Trial Shows No Difference in Drugs for Macular Degeneration

Researchers from the Boston University School of Medicine and the Veterans Affairs Boston Healthcare System in Jamaica Plain, Massacusetts have conducted a study that failed to show a difference in efficacy between the existing commercial drugs bevacizumab (Avastin) and ranibizumab (Lucentis) for the treatment of age-related macular degeneration (AMD).

The study, which appears in the on-line issue of the journal Eye, is believed to be the first study to describe one-year outcomes of a prospective, double-masked, randomized clinical trial directly comparing bevacizumab to ranibizuamab. The results suggest patients and the health care system could make sizable financial savings using the less expensive alternative bevacizumab (Avastin).

In this study, patients were enrolled by a two-to-one ratio to receive either the Avastin or Lucentis. Patients were given eye injections of Avastin or Lucentis every month for the first three months, followed by monthly examination and testing. They received further injections on an as needed basis for one year. Fifteen patients received Avastin and seven patients received Lucentis.

The findings show no significant difference in visual acuity and anatomic outcomes between the two groups. Both groups had an average improvement in vision of 1.5 lines on the vision testing chart, and only one patient (who was in the Lucentis group) lost a significant amount of vision, defined as three lines or more. Patients in the Avastin group received an average of eight injections over one year, while patients in the Lucentis group received an average of four injections.

Some 1.75 million people in the U.S. have AMD, a number that is expected to rise to 3 million by 2020. The disease occurs in two forms, exudative (wet) or nonexudative (dry). With wet AMD, loss of central vision can occur quickly. Wet AMD is also known as advanced AMD, and does not have stages like dry AMD.

The standard treatment for wet AMD is ranibizumab (Lucentis, made by  Genentech Inc.), which was FDA approved as an eye injection in 2006. Bevacizumab (Avastin, also made by Genentech Inc.) was FDA approved for the treatment of colorectal cancer in 2004, but has also been used worldwide in an off-label fashion as an eye injection for the treatment of wet AMD. Lucenitis costs approximately $2,000 per injection, while Avastin costs approximately $50 per injection. While both drugs have shown independently to be effective in treating wet AMD, it was uncertain if both drugs were equally effective or if either one was better.

Last October, these same researchers published early, six month outcomes of the same study, which also failed to show a difference in efficacy between these two drugs for treating AMD. The authors call for further studies with larger numbers of participants.