SAN DIEGO, Sept. 1 /PRNewswire/ -- ReVision Therapeutics Inc. today announced that data from a Phase 2b trial show that fenretinide (RT-101) reduced the incidence of choroidal neovascularization (CNV, wet age related macular degeneration) by about 50 percent in patients with geographic atrophy (GA), the most advanced form of dry age related macular degeneration (AMD).
The data, presented Monday by Alexander M. Eaton, M.D., at the Annual Meeting of the American Society of Retinal Specialists, also showed a trend for reduced GA lesion growth rates in patients receiving fenretinide. These data suggest that fenretinide may have an effect on both GA lesion size as well as the conversion to the more sight-threatening wet form of AMD. Fenretinide is the first oral therapeutic to complete a Phase 2 trial in GA patients.
"These results are very exciting as there are currently no drug therapies for geographic atrophy, and there are no treatments for the prevention of CNV," said Dr. Eaton, who was an investigator in the trial. "We are hopeful that the complete analysis will further validate these findings as fenretinide could slow vision loss in the millions of Americans who face blindness because of this disease."
The double-masked, placebo-controlled, multicenter, Phase 2b study evaluated 246 patients with GA. Patients were randomized into three cohorts and received once-daily doses of 100 mg or 300 mg of fenretinide or placebo for 24 months. Retinal lesion size was measured by color fundus photography, fundus autofluorescence and fluorescein angiography. Patients were also evaluated by contrast sensitivity, reading rate, visual acuity, optical coherence tomography, and the incidence of CNV.
Fenretinide was well tolerated with no severe drug-related adverse events and no significant effects on normal vision function.
At the conclusion of the two-year study, 15 of 82 patients (18.3 percent) in the placebo arm progressed to CNV, while 15 o
|SOURCE ReVision Therapeutics Inc.|
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