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


Results show 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).

(Image Credit: AdobeStock/Davizro Photography)

(Image Credit: AdobeStock/Davizro Photography)

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.

  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
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