Bayer to launch AMD drug in Australia

Berlin-Bayer HealthCare plans to launch aflibercept injection (Eylea, also known as VEGF Trap-Eye) for the treatment of patients with neovascular age-related macular degeneration (AMD) in Australia in the second half of this year after having received approval from the Australian Therapeutic Goods Administration (TGA).

The recommended dose for the recombinant fusion protein will be 2 mg via intravitreal injection per month for 3 consecutive months, followed by 2 mg via intravitreal injection every 2 months.

“[The drug] allows for clinical efficacy that is non-inferior to monthly ranibizumab, but with fewer injections and less frequent office visits. We believe that this may help reduce treatment challenges for [patients with] wet AMD and their physicians in Australia,” said George D. Yancopoulos, MD, PhD, president of Regeneron Research Laboratories, Tarrytown, NY, which is collaborating with Bayer Healthcare on the global development of the drug and maintains exclusive rights to it in the United States.

The TGA approval of aflibercept was based on the results of two phase III clinical studies (VIEW 1 and VIEW 2) that demonstrated that aflibercept dosed every other month, following three initial monthly injections, was non-inferior to ranibizumab injection dosed every 4 weeks. The primary endpoint was maintenance of visual acuity (less than 15 letters of vision loss on an eye chart) over 52 weeks. The most common adverse reactions (each with a frequency of at least 5%) reported in patients receiving aflibercept were conjunctival hemorrhage, cataract, eye pain, vitreous detachment, vitreous floaters, and increased IOP.

The drug is being studied for wet AMD in a phase III clinical trial in China and also is in phase III clinical studies for the treatment of diabetic macular edema, myopic choroidal neovascularization, and branch retinal vein occlusion. Bayer HealthCare has submitted applications for marketing authorization of the drug in Europe, Japan, and other countries. The company owns the exclusive marketing rights for the drug outside the United States, where it will share equally with Regeneron the profits from any future sales.

The drug was approved in the United States for the treatment of wet AMD in November. Regeneron has filed a supplemental biologics license application for aflibercept in the treatment of central retinal vein occlusion in the United States and has been granted a Prescription Drug User Fee Act date of Sept. 23.

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