PXE Awareness

Volume 17, Issue 3 November 2011

FDA Approves New AMD Treatment -

Then Withdraws Approval

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The FDA gave its approval on August 19, 2011 for a new medication to treat wet age related macular degeneration (AMD).  The drug, Eylea (VEGF Trap-Eye) is produced by Regeneron Pharmaceuticals.  If approved, it will compete with Avastin and Lucentis, medications developed by Genentech, which became a division of Roche Pharmaceuticals in 2009.  Lucentis is also approved by the FDA for the treatment of wet AMD.  Avastin was not put forward by Genentech for FDA approval for vision problems as it was developed and approved for certain cancers and thus can be used “off-label” for other problems.  While Lucentis research was underway, a physician in Florida offered AMD patients a tiny injection of Avastin off-label.  His patients who were in the process of losing vision, accepted the risk involved, and to the delight of patients and physician alike, Avastin proved itself a miracle waiting to happen.  It stopped the bleeding in the eye and saved vision.  The word spread and Avastin soon was used widely.  An injection of Avastin costs as little as $50, while a Lucentis injection costs $2,000.

Shortly after Eylea’s FDA approval, the agency withdrew approval for a stated three month period for further review.  A new hearing for possible approval will occur on or after November 18, 2011.

The National Eye Institute, a division of the National Institutes of Health, also is conducting a two year, two-round, comparison of Avastin and Lucentis for the treatment of wet AMD.  First round results have been reported and demonstrate that the two drugs are equally safe and effective for treating wet AMD.

So, if/when approved, how will Eylea (VEGF Trap-Eye) fit into the treatment picture for those who experience wet AMD and PXE?  We do not know yet, but we welcome Eylea as well as the comparison study of Avastin and Lucentis.  It was not so very long ago that patients and physicians faced retinal bleeding disorders with despair.  We at NAPE are overjoyed for those whose vision has been saved by new treatments.  We are deeply grateful for the researchers whose knowledge, skill and determination discover the help we desperately need