Alcon discontinues anecortave acetate

July 8, 2009

Alcon has discontinued development of anecortave acetate for the reduction of intraocular pressure (IOP) associated with glaucoma.

Alcon has discontinued development of anecortave acetate for the reduction of intraocular pressure (IOP) associated with glaucoma. It recently reviewed interim efficacy and safety data from more than 200 patients in a large, controlled Phase II trial. These data confirmed previous pilot clinical results that anecortave acetate applied through a single anterior juxtascleral injection measurably reduced IOP for an extended period of time. However, based on a detailed analysis of the data, and after gaining input from a panel of expert clinical advisers, the company determined that the amount of IOP reduction and the responder rate provided by even the highest dose were not sufficient to support this novel approach as a viable way to address the problem of patient compliance with eye drop therapy.

The Phase II study was rigorously designed to evaluate the safety and three-month IOP-lowering efficacy of a single anterior juxtascleral injection of three doses of anecortave acetate (24mg, 48mg and 60mg) versus vehicle. The mean reduction in IOP from baseline for the 60mg dose was 3.8 mmHg, which was statistically significant versus vehicle. The mean reduction in IOP was not statistically significant versus vehicle for the other doses. The goal of the study was to determine if different doses of anecortave acetate could provide IOP reduction similar to existing topical medications but for a period of three months with a single injection.

"The search for alternative delivery routes and new mechanisms of action against glaucoma remain among Alcon's most important research strategies," said Sabri Markabi, MD, Alcon's senior vice president of research and development and chief medical officer. "While the results show the possibility of alternative, longer term delivery for glaucoma patients, we are disappointed that anecortave acetate did not prove to have sufficient IOP reduction efficacy to be a successful treatment. However, we will continue our efforts to address the issues of efficacy, patient compliance and other unmet medical needs in the treatment of glaucoma in concert with leading independent researchers around the world."