Long-term safety of anecortave acetate studied in 24-month analysis

November 1, 2005

Alcon Laboratories Inc. reported 24-month data from its comparative study of anecortave acetate suspension (Retaane 15 mg) versus photodynamic therapy (PDT) with verteporfin (Visudyne, Novartis Ophthalmics/QLT Inc.) in the treatment of wet age-related macular degeneration (AMD).

Alcon Laboratories Inc. reported 24-month data from its comparative study of anecortave acetate suspension (Retaane 15 mg) versus photodynamic therapy (PDT) with verteporfin (Visudyne, Novartis Ophthalmics/QLT Inc.) in the treatment of wet age-related macular degeneration (AMD).

The primary aim of the 24-month analysis was to confirm the long-term safety of anecortave acetate suspension, according to Alcon. Safety information from this study showed that no clinically relevant safety issues were observed due to the drug or the posterior juxtascleral depot procedure during the entire course of the study, the company said. Ocular and non-ocular adverse events were reported at similar rates in both arms of the study, reported the company.

In addition to the safety data, Alcon said 2-year data continued to show anecortave acetate suspension is clinically equivalent to PDT with verteporfin. Furthermore, the mean visual acuity for both treatment groups was clinically stable from month 12 to 24.

"We believe these data indicate that Retaane suspension has the potential to play a unique role in the chronic treatment of wet AMD," said Stella Robertson, PhD, Alcon's vice president, ophthalmic development, Fort Worth, TX. "We continue to have discussions with the FDA and other regulatory agencies around the world to gain approval of this drug."