The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ supplemental biologics licence application (sBLA) for Eylea HD (aflibercept) injection 8mg for priority review.
The application aims to extend the therapy’s use for treating macular oedema after retinal vein occlusion (RVO) and to widen the dosing schedule to monthly intervals across approved indications.
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It is based on data from the Eylea HD clinical programme, including the Phase III QUASAR study assessing the injection in RVO.
The active-controlled Phase III trial is assessing Eylea HD’s safety and efficacy in individuals with macular oedema secondary to RVO, along with those with central, branch or hemiretinal vein occlusion.
The primary endpoint of the trial focused on the mean change in best corrected visual acuity (BCVA) from randomisation through week 36, as per the Early Treatment Diabetic Retinopathy Study letter score.
The QUASAR trial demonstrated that Eylea HD, administered every eight weeks after initial monthly doses, achieved non-inferior visual acuity gains against the standard Eylea injection 2mg given every four weeks.
This double-masked trial involved 591 subjects receiving Eylea HD and 301 receiving the Eylea dose. The safety profile of Eylea HD was comparable to that of Eylea and aligned with the established safety data from previous pivotal trials.
Eylea HD, referred to as Eylea 8mg in Japan and the European Union, is under joint development by the company and Bayer.
In the US, Regeneron holds exclusive rights to Eylea and Eylea HD, while outside the US, Bayer has exclusive marketing rights.
Both companies share profits from Eylea and Eylea HD sales equally in markets outside the US.
Vision loss in adults is often attributed to RVO, which is the second widespread vascular disease affecting the retina.
