Novartis has received the Chinese State Food and Drug Administration (SFDA) approval for Lucentis (ranibizumab) to treat wet (neovascular) age-related macular degeneration (AMD).  The company has also launched Galvus (vildagliptin), an oral treatment for patients with type 2 diabetes approved in China as an add-on to metformin, the standard of care .

Wet AMD is a major cause of blindness and severe vision loss in people over 50. In China, there are an estimated 300,000 new wet AMD patients per year, and as many as 75 million people have uncontrolled type 2 diabetes. The number of people with diabetes in China has nearly quadrupled in recent years, making it the country with the largest number of adults with diabetes in the world.

"Today's announcement demonstrates our continued commitment to providing patients in emerging markets access to innovative treatments where there is significant unmet need," said David Epstein, Head of the Pharmaceuticals Division of Novartis. "We are proud to bring Lucentis and Galvus to patients and physicians in China and support the achievement of the Chinese government's public health goals."

Lucentis is the first licensed therapy in its class available to patients in China. The approval of Lucentis in China for the wet AMD indication is based on comprehensive clinical data and experience, including global and local Chinese clinical studies.  Since its launch, Lucentis has become the standard first line therapy in the treatment of wet AMD and, to date, there are more than 1,000,000 patient-treatment years of exposure for Lucentis.

"There is a huge unmet need for wet AMD patients in China and we have been waiting for the Lucentis approval here since it was first launched in the United States in 2006," said Professor Xiaoxin Li, chairman of the China Fundus Society. "We hope access to Lucentis will improve wet AMD patient treatment outcomes and optimize doctors' experiences."

Wet AMD is a disease that affects the macula, which is the part of the eye that allows one to see fine detail and is responsible for the "straight ahead" central vision necessary for identifying faces and undertaking everyday activities like reading, driving and telling the time.

Lucentis is a humanized therapeutic antibody fragment designed to block all biologically active forms of vascular endothelial cell growth factor-A (VEGF-A). Increased levels of VEGF-A are seen in wet AMD and other ocular diseases such as diabetic macular edema (DME) and retinal vein occlusion (RVO). Lucentis has been designed, developed and formulated specifically for use in ocular disease with the aim of stabilizing and improving visual acuity in these patients.

In 2011, Novartis launched the Luminous programme, one of the largest observational studies in ophthalmology, aiming to recruit over 30,000 patients from clinics across Asia, Australia, Europe, North and South America to further broaden the understanding of ocular disease and the use of Lucentis in its approved indications. Luminous is a five-year observational, international, multicenter program that is expected to provide long-term effectiveness and safety data for Lucentis as well as assess the treatment patterns and health-related quality of life issues of patients treated with Lucentis.

Lucentis is licensed for the treatment of wet AMD in more than 100 countries. Outside of China, Lucentis is also approved in more than 50 countries for the treatment of visual impairment due to DME, and visual impairment due to macular edema secondary to RVO, including both branch- and central-RVO.

Lucentis has a well-characterized safety profile and Novartis systematically monitors the safety and tolerability of Lucentis for licensed indications on an ongoing basis. Its safety profile has been well established in a clinical development programme that enrolled more than 10,000 patients across indications. Serious adverse events related to the injection procedure include endophthalmitis, retinal detachment, retinal tear and traumatic cataract. Other serious ocular events observed among Lucentis-treated patients included intraocular inflammation and increased intraocular pressure. Non-eye related serious side effects, although not common, include heart attacks, strokes and death.

Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the United States. Novartis has exclusive rights in the rest of the world. Lucentis is a registered trademark of Genentech Inc.