Alcon discontinues development of anecortave acetate for IOP reduction

Alcon Inc. announced it has discontinued development of anecortave acetate for the reduction of IOP associated with glaucoma.

The company recently reviewed interim efficacy and safety data from more than 200 patients in a large, controlled phase II trial. The findings confirmed previous pilot clinical results that anecortave acetate applied through a single anterior juxtascleral injection measurably reduced IOP for an extended period of time, according to a prepared statement.

Based on detailed analysis of the data, however, and after gaining input from a panel of expert clinical advisers, the company said it determined that the amount of IOP reduction and the response rate provided by even the highest dose were not sufficient to support the novel approach as a viable way to address the problem of patient adherence with eye drop therapy.

The phase II study was designed to evaluate the safety and 3-month IOP-lowering efficacy of a single anterior juxtascleral injection of three doses of anecortave acetate: 24, 48, and 60 mg versus vehicle. The mean reduction of IOP from baseline for the 60-mg dose was 3.8 mmHg, which was statistically significant versus vehicle; however, the mean reduction in IOP was not statistically significant versus vehicle for the other doses, according to the statement.

The goal of the study was to determine whether different doses of anecortave acetate could provide IOP reduction similar to existing topical medications but for a period of 3 months with a single injection.

"The search for alternative delivery routes and new mechanisms of action against glaucoma remains 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."