Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Eylea is an eye injection that is indicated for the treatment of the following diseases of the retina:
- Neovascular (Wet) Age-Related Macular Degeneration (AMD)
- Macular Edema Following Retinal Vein Occlusion (RVO)
- Diabetic Macular Edema (DME)
- Diabetic Retinopathy (DR) in Patients with DME
Regeneron Pharmaceuticals is responsible for manufacturing Eylea, which was approved by the FDA in 2011.
Increase in Side Effects
Over the past several months, an increased number of patients who receive Eylea injections have experienced sharp declines in vision, pain, and even vision loss. These symptoms were attributed to intraocular inflammation (IOI), which is a known side effect of Eylea and similar drugs.
According to a Bloomberg article from February 21, 2018, the "FDA received 71 reports last year" out of the 2.2 million vials of Eylea that were distributed, which was "almost triple 2014 when [one million vials were distributed and] the next-highest number were made."
While the total number of reported incidents remains low, the American Society of Retina Specialists (ASRS) felt that the situation warranted a letter to its members. They maintained that the benefits of Eylea far outweigh the reported risks, but that doctors should still be aware of the unexplained increased potential for the IOI side effect.
The manufacturer launched an internal investigation to ascertain the cause of this spike in adverse events in late February.
Regeneron released the following information in a February 28, 2018 letter they sent to healthcare providers:
We did not identify any association of IOI rates with the Eylea drug itself, but an association was seen with certain batches of the syringe included in specific lots of final packaged Eylea kits.
While Regeneron was quick to point the finger at the manufacturer of the syringes included in their Eylea kits--Becton, Dickinson & Company--no specific flaw or contamination of the syringes was discussed.
They did however provide eight lot numbers of Eylea kits that contained "affected syringes," and advised doctors not to use the syringes provided in those lots.
Lastly, they stated that they will provide a more detailed report of their findings in an "upcoming scientific meeting."
We will continue to monitor the medical news concerning Eylea and the spike in incidences of IOI, and report on significant developments as we become aware of them.
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