Phase 3 trial of wet AMD treatment launched in China

TARRYTOWN, N.Y. — Regeneron Pharmaceuticals and Bayer HealthCare announced they have begun a phase 3 clinical trial of aflibercept for the treatment of wet age-related macular degeneration in China, according to a press release.

Eylea (aflibercept), also known as VEGF Trap-Eye, was recently approved by the U.S. Food and Drug Administration.

The SIGHT trial, which will be led by Bayer, will evaluate the safety and efficacy of the injection, the release said. About 300 patients will be included in the randomized, double-masked analysis, which the release said is the largest retinal trial conducted in China.

"Currently, only photodynamic therapy with verteporfin is approved as a treatment for wet AMD in China, and it is only approved for the subpopulation of patients with predominantly classic wet AMD," Kemal Malik, MD, head of Global Development and member of the Bayer HealthCare Executive Committee, said in the release. "After reporting positive data from our large VIEW program in wet AMD, we look forward to potentially bringing this new treatment to patients with wet AMD in China."

The study will take place over the span of 1 year, the release said. Patients will receive either 2 mg of aflibercept every 2 months, after three initial monthly injections, or photodynamic therapy with verteporfin. At 28 weeks, all patients will be evaluated for improvement and maintenance of vision, and then they will receive aflibercept until the study ends at week 52.

More than 500,000 new cases of wet AMD in patients older than 50 years were reported in China in 2010, according to the release.