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Retinol inhibitor slows geographic atrophy, development of CNV at 2 years
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CHICAGO — An oral retinol-binding protein inhibitor showed promising results in a phase 2 proof of concept study for geographic atrophy, a clinician reported here.
 Jason Slakter, MD |
Fenretinide (ReVision Therapeutics) slowed the progression of dry geographic atrophy and prevented the development of choroidal neovascularization, Jason Slakter, MD, said at a company-sponsored symposium during the joint meeting of the American Academy of Ophthalmology and Middle East Africa Council of Ophthalmology.
Fenretinide halts the accumulation A2E, a toxic byproduct of retinol (vitamin A), in photoreceptors.The drug is also believed to inhibit the expression of vascular endothelial growth factor proteins that spur neovascularization in the retina, Dr. Slakter said.
"We started with a hypothesis and the data from the study support the hypothesis that reducing retinal binding protein ought to slow progressive atrophy," Dr.Slakter said. "The hypothesis that we started with is supported by the data. That's critical." The drug is also believed to inhibit the expression of vascular endothelial growth factor proteins that spur neovascularization in the retina, Dr. Slakter said.
The 2-year, multicenter randomized study included 246 patients with geographic atrophy. The final study population comprised 153 patients, of which 59 patients received placebo, 47 patients received a daily 100-mg dose of fenretinide and 47 patients received a daily 300-mg dose of the compound.
Study results showed that patients who received either dosage of fenretinide had about half the risk of progressing to wet AMD at 2 years compared with those who received placebo, Dr. Slakter said.
Atrophic lesion size among patients in the 300-mg group was stable between 12 months and 24 months. In addition, retinol-binding protein was reduced more than 60% in 43% of patients in the 300-mg group. Median lesion growth was 30% from baseline in the 300-mg group and 50% from baseline in the placebo group.
Patients with decreased lesion size lost six letters of visual acuity between 12 months and 24 months. Patients in the placebo group lost 11 letters at 24 months, Dr.Slakter said.
A phase 3 trial is scheduled to commence in 2011.
- Disclosure: Dr. Slakter has no direct financial interest in the products discussed in this article, nor is he a paid consultant for any companies mentioned.