SOUTH SAN FRANCISCO, Calif. — Following a 6-month priority review, the U.S. Food and Drug Administration has approved ranibizumab for treatment of macular edema due to retinal vein occlusion, Genentech announced in a press release.
"This approval provides an important new medicine for people experiencing the unexpected vision loss associated with macular edema following RVO," Hal Barron, MD, Genentech's executive vice president of global development and chief medical officer, said in the release. "In the Lucentis RVO clinical trials, significantly more people treated with monthly Lucentis showed sustained vision improvement during the 6-month study with an effect seen as early as 7 days."
The approval is based on recently published data from the BRAVO and CRUISE trials.
In the BRAVO trial, patients with branch retinal vein occlusion treated with a 0.3-mg dose of Lucentis (ranibizumab, Genentech) improved a mean 16.6 letters in best corrected visual acuity from baseline, and patients treated with a 0.5-mg dose improved a mean 18.3 letters. Patients who received a sham injection improved a mean 7.3 letters.
The prospective, sham injection-controlled, double-masked, multicenter clinical trial enrolled 397 patients diagnosed with branch retinal vein occlusion who were randomized in a 1:1:1 fashion. The primary outcome measure was change in BCVA at 6 months.
In the prospective, sham injection-controlled, double-masked, multicenter clinical CRUISE trial, which enrolled 392 patients with central retinal vein occlusion randomized in a 1:1:1 fashion to 0.3-mg ranibizumab, 0.5-mg ranibizumab or sham, mean change in BCVA from baseline was 12.7 letters, 14.9 letters and 0.8 letters, respectively.
In both studies, investigators noted that "the safety profile was consistent with previous phase 3 ranibizumab trials, and no new safety events were identified in patients" with branch or central retinal vein occlusion.