FDA wants more Retaane data

Alcon (ACL) received an approvable letter from FDA for an NDA for Retaane anecortave to treat wet age-related macular degeneration (AMD). FDA told the company that approval would require an additional clinical trial; however, the company said it has no immediate plans to conduct a new study in the indication because of the difficulty of recruiting patients in light of currently available drugs.

ACL will continue to support the Phase III AART trial to reduce the risk for the progression of the dry form to the wet form of AMD. The modified steroid is also in a Phase III trial to reduce intraocular pressure resulting from glaucoma. Previously, the company received an approvable letter and pulled an MAA for Retaane to treat subfoveal choroidal neovascularization (CNV) due to AMD (See BioCentury Extra, Friday, March 03, 2006). ...