FDA Approves Anecortave Acetate Suspension for Age-Related Macular Degeneration
May 25, 2005 - 11:04:38 AM

Alcon, Inc. (NYSE:ACL) announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for its New Drug Application (NDA) for RETAANE(R) 15 mg (anecortave acetate suspension). RETAANE(R) suspension is an investigational treatment for preserving the vision of patients with wet age-related macular degeneration (AMD).

Alcon said it will meet with the FDA to discuss the approvable letter, the clinical studies submitted with the NDA and other ongoing clinical studies for RETAANE(R) suspension to determine the steps necessary to gain final approval for the wet AMD indication.

"We believe that RETAANE(R) suspension has a positive impact on the vision of patients with AMD. As part of our mission to preserve and restore vision, we are continuing with all of our development efforts for this drug, which we believe will ultimately lead to approval," said Stella Robertson, Ph.D. and vice president, ophthalmology research and development.

About RETAANE(R) Suspension

RETAANE(R) suspension is an investigational treatment for maintaining vision in patients with wet AMD. The drug is an angiostatic cortisene that inhibits the abnormal growth of blood vessels, a process scientifically known as angiogenesis. Angiostatic cortisenes are derived from the steroid class and engineered to remove chemical groups responsible for side effects, such as the development of cataracts and elevated intraocular pressure leading to glaucoma, while preserving potency against angiogenesis.

RETAANE(R) suspension is administered with a blunt-tipped, curved cannula to deliver the drug behind the eye without puncturing the eyeball. This method of delivery avoids the risk of intraocular infection and retinal detachment, the most common side effects associated with injecting therapeutic agents directly into the eye. In addition, RETAANE(R) suspension requires less frequent dosing (once every six months) compared to some other investigational drugs, which are injected into the eye as often as 9 to 12 times a year. No clinically relevant side effects related to the medication or application procedure were reported in the study.

Alcon has conducted extensive clinical research into RETAANE(R) suspension over the last five years. The company has reported clinical study results from two pivotal studies that formed the basis of its clinical package for its NDA. The first study demonstrated that after one year 79 percent of patients treated with RETAANE(R) suspension maintained their vision, compared to 53 percent of those who received a sham application. The second study demonstrated that after one year the visual outcomes in patients who received RETAANE(R) suspension were not statistically different from those of patients who received photodynamic therapy with Visudyne(R).

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