The FDA has been very busy reviewing ophthalmic drugs recently. Here’s an update.

• Eylea. The FDA has approved Eylea (aflibercept, Regeneron Pharmaceuticals) for the treatment of neovascular (“wet”) age-related macular degeneration.

The approval of Eylea—also known as VEGF Trap-Eye—was based upon the results of two Phase III clinical studies. In these studies, 2mg of Eylea was injected monthly for the first three months then dosed every eight weeks; this was shown to be clinically equivalent to Lucentis (ranibizumab injection, Genentech) dosed every four weeks. The adverse event profile was similar to that seen with Lucentis.

An FDA advisory panel had unanimously recommended approval for Eylea in June; but in August, the FDA extended its review of the drug by three months to check additional data.

• Saflutan. The FDA declined to approve tafluprost, a prostaglandin analog. The glaucoma medicine is already on the market outside of the United States under the brand name Saflutan (Merck). The company did not disclose the FDA’s reasons for rejecting the drug.

• Iluvien. The FDA rejected a new drug application for Iluvien (fluocinolone acetonide, Alimera Sciences), a corticosteroid intravitreal insert for diabetic macular edema (DME). The FDA stated that it was unable to grant approval because the risks for adverse reactions shown in the clinical trials were significant and were not offset by the drug’s benefits. Two additional clinical trials will be needed to demonstrate that the product is safe and effective for the proposed indication.