Alert: Regeneron halts distribution of Eylea kits with affected syringes

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MAR 12, 2018

By Keng Jin Lee

Regeneron Pharmaceuticals, Inc.

Retina/Vitreous

A recent spike in cases of intraocular inflammation among patients receiving aflibercept (Eylea) appear linked with specific batches of syringes, according to Regeneron Pharmaceuticals.

The increase in safety reports related to intraocular inflammation was first noted by the American Society of Retina Specialists (ASRS) in October 2017, and first reported by Bloomberg last month.

In a letter to healthcare providers dated February 28, Regeneron said they conducted an extensive review of manufacturing and distribution processes. The review did not find any association with the anti-VEGF drug itself, but an association was seen with certain batches of the syringe that were included in the following lots of final packaged EYLEA kits:

alert-regeneron-halts-distribution-of-eylea-kits-with-affected-syringes.png

While it’s not issuing a formal recall, Regeneron has ceased distributing the affected kits out of an abundance of caution and recommends that practitioners not use the included syringes. Kits from these lots can be exchanged by calling 1-855-395-3248.

The letter also noted that Regeneron had communicated their findings and action plan to the U.S. Food and Drug Administration (FDA) and the American Society of Retina Specialists (ASRS). They plan to report their findings in greater detail at an upcoming scientific meeting.

https://www.aao.org/headline/alert-regeneron-halts-distribution-of-eylea-kits-w

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