Regeneron announced on August 18, 2023, that the US Food and Drug Administration (FDA) approved Eylea HD (aflibercept) Injection 8 mg for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR). Approval was based on 48-week results of the pivotal PULSAR and PHOTON trials, in which Eylea HD demonstrated clinically equivalent vision gains to Eylea (aflibercept) 2 mg injection that were maintained with fewer injections. Eylea HD is the first and only treatment approved in wet AMD and DME for immediate dosing at 8-week and up to 16-week intervals following 3 initial monthly doses. The recommended dose for Eylea HD is 8 mg (0.07 mL of 114.3 mg/mL solution) every 4 weeks for the first 3 months across all indications, followed by 8 mg every 8 to 16 weeks in wet AMD and DME and every 8 to 12 weeks for DR.

“The FDA approval of EYLEA HD is an important advancement in retinal care,” said Peter Kaiser, MD, Chaney Family Endowed Chair in Ophthalmology Research at the Cole Eye Institute and Professor of Ophthalmology at Cleveland Clinic Lerner College of Medicine, in a news release. “With Eylea HD, patients with wet age-related macular degeneration or diabetic retinal disease can now receive less frequent injections after their initial monthly doses and still experience the similar visual gains, anatomic improvements, and safety profile of EYLEA.”

The PULSAR and PHOTON trials were double-masked, active-controlled pivotal trials evaluating Eylea HD compared to Eylea (aflibercept) injection 2 mg. Both the PULSAR trial in wAMD (n=1,009) and PHOTON trial in DME (n=658) met their primary endpoint, with Eylea HD demonstrating noninferior and clinically equivalent vision gains at 48 weeks with both 12-week and 16-week dosing regimens after only 3 initial monthly doses, compared to an Eylea 8-week dosing regimen after initial monthly doses (3 in PULSAR and 5 in PHOTON). The vast majority of patients randomized at baseline to Eylea HD 12-week or 16-week dosing regimens (following 3 initial monthly doses) were able to maintain these dosing intervals through 48 weeks.

The most common adverse reactions (≥3%) reported in patients treated with Eylea HD were cataract, conjunctival hemorrhage, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, blurred vision, vitreous floaters, vitreous detachment, corneal epithelium defect, and retinal hemorrhage.