Bayer receives approval for Eylea in China

Bayer receives approval for Eylea in China

Bayer receives approval for Eylea in China

The FINANCIAL -- Bayer announced on May 11 that Eylea (aflibercept solution for injection into the eye) has been approved by the Chinese regulatory authorities for the treatment of visual impairment due to neovascular (wet) age-related macular degeneration (wAMD).

This is the second indication for Eylea to be approved in China following its recent decision to approve the drug for treatment of visual impairment due to diabetic macular edema.

“Neovascular age-related macular degeneration is a rapidly progressive eye disease which can lead to permanent vision loss in just a few months if left untreated,” said Dr. Joerg Moeller, Member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Research and Development. “We are delighted that with this approval, patients in China with this devastating disease will soon have access to a therapy that has been demonstrated in clinical trials and real world clinical settings to improve vision and long-term outcomes.”

Worldwide, AMD is estimated to cause blindness in three million people, accounting for 8.7% of all blindness and 50% of blindness in the developed world, with wAMD alone accounting for over 80% of legal blindness in all AMD patients. Without treatment, more than 80% of patients with wAMD would permanently lose some vision within two years and over three-quarters of these patients would be classified as legally blind at three years. The risk of AMD increases with age, and with the number of people over 65 years of age expected to more than double from 390 million to 800 million by 2025, the number of individuals affected by wAMD is also predicted to rise accordingly, according to Bayer.

Data from the SIGHT Phase 3 clinical trial, along with results from VIEW 1 and VIEW 2 studies formed the basis of Bayer’s submission for Eylea in wAMD in China. The SIGHT trial was conducted in China and demonstrated significant vision improvement in patients with wAMD when receiving Eylea. At 28 weeks, patients treated with Eylea gained an average of almost three lines compared to patients in the Photodynamic Therapy group who gained less than one line – measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart).

Eylea is a proven treatment option for patients with visual impairment due to wAMD and consistently delivers excellent outcomes to reduce preventable vision loss, both in randomised clinical studies as well as in real world clinical settings.

Outside of China Eylea has been approved in approximately 100 countries for five indications to treat patients with wAMD and patients with visual impairment due to: macula edema following retinal vein occlusion (RVO; branch RVO or central RVO) and diabetic macular edema (DME). Eylea has also been approved for the treatment of myopic choroidal neovascularization. Around 20 million vials of Eylea have been sold since launch worldwide resulting in an estimated number of almost 3 million patient years of experience.

Bayer and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of Eylea. Regeneron maintains exclusive rights to Eylea in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea, except for Japan where Regeneron receives a percentage of net sales.