European Commission approves anti-VEGF for macular edema secondary to RVO

BASEL, Switzerland — Novartis International AG/Novartis has been granted European Commission approval to market ranibizumab for the treatment of vision loss stemming from macular edema secondary to retinal vein occlusion, the company announced in a news release.

Lucentis (ranibizumab, Genentech) is the only anti-VEGF approved for this indication in the European Union, according to the release.

"Lucentis has proven to be an important therapy for people with difficult-to-treat eye conditions, including wet age-related macular degeneration and patients with vision loss due to diabetic macular edema," David Epstein, division head of Novartis Pharmaceuticals, said in the release. "Lucentis is the first anti-VEGF therapy available for patients with both BRVO and CRVO. We are very pleased that another group of patients with debilitating vision loss has access to an effective licensed therapy."

The approval resulted from two pivotal phase 3 studies, BRAVO and CRUISE, that showed early and sustained visual improvement at 6 months with monthly ranibizumab dosing compared with standard care. Visual acuity gains were maintained from months 7 through 12 with as-needed dosing of ranibizumab, the release said.

In the BRAVO study, about 60% of patients treated with monthly ranibizumab gained at least 15 letters of visual acuity at 6 months, compared with 29% of those treated according to standard practice.

In the CRUISE study, about 48% of patients treated with monthly ranibizumab gained at least 15 letters at 6 months, compared with 17% of those treated according to standard practice.

Ranibizumab was developed by Genentech and Novartis. Genentech holds commercial rights to the agent in the United States; Novartis has exclusive rights outside the U.S.