Study shows ranibizumab injection improves vision in branch retinal vein occlusion patients

SOUTH SAN FRANCISCO, Calif. — In a phase 3 study, ranibizumab injection improved vision in patients with macular edema due to branch retinal vein occlusion, Genentech announced in a press release.

The BRAVO trial, a multicenter, randomized, double-masked, sham injection-controlled phase 3 study, is designed to assess the safety and efficacy of Lucentis (ranibizumab) in treating macular edema secondary to branch retinal vein occlusion. The study was conducted by administering six monthly injections of the drug and comparing the results to patients receiving monthly sham injections.

According to the release, the two doses of ranibizumab used in the study - 0.3 mg or 0.5 mg showed a statistically significant improvement in best corrected visual acuity at 6 months compared with sham injection. The safety profile of ranibizumab was consistent with previous experience, and no new adverse events were observed.

"[Retinal vein occlusion] is a devastating disease, and there are no FDA-approved medicines shown to improve vision for 6 months," Hal Barron, MD, executive vice president of global development and chief medical officer of Genentech, said in the release. "We are excited that another pivotal study has demonstrated the important role Lucentis can play in improving vision in people with difficult-to-treat eye disease, and look forward to the results of CRUISE, a phase 3 trial in central [retinal vein occlusion], in the third quarter of this year."

Full BRAVO study results will be presented at the Retina Congress in New York later this year, the release said.