EYLEA HD (aflibercept) Injection 8 mg Pivotal Data in Wet Age-related Macular Degeneration (wAMD) and Diabetic Macular Edema (DME) Published in The Lancet

Published results show EYLEA HD with extended 12- or 16-week dosing regimens demonstrated non-inferior vision gains to standard of care EYLEA (aflibercept) Injection 2 mg with fixed 8-week dosing in patients with wAMD and DME in the first year

EYLEA HD has shown impressive durable visual improvements and rapid and resilient fluid control with a safety profile comparable to EYLEA

Extended dosing intervals with EYLEA HD have the potential to substantially reduce treatment burden for patients

EYLEA HD has been approved in multiple countries including the U.S., EU and Japan

TARRYTOWN, N.Y., March 08, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced The Lancet published one-year results from the pivotal PULSAR and PHOTON trials for EYLEA HD (aflibercept) Injection 8 mg. Specifically, the publications detailed data demonstrating that EYLEA HD extended dosing regimens were non-inferior to EYLEA (aflibercept) Injection 2 mg for both the treatment of wet age-related macular degeneration (wAMD) 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,” said David M. Brown, M.D., FACS, Director of Research at Retina Consultants of Texas and a trial investigator. “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 wAMD (N=1,009) and PHOTON in DME (N=658) met their primary endpoints, with EYLEA HD demonstrating non-inferior 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 wAMD 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.