FDA issues ‘approvable’ letter for Retaane

FORT WORTH, Texas — An angiostatic cortisene developed for the treatment of wet age-related macular degeneration has received an “approvable” letter from the Food and Drug Administration, the drug’s developer said in a press release.

Retaane 15 mg (anecortave acetate suspension, Alcon) is being assessed in clinical trials for “preserving the vision of patients with wet AMD,” according to the company. Alcon will meet with the FDA to discuss the letter, the clinical studies submitted with the new drug application and other ongoing clinical studies to determine future steps to ensure final approval, the company said in the release.

“We believe that Retaane suspension has a positive impact on the vision of patients with AMD,” said Stella Robertson, PhD, vice president of ophthalmology research and development.

Earlier this year, Retaane was granted fast-track status by the FDA. Two pivotal trial results were used for the NDA. In the first, after 1 year 79% of patients treated with Retaane maintained their vision compared with 53% who received a sham application. In a second study, after 1 year the visual outcomes in patients who received Retaane were not statistically different from those who received photodynamic therapy with Visudyne (verteporfin, Novartis).

Retaane is administered once every 6 months; other injectable drugs are administered as often as nine to 12 times a year, Alcon noted.