Anecortave acetate results not significantly different from PDT

October 22, 2004

The C-01-99 phase III clinical trial, which compared a 15-mg dose of anecortave acetate (Alcon Laboratories) with standard administration of verteporfin for the treatment of neovascular age-related macular degeneration (AMD), found that there was no statistical difference between the two treatments.

New Orleans-The C-01-99 phase III clinical trial, which compared a 15-mg dose of anecortave acetate (Alcon Laboratories) with standard administration of verteporfin for the treatment of neovascular age-related macular degeneration (AMD), found that there was no statistical difference between the two treatments. Forty-five percent and 49% of patients, respectively, lost fewer than three lines of vision. However, two important findings about anecortave acetate were: first, that reflux of anecortave acetate upon administration affects the efficacy of the treatment, and second, that the time of the re-administration of anecortave acetate relative to the previous treatment also affects efficacy. Drug reflex was defined as having occurred when anecortave acetate leached out through the small incision in the conjunctiva through which it was administered.

"These are two potentially controllable factors," said Carl Regillo, MD, of Wills Eye Hospital, Philadelphia, during retina subspecialty day at the American Academy of Ophthalmology annual meeting. He reported that in this study in which 263 patients received anecortave acetate every 6 months and 276 patients received photodynamic therapy (PDT) every 3 months, patients achieved better visual acuity when anecortave acetate was administered again within 6 months of the previous treatment. Some degree of reflux of anecortave acetate occurred in about 50% of patients.

"There was a trend for better visual results when there was no drug reflux and when treatment was re-administered within 6 months of the previous treatment, although the number of patients was small. Anecortave acetate demonstrated an excellent safety profile," Dr. Regillo said.