Roche : FDA grants priority review to Lucentis (ranibizumab injection) supplemental biologics license application for myopic choroidal neovascularization

Basel, 11 October 2016

FDA grants priority review to Lucentis (ranibizumab injection) supplemental biologics license application for myopic choroidal neovascularization

Roche (SIX: RO, ROG; OTCQX: RHHBY) 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.

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).

About Roche in Ophthalmology

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.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives.

Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare - a strategy that aims to fit the right treatment to each patient in the best way possible.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry seven years in a row by the Dow Jones Sustainability Indices.

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.