Ranibizumab (Lucentis) Approved in EU for Myopia Complication

Disclosures

July 05, 2013

Ranibizumab (Lucentis, Genentech and Novartis) has been approved by the executive branch of the European Union (EU) to treat impaired vision caused by choroidal neovascularization (CNV) secondary to pathologic myopia, Novartis announced today.

As in the United States, ranibizumab is already approved in the EU to treat neovascular (wet) age-related macular degeneration, macular edema, and diabetic macular edema. Jointly developed by Genentech and Novartis, the drug is marketed by the former company in the United States and by the latter in the rest of the world.

CNV is a major cause of blindness. In people with the disorder, new blood vessels originating in the eye's choroid layer penetrate the sub–retinal pigment epithelium or subretinal space. Myopia is the second most common cause of CNV in the United States and Europe.

The European label for ranibizumab, which inhibits vascular endothelial growth factor, calls for a single injection of the drug with as-needed retreatment based on vision and anatomical changes. In a news release, Novartis stated that patients with CNV in a clinical trial called RADIANCE (Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia) achieved rapid gains in visual acuity after only a single injection of ranibizumab, and that more than 70% of them experienced a reduction in CNV leakage and intraretinal edema.

The decision by the EU's European Commission to approve the drug for the new indication followed a recommendation on May 30 from a committee of the European Medicines Agency, the EU's equivalent of the US Food and Drug Administration.

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