Roche : FDA approves Lucentis (ranibizumab injection) prefilled syringe

Basel, 17 October 2016

FDA approves Lucentis (ranibizumab injection) prefilled syringe

• Lucentis prefilled syringe offers a ready-to-use option to deliver treatment with fewer steps
• First anti-VEGF prefilled syringe FDA-approved to treat people with wet age-related macular degeneration and people with macular oedema after retinal vein occlusion

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) approved the Lucentis(ranibizumab injection) 0.5 mg prefilled syringe (PFS) as a new method of administering the medicine. Like the Lucentis 0.5 mg vial, the 0.5 mg PFS is approved to treat people with wet age-related macular degeneration (AMD) and macular oedema after retinal vein occlusion (RVO). The Lucentis PFS is the first syringe prefilled with an anti-VEGF medicine FDA-approved to treat two eye conditions.

'The FDA approval of the Lucentis prefilled syringe marks a new milestone in our ongoing commitment to people affected by vision-threatening eye diseases,' said Sandra Horning, M.D., chief medical officer and head of Global Product Development. 'With the PFS, physicians have an important new option for administering Lucentis to the hundreds of thousands of people in the U.S. diagnosed with either wet AMD or macular oedema after RVO.'

The Lucentis PFS allows physicians to eliminate several steps in the preparation and administration process, including disinfecting the vial, attaching a filter needle, drawing the medicine from the vial using the needle, removing the filter needle from the syringe and replacing with an injection needle. With the Lucentis PFS, physicians attach the injection needle to the syringe and adjust the dose prior to administration.

The Lucentis 0.5 mg PFS is expected to be available in early 2017.

About Wet AMD

Age-related macular degeneration (AMD) is a disease that impacts the part of the eye that provides sharp, central vision and is a leading cause of blindness in people age 60 and over. Wet AMD is an advanced form of the disease that can cause rapid and severe vision loss. Wet AMD is caused by growth of abnormal blood vessels, also known as choroidal neovascularisation (CNV) or ocular angiogenesis, under the macula. These vessels leak fluid and blood and cause scar tissue that destroys the central retina. This process results in a deterioration of sight over a period of months to years.

Lucentis was approved to treat wet AMD in 2006.

About RVO

RVO is the second-most common cause of vision loss due to retinal vascular disease, which can develop over a long period of time or occur suddenly. It occurs when the normal blood flow through a retinal vein becomes blocked, causing swelling (oedema) and haemorrhages in the retina, which may result in vision loss. Sudden blurring or vision loss in all or part of one eye is common with RVO, although loss of vision can develop over a long period of time. RVO typically affects patients who are more than 50 years old, and the incidence increases with age. People with a history of high blood pressure, hypertension, diabetes and atherosclerosis are at an increased risk for developing RVO.

There are two main types of RVO: branch-RVO and central-RVO. Branch-RVO, which is three times more common than central-RVO, occurs when one of the smaller veins emptying into the main vein of the eye becomes blocked. Usually, the blockage occurs at the site where an artery and a vein cross, and affects only a portion of the retina. Central-RVO, the less common form of RVO, occurs when the main vein of the eye (located at the optic nerve) becomes blocked.

Lucentis was approved to treat macular oedema after RVO in 2010.

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 oedema after retinal vein occlusion (RVO), diabetic macular oedema (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. 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 oedema 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 (wet) AMD, diabetic macular oedema, 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.