M.S. in Technology Commercialization - 03.02.2009 - MacuCLEAR Gains FDA Fast Track Designation

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03.02.2009 - MacuCLEAR Gains FDA Fast Track Designation

03.02.2009

MacuCLEAR has accomplished several milestones within the last few months.

MacuCLEAR has received FDA Fast Track designation. Fast Track designation is intended to facilitate development and expedite review for drugs that treat serious diseases and fill unmet medical needs. The benefits of Fast Track include scheduled meetings to seek FDA input into development plans, the option of submitting a New Drug Application in sections rather than all components simultaneously, and the option of requesting evaluation of studies using surrogate endpoints.

MacuCLEAR has also announced collaboration with Mystic Pharmaceutical to use Mystic’s novel drug delivery device in its upcoming clinical program. This novel delivery system, in conjunction with MacuCLEAR’s plan to demonstrate pharmacologic activity in their upcoming Phase I Safety trial, are both intended to increase interest with potential strategic partners.

Late January, MacuCLEAR was contacted by the Macular Degeneration Foundation, an organization serving the needs of people with low vision. They included an article on MacuCLEAR in their February Newsletter.

Finally, the Texas Emerging Technology Fund has informed MacuCLEAR that the Governor’s office has signed off on the $1.7M they will receive from this unique state sponsored venture fund.

Douglas Baum, COO of MacuCLEAR, has more than 17 years of experience in the pharmaceutical development industry. Mr. Baum has been directly involved with the development of 15 Federal Drug Administration (FDA) approved and marketed drugs. He has been a part of more than 100 drug development programs with approximately 70 pharmaceutical and biotechnology companies. Mr. Baum has authored more than 15 scientific publications on clinical trial results, which have been published in a variety of scientific journals and presented at a multitude of scientific meetings. Mr. Baum graduated from the MSTC Program in 2007.