A Food and Drug Administration panel voted unanimously Friday to recommend to approve a new Regeneron Pharmaceuticals Inc. eye drug Eylea for the treatment of a condition that can lead to blindness.
The data suggest that “this is an effective treatment and it’s clearly needed,” said FDA panel member Lynn Drake, a physician at Massachusetts General Hospital. She added that anyone who has dealt with patients with this disease knows how devastating it can be.
This prospective, multicenter, double-masked study randomized 159 patients to one of five monthly or quarterly fixed dosing regimens of VEGF Trap-Eye for 12 weeks followed by as-needed dosing for an additional 40 weeks. The significant anatomic and vision improvements achieved during the initial 12-week fixed-dosing phase were maintained with an average of only two additional injections over the 40-week PRN phase; notably, 44 percent of patients required either no retreatment or only one reinjection. The overall safety profile was similar to that previously reported with other intravitreal anti-VEGF agents.
The panel voted 10-0.
VEGF Trap-Eye treatment would only be necessary every other month, according to the panel’s recommendations. The leading treatment, Roche Holding AG’s Lucentis, must be used monthly.
Decreasing treatment intervals would be an important improvement in the patients’ quality of life, Regeneron representatives said, because the drug must be injected directly into the eye by a physician. Fewer treatments could also lessen side effects from these injections.
“Monthly treatment leads to significant burden on patients, their caretakers and the health-care system,” said Jeffrey Heier, professor of ophthalmology at Tufts University and Harvard medical schools, giving the Regeneron presentation.
Bimonthly injections of VEGF Trap-Eye, whose proposed brand name is Eylea, were shown to be as safe and effective as monthly Lucentis injections in studies performed by Regeneron. The drugs are both shown to halt the progression and improve the vision of patients with wet age-related macular degeneration, which causes vision loss and affects 1.5 million Americans.
In documents released Wednesday, the FDA supported the findings of Regeneron’s studies. The panel continued to discuss labeling recommendations Friday.
Sources from WSJ and American Academy of Ophthalmology Express