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FDA Clearance to Expand To Phase 3 Clinical Trial for Glaucoma Treatment.





October 9, 2003.

Press Release.
Source: GMP Companies, Inc.




FORT LAUDERDALE, Fla., Oct. 9 /PRNewswire/ -- GMP Companies, Inc. (privately-held), a health care company that acquires, develops and commercializes novel pharmaceutical, diagnostic and medical device technologies, announced today that it has received clearance from the U.S. Food & Drug Administration to expand to a Phase 3 clinical trial for its Eyepass(TM) Glaucoma Implant, an investigational device for the treatment of patients with glaucoma. Enrollment for the trial has begun and will include up to 15 investigational sites within the United States.


GMP Vision Solutions, Inc., a subsidiary of GMP Companies, is conducting the Phase 3 pivotal trial to assess the safety and effectiveness of the Eyepass(TM) Glaucoma Implant in patients with glaucoma who have failed conventional medical and surgical therapy. To date, preliminary results support the safety of the Eyepass(TM) Glaucoma Implant and its ability to lower abnormally high intraocular pressure, which causes the major symptoms and complications of glaucoma including blindness.


"We are encouraged by the preliminary results from early phases of the clinical trials for our Eyepass(TM) Glaucoma Implant," said Michael Salem, M.D., Executive Vice President of Research and Development for GMP Companies, Inc. "We are hopeful that our device may potentially provide a vital therapy for the millions of patients who suffer from the debilitating effects of glaucoma."


GMP Vision Solutions acquired the technology for the Eyepass(TM) Glaucoma Implant from two glaucoma specialists, Reay Brown, M.D., Founding Partner of Atlanta Ophthalmology Associates and Mary Lynch, M.D., Chief of Ophthalmology and Associate Chief of Surgery at Veteran's Hospital in Atlanta, GA.


Approximately 2.2 million Americans have glaucoma (National Eye Institute) and an additional 1.5 to 2 million may be undiagnosed (Glaucoma Research Foundation and National Eye Institute). Glaucoma is the second leading cause of blindness in the U.S., the first leading cause of preventable blindness and the leading cause of blindness among African-Americans. Worldwide, it is estimated that approximately 67 million people are suspected of having glaucoma.


About GMP Companies, Inc.


GMP Companies, Inc. and its subsidiaries acquire, develop and commercialize novel pharmaceutical, diagnostic and medical device technologies. These technologies are typically licensed or acquired from academic medical centers, individual inventors, research institutions and partner companies. Through our two areas of focus, medical technology and biotechnology, we are developing and commercializing various medical products relating to the treatment and care of patients with medical conditions including diabetes, glaucoma, genetic diseases, cardiovascular diseases, cancer and neurologic disorders. To learn more about the Company, visit our website at www.gmpcompanies.com .


Eyepass(TM) Glaucoma Implant is a trademark of GMP Vision Solutions, Inc., a subsidiary of GMP Companies, Inc.



Copyright 2003 PR Newswire. All rights reserved.






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