GMP Companies Inc has received clearance from the U.S. Food & Drug Administration to expand to a Phase 3 clinical trial for its Eyepass 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 Glaucoma Implant in patients with glaucoma who have failed conventional medical and surgical therapy. To date, preliminary results support the safety of the Eyepass 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 Glaucoma Implant," said Michael Salem, 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 Glaucoma Implant from two glaucoma specialists, Reay Brown, Founding Partner of Atlanta Ophthalmology Associates and Mary Lynch, Chief of Ophthalmology and Associate Chief of Surgery at Veteran's Hospital in Atlanta, GA.