OREANDA-NEWS. Roche announced today 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 option 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. “Today’s 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 colours.

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

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.

Roche is committed to the development of medicines for a range of eye diseases that cause significant visual impairment and blindness. Our aim is to delay, prevent or treat vision loss and help improve the lives of people living with these devastating eye conditions. In addition to Lucentis (ranibizumab injection), Roche’s ophthalmic research programs are focused on addressing the leading causes of blindness, including geographic atrophy secondary to age-related macular degeneration (AMD), neovascular AMD, diabetic macular edema, other retinal conditions, and glaucoma.