Although the trial met its primary efficacy endpoint, the results are disappointing in the context of pivotal trials of Lucentis in monthly dosing regimens that have shown the drug to actually improve vision in patients with wet age-related macular degeneration (AMD) – the leading cause of adult blindness.
On average, patients receiving quarterly Lucentis injections returned to their previous levels of visual acuity by month 12, while patients in a group that received sham injections experienced significant vision loss. The one-year data from this study were presented at the Retinal Physician Symposium in the Bahamas.
At month 12, patients treated with 0.3mg quarterly injections of Lucentis lost an average of 1.6 letters in a visual acuity test, patients receiving 0.5mg of the drug lost 0.2 letters on the test, whereas patients receiving placebo lost 16.3 letters.
“The results of the Lucentis pivotal studies have changed the expectations for the treatment of wet AMD,” said Dr Hal Barron, Genentech’s senior vice president of development and chief medical officer. “While the PIER regimen provided a 16-letter benefit compared to sham, the data suggest that treating patients on a quarterly basis may be less effective than monthly or individualized dosing.”