Roche : FDA approves Lucentis (ranibizumab injection) for myopic choroidal neovascularisation

Basel, 06 January 2017

FDA approves Lucentis (ranibizumab injection) for myopic choroidal neovascularisation

• First anti-vascular endothelial growth factor (VEGF) therapy approved to treat patients with myopic choroidal neovascularisation (mCNV) in the US, a condition that can lead to blindness
• Myopic CNV is a complication of severe near-sightedness and most commonly affects people between ages 45 and 64
• Granted Priority Review by the FDA
• Fifth FDA-approved indication for Lucentis since its launch in 2006

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved Lucentis® (ranibizumab injection) 0.5 mg for the treatment of patients with myopic choroidal neovascularisation (mCNV), a complication of severe near-sightedness that can lead to blindness. Lucentis is the first FDA-approved anti-vascular endothelial growth factor (VEGF) therapy to treat mCNV in the US. This is the fifth FDA-approved indication for Lucentis since the medicine was launched in 2006.

This approval is based on the results of the Phase III RADIANCE study, which demonstrated that treatment with Lucentis provided superior visual acuity gains in people with mCNV compared to verteporfin photodynamic therapy (vPDT). At three months, average visual acuity gains for patients treated with Lucentis were more than 12 letters, compared to 1.4 letters for those treated with vPDT.

'Myopic choroidal neovascularisation often strikes adults in the prime of their lives, and can lead to severe vision loss or blindness,' said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. 'With Lucentis, people with this condition now have a new FDA-approved treatment option that has been shown to provide a significant improvement in vision in a clinical study.'

Pathological myopia causes the eye to grow too long from front to back, resulting in near-sightedness. In mCNV, new, abnormal blood vessels grow directly into the retina. These vessels may break and leak blood or fluid into the retina, which can cause irreversible central vision loss. Symptoms of mCNV include spots of central blurred or distorted vision, a sudden worsening of central vision or difficulty distinguishing colours.

Myopic CNV is believed to affect approximately 41,000 people in the US and is a vision-threatening complication of pathological myopia, or severe nearsightedness. People with pathological myopia who are between the age of 45 and 64 are more likely to develop mCNV, and the condition affects more women than men.

About the RADIANCE study

RADIANCE is a Phase III, randomised, double-masked, active-controlled study comparing the efficacy and safety of Lucentis (0.5 mg) versus verteporfin photodynamic therapy (vPDT) in 276 patients with visual impairment due to myopic choroidal neovascularisation (mCNV). Patients were randomized into three treatment groups: two groups of patients randomized to Lucentis received injections guided by pre-specified retreatment criteria and the third group received treatment with vPDT.

At month 3, the Lucentis groups I and II had a mean change in best-corrected visual acuity (BCVA) of +12.1 and +12.5 letters from baseline, respectively, demonstrating a statistically significant improvement over the vPDT group III, which had a mean BCVA change of +1.4 letters from baseline. The efficacy rates between groups I and II were comparable. The efficacy between groups I and II were comparable. Adverse events were similar to those seen in other Lucentis trials.

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 hyper permeability (leakiness) of the vessels.

Lucentis is FDA-approved for the treatment of patients with wet age-related macular degeneration (AMD), macular oedema after retinal vein occlusion (RVO), diabetic macular enema (DME), diabetic retinopathy (DR) in people with DME and myopic choroidal neovascularisation (mCNV). Lucentis safety and efficacy has been studied in more than 9,000 patients, across nine pivotal and 24 clinical trials.

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

Outside the US, Lucentis is approved in more than 110 countries to treat patients with neovascular AMD, for the treatment of DME, and due to macular oedema secondary to both branch retinal vein occlusion (BRVO), central retinal vein occlusion (CRVO) and mCNV.

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 eight 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.