New Study Shows Eylea HD with Extended 12- or 16-Week Dosing Demonstrated Noninferior Vision Gains to Standard of Care Eylea
Regeneron announced The Lancet published 1-year results from the pivotal PULSAR and PHOTON trials demonstrating that Eylea HD (aflibercept injection 8 mg) extended dosing regimens were non-inferior to Eylea aflibercept injection 2 mg) for both the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME).
“The publication of 48-week results from PULSAR and PHOTON in The Lancet are a recognition of the important advancement Eylea HD has made in retinal care,” David M. Brown, MD, FACS, Director of Research at Retina Consultants of Texas and a trial investigator, said in a Regeneron news release. “Less than a year after its approval, Eylea HD has already made an impact in the treatment of wet age-related macular degeneration and diabetic macular edema. Eylea HD has provided disease control for my tough-to-treat cases of diabetic eye disease and allowed both my diabetic and wet age-related macular degeneration patients to enjoy less frequent dosing with a similar safety profile to Eylea.”
PULSAR and PHOTON are two double-masked, active-controlled pivotal trials evaluating Eylea HD compared to Eylea. As published in The Lancet, both PULSAR in wet AMD (N=1,009) and PHOTON in DME (N=658) met their primary endpoints, with Eylea HD demonstrating noninferior and clinically equivalent vision gains at 48 weeks with both 12- 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). Furthermore, 79% and 77% of wet AMD patients and 91% and 89% of DME patients, who were respectively randomized to 12- and 16-week dosing, maintained these extended dosing intervals through 48 weeks.
The most common adverse reactions (≥3%) reported in patients treated with Eylea HD were cataract, conjunctival hemorrhage, IOP increased, ocular discomfort/eye pain/eye irritation, vision blurred, vitreous floaters, vitreous detachment, corneal epithelium defect, and retinal hemorrhage.
In August 2023, Eylea HD was approved by the FDA for the treatment of patients with wet AMD, DME, and diabetic retinopathy (DR) based on the 1-year data. Two-year data were presented in 2023 for PULSAR at the EURETINA Congress and for PHOTON at the American Society of Retina Specialists annual meeting.
Eylea HD is being jointly developed by Regeneron and Bayer AG. In the US, Regeneron maintains exclusive rights to Eylea and Eylea HD. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equally the profits from sales of Eylea and Eylea HD (known as Eylea 8 mg outside the U.S.). Eylea 8 mg is approved in the European Union, Japan and other countries. Submissions to other regulatory authorities in additional countries have been made.