Bayer Receives Approval for Eylea for the Treatment of Myopic Choroidal Neovascularization in Japan

Source: Bayer

Monday, September 22, 2014 | International Approval


Bayer HealthCare has received approval from the Ministry of Health, Labor and Welfare (MHLW) in Japan for Eylea (aflibercept solution for injection) for the treatment of myopic choroidal neovascularization (myopic CNV), according to a company news release. In Japan, pathologic myopia and the associated myopic CNV is the second most common cause of blindness.

“Myopic CNV has a poor prognosis and more treatment options are needed to address the urgent medical need for these patients, many of whom are of working age. This additional approval for Eylea is great news for patients in Japan suffering from this potentially sight-threatening eye condition,” Joerg Moeller, MD, member of the Bayer HealthCare Executive Committee and Head of Global Development, said in the news release. “A treatment option that could not only prevent permanent vision loss but could also improve visual acuity would have great benefits for patients with pathologic myopia.”

The approval is based on positive data from the Phase 3 MYRROR study in myopic CNV. The topline results, in which patients receiving Eylea had a mean improvement in best-corrected visual acuity (BCVA) from baseline at week 24 of 12.1 letters, compared to a loss of 2 letters in patients receiving sham injections ( P<0.0001), were announced at the American Academy of Ophthalmology Congress in New Orleans.

Eylea has been approved in almost 80 countries for the treatment of patients with wet age-related macular degeneration (AMD) and around 60 countries for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). The eye drug is also approved for the treatment of diabetic macular edema (DME) in over 30 countries. Over 2 million doses of the eye drug have been administered since launch. For the treatment of macular edema secondary to branch retinal vein occlusion (BRVO), application for marketing authorization have also been submitted in Europe, Japan, and the U.S.

Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of Eylea. Regeneron maintains exclusive rights to Eylea in the United States. Bayer HealthCare 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 royalty on net sales.

About Phase 3 MYRROR Program

MYRROR was a double-masked, sham-controlled trial that randomized 122 patients to receive either Eylea 2 mg or sham. Patients in the active treatment arm received one initial 2 mg dose of Eylea. Patients were evaluated every 4 weeks and were eligible to receive additional intravitreal injections if the myopic CNV persisted or recurred through week 44. Patients on the sham arm received monthly sham injections through week 20. Starting at week 24, they could receive a single injection of Eylea 2 mg and were eligible to receive additional treatment in case of CNV persistence or recurrence through week 44. The primary endpoint of the study was the mean change at week 24 from baseline in best-corrected visual acuity (BCVA) as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart, a standard chart used in research to measure visual acuity.


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