in this area and MacuCLEAR intends to file additional patents in the near future.
Technology / Differentiation MacuCLEAR's lead proprietary compound, MC1101, is being developed to treat the dry form of AMD. Challenging conventional wisdom, this novel compound is delivered preservative-free by a proprietary eye drop delivery system. Diabetic retinopathy and other retinal diseases will also be investigated with MacuCLEAR's portfolio of drug candidates. While novel in this ophthalmic application, the active ingredient of MC1101 has been previously approved by the FDA as an oral antihypertensive drug. Its safety and toxicity profile is well characterized. MC1101 has been granted 505 (b) 2 status and has formal Fast Track designation by the FDA. MacuCLEAR's Technology Objective is to prevent progression of Dry AMD to Wet AMD by: 1) restoring choroidal blood flow, 2) thus preventing the rupture of the Bruch's Membrane, the integrity of which is known to be the fundamental difference between the dry and wet forms of AMD; 3) treating aging effects of inflammation and oxidative stress. MacuCLEAR's successful completion of its Phase Ib/POC not only proved MC-1101 is safe and well tolerated by all study subjects, it further proved MC-1101 gets to the back of the eye, and when it gets there, significantly improves choroidal blood flow. Since impaired blood flow has been shown to contribute to the progression of dry AMD, the consensus is these study results suggest 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.
Market / Customers Age Related Macular Degeneration (AMD) is the leading cause of legal blindness in the world, with the early stage, or dry form affecting 90% of the millions who suffer from this pandemic problem of our aging population. The market is huge, representing billions of dollars, and as of now, no approved treatment is available.
Revenue / Funding MacuCLEAR will grow through strategic alliances, consistent with the industry trend of large pharmaceutical and biotech companies seeking novel drugs to fill their product pipelines and diminishing intellectual property portfolios. The company intends to out-license its portfolio of novel drug formulations for various ophthalmic diseases and will derive income from licensing fees, milestone payments and royalties. MacuCLEAR completed its Series A Preferred Stock sale, raising $3.8M, including $1.7M from the Texas Emerging Technology Fund. These funds were used to complete its Phase I Human Clinical Trial. MacuCLEAR is seeking $7M which will be used for its Phase II Human Clinical Study. Stock Purchase details are available through the "Contact Us" page.
MOUNTAIN VIEW, Calif. - 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.
