Alcon releases new data for glaucoma candidate

March 14, 2008

Alcon has announced positive efficacy and safety results from its second controlled proof of concept clinical study of anecortave acetate administered as an anterior juxtascleral depot in the sub-Tenon's space to reduce intraocular pressure (IOP) in patients with open-angle glaucoma.

Alcon has announced positive efficacy and safety results from its second controlled proof of concept clinical study of anecortave acetate administered as an anterior juxtascleral depot in the sub-Tenon's space to reduce intraocular pressure (IOP) in patients with open-angle glaucoma.

A total of 89 patients were enrolled and randomly assigned to receive either 7.5 mg of anecortave acetate dosed with 0.25 mL of 30 mg/mL suspension, 15 mg of anecortave acetate dosed with 0.5 mL of 30 mg/mL suspension or 0.5 mL of vehicle. One injection of the drug or vehicle was administered to each patient and IOP was assessed at two weeks, six weeks and three months, with month three predefined as the visit for primary efficacy.

The primary conclusion was that both the 7.5 mg and 15 mg doses of anecortave acetate demonstrated statistically significant lower mean IOP than vehicle at three months follow-up. Approximately 55% of patients in the 7.5 mg and the 15 mg arms were deemed successes at three months. This contrasts with the vehicle treatment group, where approximately 50% of patients were treatment failures by week two.

In terms of safety, the most frequently reported adverse events were related to the procedure and included eye pain, foreign body sensation, hyperaemia and blurred vision, which were reported at an incidence of 5 to 15%.

The study will continue with clinical assessments at six-week intervals.

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