| VEGF Trap-Eye Approval Delayed |
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The anticipated FDA approval of Eylea, a new treatment for wet macular degeneration, has been delayed until November.
The drug, which Regeneron tested in clinical trials under the name VEGF Trap-Eye, was given a fast-track approval process. The FDA Advisory Committee recommended approval, which had been expected this month.
All indications are that it will still be approved, possibly mid-November. The FDA has stated that it needs more time to review the massive amount of data that is provided on any new drug approval. Eylea was shown to be non-inferior to Lucentis, when used every 8 weeks. While still an injection in the eye, the prospect of receiving fewer injections is appealing. Practitioners have been experimenting with the injection schedule for Lucentis and Avastin, the other treatments for wet AMD. Most patients no longer receive the 12 injections a year that were standard for Lucentis. Most important is expanding the choices available to doctors and patients. August 2011 |
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