Anecortave acetate effective at 12 months, phase 2 study shows

FORT WORTH, Texas — Anecortave acetate has been shown to be safe and effective in maintaining vision in patients with exudative age-related macular degeneration, according to Jason S. Slakter, MD.

Dr. Slakter, lead investigator of the clinical trials for Alcon, released new 12-month data on the drug during a conference call on Monday.

Results from the phase 2/3 trial showed anecortave acetate was superior to placebo as well, Dr. Slakter said. At baseline, all patients had essentially equal visual acuities of 20/125; about 80% of the patients in the study had predominantly classic lesions.

A statistically significant difference in mean change in vision was seen between the 15-mg anecortave acetate group and the placebo group, with about twice as much vision loss in the placebo group.

At 12 months, 79% of the anecortave acetate patients lost less than 3 lines of vision compared with 53% of the placebo group. Three percent of the 15-mg treatment group experienced severe vision loss of 6 lines or more, compared with 23% of the placebo group, said Dr. Slakter.

Regarding safety of the drug, Dr. Slakter said the drug is a steroid derivative but does not have any conventional steroid activity.

“It is not an anti-inflammatory medication. It does not cause cataract development, nor does it result in [intraocular pressure] elevation as do conventional steroids,” Dr. Slakter said.

Adverse events were mild and transient and equally distributed between the anecortave acetate group and the placebo group. No patients in the study discontinued treatment due to ocular or systemic adverse events.

Transient visual changes were experienced in the treatment groups. However, Dr. Slakter said more than 50% of these visual changes were in the fellow eye as well as the treatment eye.