Alcon Inc reviewed data on the Retaane 15 mg (anecortave acetate for depot suspension) phase II/III study and updated information on two new phase III studies of anecortave acetate at the Association for Vision and Research in Ophthalmology (ARVO) annual meeting in Fort Lauderdale, Fla.

In addition, a physician-initiated study of Retaane with triamcinolone was reviewed at the meeting. Retaane is being developed by Alcon, Inc. as a treatment for successfully preserving the vision of patients with all forms of wet age-related macular degeneration (AMD).

Alcon expects to file a New Drug Application with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2004. This filing will incorporate data from a current, multi-center, phase III clinical trial comparing Retaane with photodynamic therapy (PDT) in 530 patients with wet AMD. If approved, the company will begin marketing the product in the first half of 2005.

Presentations at ARVO showed that Retaane was significantly better than placebo for preserving vision, preventing severe vision loss and inhibiting the growth of all lesion types in patients with wet AMD. At two years, 73 per cent of patients treated with Retaane showed stable or improved vision, while only 47 per cent of placebo-treated patients showed a similar vision outcome (p = 0.035). In addition, 94 per cent of patients experienced no severe vision loss after two years treatment with Retaane. At twelve months, 79 per cent of patients treated with Retaane had stable or improved vision, while only 53 per cent of placebo-treated patients showed a similar vision outcome.