FDA Issues Approvable Letter to Alcon for Eye Drug Retaane

Alcon has received an approvable letter from the FDA for Retaane suspension, the firm's top drug candidate targeted at treating wet age-related macular degeneration (AMD).

The Swiss firm said it intends to meet with the FDA to discuss the concerns identified in the letter, and provide the agency with its latest clinical data on Retaane (anecortave acetate), which is being reviewed under the FDA's continuous marketing application program for fast-track-designated products.

Alcon didn't provide details about the FDA's concerns, but said it intends to continue its development efforts for Retaane.

Alcon announced in October 2004 that Retaane failed to meet the primary endpoint of a critical trial comparing the drug to an existing AMD treatment known as photodynamic therapy, but the company elected to pursue FDA approval based on its entire package of clinical data.