- Regeneron Pharmaceuticals Inc. on Wednesday said a recent rise in cases of intraocular inflammation among patients receiving its blockbuster eye drug Eylea appear linked with certain batches of the syringe used to deliver the injectable treatment.
- In response, Regeneron will halt distribution of kits containing syringes from the affected lots, although the New York-based biotech did not identify a particular defect. The increase in safety reports related to intraocular inflammation was flagged by a physician group last fall and first reported by Bloomberg last month.
- Intraocular inflammation is a known side effect of Eylea, cropping up annually in between one and four cases per 10,000 injections, Regeneron reported in a letter sent to healthcare providers Feb. 28.
Eylea (aflibercept), a VEGF inhibitor approved to treat wet age-related macular degeneration and several other eye disorders, comes in a single-use vial prepared for injection by syringe. The kits that contain Eylea also include a syringe and needle.
After receiving reports suggesting a potential increase in cases of intraocular inflammation, Regeneron conducted a review of its production process for the drug, as well as of the components sourced externally (syringe and needle).
While Regeneron took care to note in its recent letter that overall adverse event reporting remained within normal ranges, the company did indicate higher rates than expected were observed with eight lots of Eylea distributed in the U.S.
"Out of an abundance of caution, we are ceasing distribution of the impacted Eylea kits and recommending that practitioners already in receipt of the affected kits not use the included syringes," Regeneron said in a statement.
No association between the reported cases and lots of Eylea drug product itself were identified. In clinical trials, about 1% to 2% of patients who received Eylea experienced intraocular inflammation.
The biotech plans to disclose detailed findings from its investigation at an upcoming medical meeting and has already communicated the results of its investigation to the Food and Drug Administration.
Eylea is Regeneron's best-selling product, accounting for over 60% of the company's revenues in 2017.
Regeneron's issues with the Eylea syringes — if correctly characterized by the company — highlight the difficulties drugmakers can run into with product supply chains that draw components from third-party suppliers.
Mylan N.V., for example, was forced to recall batches of its EpiPen product in several countries worldwide after issues were found with some of the auto-injectors produced by Meridian Medical Technologies Inc., a subsidiary of Pfizer, Inc.