An investigation into the increase in a rare side effect in patients receiving Regeneron Pharmaceuticals Inc.'s eye drug Eylea has been linked to syringes used to inject the medicine into the eye.
However, no association between the increase in the rate of the side effect and Eylea itself was found.
Regeneron said in a letter to doctors that increased rates of intraocular inflammation were noted with certain lots of the drug distributed in the U.S. Intraocular inflammation, or uveitis, is inflammation of the uvea — the middle layer of the eye.
The annualized reporting rate of this side effect, which is a known risk factor of eye injections, has ranged from one to four cases per 10,000 injections, the company noted, citing post-marketing surveillance.
Regeneron said Eylea kits that contain syringes linked with higher rates of the inflammation will not be distributed. The New York-based company also asked doctors to not use syringes in the affected kits.
According to Bloomberg News, the syringes are manufactured by Becton Dickinson and Co., which did not immediately return the news wire's call seeking comments.
Bayer AG licenses international marketing rights for Eylea. It said none of the affected syringes were shipped to doctors outside the U.S., Bloomberg News reported, citing a company statement.
The drugmaker has informed the U.S. Food and Drug Administration and the American Society of Retina Specialists of its findings and action plan.
