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Phase 2b Data Suggest ReVision's Oral Fenretinide (RT-101) Slows Lesion Growth, Preserves Vision and Reduces Incidence of Neovascularization in Geographic Atrophy Patients
Date:10/18/2010

the role fenretinide may play in treating our patients."

The double-masked, placebo-controlled, multicenter, Phase 2b study evaluated 246 patients with GA. Patients were randomized into three cohorts and received once-daily, oral 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, the incidence of choroidal neovascularization (CNV) and serum RBP levels. This is the largest study to date for an oral therapeutic agent for treatment of GA. Fenretinide was well tolerated with no severe drug-related adverse events and no significant effects on normal visual function.

Analysis of the lesion and RBP data at the conclusion of the two-year study showed that 43 percent of patients in the 300 mg fenretinide arm had a sustained RBP reduction of at least 60 percent throughout the trial. Those patients had a median lesion size growth of only 30 percent from baseline, compared to a median lesion size growth of about 50 percent in the placebo arm. Visual acuity loss in patients who experienced reduced lesion size growth was stabilized from 12 months to 24 months at six letters lost, while patients in the placebo arm showed progressive loss throughout the trial reaching an average loss of 11 letters at 24 months.

At the conclusion of the two-year study, the incidence of CNV in the placebo arm was 22 percent. Meanwhile, CNV incidence in patients receiving either dose of fenretinide was ~13 percent to 14 percent. The comparable therapeutic effect at both low and high doses of fenretinide suggests a mechanism of action that is not dependent upon reduction of serum RBP.

The accumulation of retinol (vitamin A)-derived toxins in the eye is believed to exacerbate lesion growth leading to progression of GA. Inflammation a
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SOURCE ReVision Therapeutics Inc.
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