Research / Studies

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.

 

Dr. Balamurali Ambati, a Utah eye doctor, has invented a device to store and deliver medication to AMD patients, replacing the need for monthly injections. The implant, called iVeena, is a clear horseshoe-shaped ring that can be implanted in the area behind the eye’s lens during cataract surgery. It holds six to eight months of medication and can be refilled with new medicine through a needle and small valve, sparing the patient from ever having a direct injection. Although preclinical research is almost finished, it will take about five years for the device to be on the market.

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.

In an experimental study at Schepens Eye Research Institute, red mice were used to convert skin cells into retinal neurons and thus restore visual function. They found a significant increase in electrical activity in the newly reconstructed retinal tissue, signifying that connections were being made between the new photoreceptor cells  and the rest of the retina.   Michael J.