Regeneron announces publication of one-year results from PULSAR and PHOTON trials

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Regeneron Pharmaceuticals announced the publication of one-year results from the pivotal PULSAR and PHOTON trials for aflibercept 8 mg injection (Eylea HD).

Results were published in The Lancet, specifically detailing data demonstrating Eylea HD extended dosing regimens were non-inferior to aflibercept 2 mg injection (Eylea) 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, MD, FACS, director of research at Retina Consultants of Texas and a trial investigator in a press release from Regeneron. “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.”

The PULSAR and PHOTON trials are 2 double-masked, active-controlled pivotal trials evaluating Eylea HD compared to Eylea. PULSAR is evaluating treatment in wAMD while PHOTON is evaluating treatment in DME. In both trials, patients were randomized into 3 treatment groups to receive either: Eylea HD every 12 weeks, Eylea HD every 16 weeks, or Eylea every 8 weeks.

According to the data published in The Lancet, both PULSAR in wAMD (n=1,009) and PHOTON in DME (n=658) met their primary endpoints. Eylea HD demonstrated non-inferior and clinically equivalent vision gains at 48 weeks with both 12- and 16-week dosing regimens after only 3 initial monthly doses. This is compared to an Eylea 8-week dosing regimen after initial monthly doses of 3 in PULSAR and 5 in PHOTON.¹

Of the wAMD patients, 79% and 77% maintained these extended dosing intervals through 48 weeks as did 91% and 89% of DME patients respectively.¹

The most common adverse reactions reported in ≥3% patients treated with Eylea HD were cataract, conjunctival hemorrhage, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, vision blurred, vitreous floaters, vitreous detachment, corneal epithelium defect, and retinal hemorrhage.¹

Eylea HD was approved by the US Food and Drug Administration (FDA) for the treatment of patients with wAMD, DME and diabetic retinopathy (DR) in August 2023. Eylea 8 mg is approved in the European Union, Japan and other countries, while submissions to other regulatory authorities in additional countries have also been made.

References:

1. EYLEA® HD (AFLIBERCEPT) INJECTION 8 MG PIVOTAL DATA IN WET AGE-RELATED MACULAR DEGENERATION (WAMD) AND DIABETIC MACULAR EDEMA (DME) PUBLISHED IN THE LANCET. Press release; March 8, 2024. Accessed March 8, 2024. https://investor.regeneron.com/news-releases/news-release-details/eylear-hd-aflibercept-injection-8-mg-pivotal-data-wet-age