Ranibizumab approved for ME after RVO

South San Francisco, CA-The FDA has approved ranibizumab injection (Lucentis, Genentech) for the treatment of macular edema (ME) following retinal vein occlusion (RVO) after a 6-month priority review.

“This approval provides an important new medicine for people experiencing the unexpected vision loss associated with ME following RVO,” said Hal Barron, MD, Genentech’s executive vice president of global development and chief medical officer. “In the [ranibizumab] RVO clinical trials, significantly more people treated with monthly [ranibizumab] showed sustained vision improvement during the 6-month study, with an effect seen as early as 7 days.”

The BRAVO study assessed the safety and efficacy profile of ranibizumab in 397 patients with ME following branch RVO. The CRUISE study assessed the safety and efficacy profile of ranibizumab in 392 patients with ME following central RVO.

During the first 6-month period, participants in both trials received monthly injections of either 0.3 or 0.5 mg of ranibizumab (n = 527) or monthly sham injections (n = 262). The primary endpoint of both studies was mean change from baseline in best-corrected visual acuity (BCVA) at 6 months in patients receiving ranibizumab compared with patients receiving sham injections. The studies were not designed to compare the two doses of ranibizumab.

In the BRAVO study, 61% of patients in the 0.5-mg ranibizumab arm experienced BCVA gains of 15 or more letters from baseline at month six, compared with 29% in the sham injection arm. Patients who received this dosage of ranibizumab had a mean gain of 18.3 letters, compared with 7.3 letters in patients receiving sham injections.

In the CRUISE study, 48% of patients in the 0.5-mg ranibizumab arm had BCVA gains of 15 or more letters from baseline at month six, compared with 17% in the sham injection arm. Patients who received this dosage of ranibizumab had a mean gain of 14.9 letters, compared with 0.8 letters for patients receiving sham injections.

Adverse events reported in the BRAVO and CRUISE trials were similar to previous studies, and no new safety events were observed. In the two studies, the most common ocular adverse events that occurred in the ranibizumab arms included conjunctival hemorrhage (48%) and eye pain (17%).