Eylea HD Approved for Wet AMD, Diabetic Macular Edema, Diabetic Retinopathy

The Food and Drug Administration (FDA) has approved Eylea HD (aflibercept) for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy.

The approval was based on data from the phase 3 PULSAR (N=1009; ClinicalTrials.gov Identifier: NCT04423718) and phase 2/3 PHOTON (N=658; ClinicalTrials.gov Identifier: NCT04429503) trials, which compared the efficacy and safety of Eylea HD (aflibercept 8mg) to Eylea (aflibercept 2mg) in patients with wAME and DME, respectively. Study participants were randomly assigned to receive Eylea HD every 12 weeks or every 16 weeks, or Eylea every 8 weeks. The primary endpoint for both trials was the change from baseline to week 48 in best corrected visual acuity. 

Results from both trials showed that treatment with Eylea HD met the primary endpoint demonstrating noninferior and clinically equivalent vision gains at week 48 with both the 12- and 16-week dosing regimens after 3 initial monthly doses vs Eylea every 8 weeks. The majority of patients treated with Eylea HD were able to maintain the 12- and 16-week dosing regimens through week 48.

The efficacy of Eylea HD in diabetic retinopathy was derived from the PHOTON study. Findings showed that Eylea HD every 16 weeks did not meet the noninferiority criteria for the proportion of patients with a ≥2-step improvement on the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale and is not considered clinically equivalent to Eylea administered every 8 weeks.

The most common adverse reactions reported with Eylea HD were cataract, conjunctival hemorrhage, increased intraocular pressure, ocular discomfort/eye pain/eye irritation, vision blurred, vitreous floaters, vitreous detachment, corneal epithelium defect, and retinal hemorrhage.

Eylea HD is supplied as a sterile, aqueous solution for intravitreal injection in a single-dose vial containing 8mg of aflibercept, a vascular endothelial growth factor (VEGF) inhibitor.