EU OKs ranibizumab as anti-VEGF therapy for myopic CNV

Basel, Switzerland-The European Commission has granted Novartis Pharmaceuticals a new indication for ranibizumab (Lucentis) to treat patients with choroidal neovascularization (CNV) secondary to pathologic myopia.

The approval makes ranibizumab the first anti-vascular endothelial growth factor (VEGF) therapy licensed for four indications in the European Union.

According to the European label, treatment of myopic CNV starts with a single injection. Further injections are based on an individualized regimen. Re-treatment is based on vision and anatomical changes, and monitoring is required monthly for the first 2 months and then at least quarterly up to 1 year. In the second year, monitoring is at the discretion of the physician.

Radiance, the Novartis-sponsored clinical trial in patients with myopic CNV, showed that ranibizumab provides rapid and superior improvement in visual acuity compared with the current licensed standard of care, photodynamic therapy with verteporfin (Visudyne, Novartis/Valeant). There is an average 14-letter visual acuity gain in the first year with a median of two injections and more than 60% of patients in the Radiance study did not need any further injections after 6 months.

Rapid visual acuity gains were achieved after only a single injection and more than 70% of patients treated with ranibizumab in the Radiance study experienced a reduction in CNV leakage and intraretinal edema, with central retinal thickness being significantly reduced from as early as month 1. Ranibizumab also has a well-established safety profile and its safety profile in the Radiance study was consistent with other studies, as well as in real-world experience, and no new ocular/non-ocular safety risks were identified.

“This fourth indication for our pioneering ophthalmology drug, [ranibizumab], shows how far we have come since it was first launched in 2006,” said Tim Wright, global head of development for Novartis. “We expect that the use of [ranibizumab] will significantly change the treatment of myopic CNV, as it is the first and only licensed treatment that has been proven to restore vision in patients with visual impairment due to myopic CNV.”

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