FDA Grants Priority Review to Genentech’s Lucentis Supplemental Biologics License Application for Myopic Choroidal Neovascularization

Source: Genentech

Genentech announced that the FDA has accepted a supplemental Biologics License Application (sBLA) and granted priority review for Lucentis (ranibizumab) for the treatment of myopic choroidal neovascularization (CNV), according to a company news release. The sBLA is based on results from the phase 3 RADIANCE study that demonstrated treatment with Lucentis provided superior visual acuity gains in people with myopic CNV compared to verteporfin photodynamic therapy, the only treatment currently approved by the FDA for myopic CNV.

"With the current FDA-approved therapy, people with myopic choroidal neovascularization achieve only temporary stabilization of vision, while myopic CNV patients treated with Lucentis in the RADIANCE study experienced significant improvement of their vision," Sandra Horning, MD, chief medical officer and head of Global Product Development, said in the news release. "The filing acceptance and priority review for Lucentis brings us one step closer to a potential new option for people with this serious eye condition."

The FDA grants a priority review designation to applications for medicines that treat serious conditions and, if approved, would provide a significant improvement in safety or efficacy. If approved, Lucentis would be the first FDA-approved anti-vascular endothelial growth factor (VEGF) therapy to treat myopic CNV.

In myopic CNV, new, abnormal blood vessels grow directly into the retina. These vessels may break and leak blood or fluid into the retina, possibly causing irreversible central vision loss. Symptoms of mCNV include blurred or distorted vision, a sudden progression of central vision loss and difficulty distinguishing colors.

About the RADIANCE Study

RADIANCE is a phase 3, 12-month, randomized, double-masked, multicenter, active-controlled study comparing the efficacy and safety of Lucentis (0.5 mg) versus verteporfin photodynamic therapy (vPDT) in 277 patients with visual impairment due to myopic choroidal neovascularization (CNV). Patients were randomized into three treatment groups: 106 patients in group 1 received treatment with Lucentis on study day 1, as well as 1 month later, and as needed thereafter; 116 patients in group 2 received treatment with Lucentis on study day 1 and as needed thereafter; 55 patients in group 3 received treatment with vPDT on study day 1 and then received treatment with Lucentis or vPDT after month 3.

After 3 months, the Lucentis groups 1 and 2 gained 10.5 and 10.6 letters in visual acuity, respectively, demonstrating a statistically significant improvement over the vPDT group 3, which gained 2.2 letters. Patients in group 3 were allowed to receive Lucentis after month 3 and were followed until month 12. Treatment with Lucentis and vPDT was generally well-tolerated, with low incidences of ocular (0.7 percent) and non-ocular (4.0 percent) serious adverse events reported in groups 1 and 2, and none in group 3. No deaths or cases of endophthalmitis, retinal detachment, cerebrovascular events or myocardial infarction occurred.

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