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Regeneron’s application for Eylea in retinopathy of prematurity accepted for FDA priority review

The rare eye disease often impacts infants who are born before 31 weeks of pregnancy


Regeneron’s supplemental Biologics Licence Application (sBLA) for Eylea (aflibercept) injection to treat Retinopathy of Prematurity (ROP) in preterm infants has been accepted by the US Food and Drug Administration (FDA) for priority review.

ROP is a leading cause of childhood blindness worldwide, with 1,100 to 1,500 infants developing disease severe enough to require medical treatment each year in the US. The rare eye disease often impacts infants who are born before 31 weeks of pregnancy have been completed or who weigh less than 3.3lbs at birth.

Mild cases of ROP may get better without treatment, but some cases require treatment, for which the current standard of care is laser photocoagulation (laser), to keep ROP from causing significant visual impairment and, in some cases, blindness.

The application is supported by data from two randomised global phase 3 trials – FIREFLEYE and BUTTERFLEYE – investigating Eylea 0.4mg versus laser in infants with ROP.

In both trials, approximately 80% of Eylea-treated infants achieved an absence of both active ROP and unfavourable structural outcomes at 52 weeks of age, although their primary endpoint of non-inferiority was not met, with laser demonstrating comparable levels of efficacy that were higher than previously observed in similar ROP trials.

Notably, the time required to complete treatment administration per patient was considerably less for Eylea than for laser, the company reported.

In terms of safety, no new Eylea safety signals were observed in either trial, with adverse events (AEs) in both trials consistent with infant prematurity or to the injection procedure, and with the AEs in similar ROP trials.

Eylea is a VEGF inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels in the eye by blocking VEGF-A and placental growth factor, two growth factors involved in the development of new blood vessels.

Regeneron and Bayer are collaborating on the global development of Eylea, with Regeneron maintaining exclusive rights to Eylea in the US. Bayer has licensed the exclusive marketing rights outside the US, where the companies equally share the profits from sales of Eylea.

Article by
Emily Kimber

13th October 2022

From: Research, Regulatory



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