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Dry AMD Stem Cell Clinical Trial

The first patient in a clinical trial for dry age-related macular degeneration has been enrolled and transplanted with purified human neural stem cells. The HucCNS-SC cells protect host photoreceptors and preserve vision. The phase 1/11 trial will evaluate the safety and effectiveness of these cells as a treatment for dry AMD. 16 patients will be evaluated for a total of five years.

 

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VEGF Trap-Eye Delayed By FDA

The FDA delayed its approval of the VEGF Trap-Eye drug Eylea, despite its advisory panel’s recommendations, and extended the target date for completion of its review of the medicine to November 18th. There were questions on the company’s application regarding chemistry, manufacturing, controls and sales.

The drug, Eylea, manufactured by Regeneron Pharmaceuticals, would compete with Roche’s Lucentis. It only has to be injected every eight weeks, half as often as Lucentis.

Priority Review of NEW AMD Drug

The FDA has granted a priority review for VEGF Trap-Eye, a new drug designed to stop the growth of abnormal vessels in the eye. Trap-Eye is a fusion protein that blocks the growth factors leading to neovascularization in macular degeneration. The priority review sets the decision date at August 20, 2011. Bayer and Regeneron are collaborating on the Trap-Eye treatment for wet AMD. Regeneron has exclusive rights to VEGF Trap-Eye in the US, while Bayer intends to market it outside the US.