Macula

A study report from the nutrition research center at Tufts University reveals a delay in development of AMD-like lesions as the result of a lower glycemic index (GI) diet.  The mice on the lower GI diet had less accumulations of debris in the retina.

Low GI foods are whole grain bread, fruits and vegetables.  High GI foods are white bread and white potatoes.  The lower GI foods initiate a slower release of glucose that is more easily processed by cells.

This study “suggests that diet alone is enough to accelerate or delay the formation of lesions.”

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.

VEGF Trap-Eye received unanimous recommendation from an FDA drugs advisory committee for approval. The drug, now called EYLEA, is due for final FDA decision on August 20, 2011.

The advantage of this fusion protein (aflibercept) is that it will be administered every two months, after the initial three monthly doses. The present VEGF blocking drugs usually require ongoing monthly injections. A generally favorable safety profile was observed in the two Phase 3 trials of the drug.

 

Research on producing retinal cells from embryonic stem cells, induced pluripotent stem cells, and even the patient’s own skin cells, has been showing promising results at the University of Wisconsin-Madison's Waisman Center. David Gamm MD, and stem cell scientist, grew these cells and produced retinal cells that responded to signals involved in normal retinal function. He cautioned that there is much work left to be done but is encouraged by the potential.

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.