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Syringes in certain Eylea kit lots related to intraocular inflammation

Issue: August 25, 2018

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Philip J. Ferrone

VANCOUVER, British Columbia — Four of 29 Eylea kit lots were associated with 62% of cases of sterile intraocular inflammation following injection that were reported to the American Society of Retina Specialists Research and Safety in Therapeutics Committee, according to the results of a retrospective study.

The review included 92 eyes of 88 patients who experienced inflammation after an Eylea (aflibercept, Regeneron) injection and were voluntarily reported to ASRS by 15 practices throughout the United States from Jan. 7, 2017, to Jan. 19, 2018.

“With regard to clustering of cases, there were four lots that counted for 62% of reported cases. However, overall there were 29 Eylea lot numbers that were involved in those reports. Regeneron issued a statement in late February of 2018 where they associated the inflammation with certain batches of syringes in the Eylea kits,” Philip J. Ferrone, MD, said at the ASRS annual meeting.

Ferrone said 68% of cases in the study were from lots with affected syringes. The mechanism of the inflammation remains uncertain and is likely multifactorial.

Most cases presented 2 days after injection, with 95% of patients reporting symptoms of blurry vision, 62% floaters, 42% pain and 19% photophobia. Most patients in the study received steroid treatments or intravitreal antibiotics, and inflammation resolved in 76% of eyes in a mean of 35 days. Of the resolved eyes, 13% lost two or more lines of visual acuity, Ferrone said. – by Robert Linnehan

Reference:

Ferrone PJ. Aflibercept-related sterile intraocular inflammation. Presented at: American Society of Retina Specialists annual meeting; July 20-25, 2018; Vancouver, British Columbia.

Disclosure: Ferrone reports he is an investigator for and receives grants from Allergan and Genentech; is a stockholder for ArcticDx and Regeneron; is a consultant for and receives honoraria from Mckesson; and is on the advisory board of, is a consultant for and a stockholder of Genentech and receives grants and honoraria.