Genentech (RHHBY) Receives FDA Priority Review for Lucentis as mCNV Treatment

October 11, 2016 6:17 AM EDT
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Genentech, a member of the Roche Group (OTC: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Lucentis (ranibizumab injection) for the treatment of myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. The sBLA is based on results from the Phase III RADIANCE study that demonstrated treatment with Lucentis provided superior visual acuity gains in people with mCNV compared to verteporfin photodynamic therapy, the only treatment currently approved by the FDA for mCNV.

“With the current FDA-approved therapy, people with myopic choroidal neovascularization achieve only temporary stabilization of vision, while mCNV patients treated with Lucentis in the RADIANCE study experienced significant improvement of their vision,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “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 mCNV.

In mCNV, 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.1

Myopic CNV is believed to affect approximately 41,000 people in the U.S.2 and is a common vision-threatening complication of pathological myopia, or severe nearsightedness.1 People between the age of 45 and 64 are more likely to develop mCNV,2 and the condition affects more women than men.2 In addition, people with pathological myopia or of East Asian descent are also at an increased risk.1

About the RADIANCE Study

RADIANCE is a Phase III, 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 (mCNV). Patients were randomized into three treatment groups: 106 patients in group I received treatment with Lucentis on study day 1, as well as one month later, and as needed thereafter; 116 patients in group II received treatment with Lucentis on study day 1 and as needed thereafter; 55 patients in group III received treatment with vPDT on study day 1 and then received treatment with Lucentis or vPDT after month 3.

After three months, the Lucentis groups I and II gained 10.5 and 10.6 letters in visual acuity, respectively, demonstrating a statistically significant improvement over the vPDT group III, which gained 2.2 letters. Patients in group III 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 I and II, and none in group III. No deaths or cases of endophthalmitis, retinal detachment, cerebrovascular events or myocardial infarction occurred.

About Lucentis

Lucentis is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels.

Lucentis is FDA-approved for the treatment of patients with wet age-related macular degeneration (AMD), macular edema after retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR) in people with DME. Lucentis safety and efficacy has been studied in more than 9,000 patients, across eight pivotal and 23 clinical trials.

Lucentis was developed by Genentech, a member of the Roche Group. The company retains commercial rights in the U.S. and Novartis has exclusive commercial rights for the rest of the world.

Outside the U.S., Lucentis is approved in more than 100 countries to treat patients with wet AMD, for the treatment of DME, and due to macular edema secondary to both branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO).

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