FDA approves Eylea HD for macular edema after retinal vein occlusion
November 21, 2025
1 min learn
Key takeaways:
- The choice is supported by optimistic visible acuity good points discovered within the part 3 QUASAR trial.
- That is the fourth accepted indication for Eylea HD.
The FDA accepted Eylea HD for the therapy of macular edema following retinal vein occlusion, in keeping with a press launch.
Eylea HD (aflibercept 8 mg, Regeneron) is now indicated for treating retinal vein occlusion (RVO) with dosing intervals of as much as each 8 weeks after an preliminary month-to-month dosing interval.
That is the fourth accepted indication for Eylea HD.
This latest approval additionally permits for month-to-month dosing for RVO in addition to the beforehand accepted indications of moist age-related macular degeneration, diabetic macular edema and diabetic retinopathy “for some sufferers who could profit from resuming this dosing schedule,” in keeping with the press launch from Regeneron.
The choice is supported by optimistic information from the part 3 QUASAR trial, by which Eylea HD achieved the research’s main endpoint of visible acuity good points that had been noninferior to these yielded by Eylea (aflibercept 2 mg) at 36 weeks when delivered at a dosing routine of each 4 weeks, as Healio beforehand reported.
The most typical opposed reactions, in 3% or extra of sufferers with RVO, included a rise in IOP, blurred imaginative and prescient, cataract, conjunctival hemorrhage, ocular discomfort and vitreous detachment, in keeping with the discharge.
Authorised dosing intervals for every indication embody each 8 to 16 weeks for sufferers with moist AMD and DME after three preliminary month-to-month doses, each 8 to 12 weeks for sufferers with DR after three preliminary month-to-month doses and each 8 weeks for sufferers with RVO after three to 5 preliminary month-to-month doses.
“We imagine these approvals additional place Eylea HD as a therapy of selection for sure retinal illnesses and underscore our relentless dedication to assembly the wants of sufferers and the retina specialists who deal with them,” George D. Yancopoulos, MD, PhD, co-founder, board co-chair, president and chief scientific officer at Regeneron, mentioned within the launch. “Eylea HD is the primary therapy for retinal vein occlusion that may probably reduce the variety of injections that sufferers obtain in half in comparison with current therapies. And with the addition of a month-to-month dosing choice for all 4 accepted Eylea HD indications, physicians now have higher flexibility and optionality to tailor therapy to fulfill particular person affected person wants.”
Perspective
The FDA accepted Eylea HD for every-4-week dosing throughout all label indications this week primarily based on information from the ELARA neovascular AMD month-to-month dosing trial and QUASAR retinal vein occlusion with macular edema trial.
This can be a large change within the label for Eylea HD. The PULSAR and PHOTON registration trials for Eylea HD had been designed to exhibit the potential sturdiness of aflibercept 8 mg, and so they efficiently achieved that. Nonetheless, in the actual world, many clinicians deal with a dry macula, and neither PULSAR nor PHOTON prioritized dry anatomy within the pursuit of lengthy extension. Though aflibercept is a potent drying agent, there are some sufferers who require dosing extra continuously than each 8 weeks to realize dry anatomy, even with the fourfold increased aflibercept dose in Eylea HD.
Each-4-week dosing unlocks the pliability within the Eylea HD product that can permit prescribers to make use of this agent on their more difficult exudative macular illness sufferers. I’m inspired by the month-to-month dosing information offered from ELARA and QUASAR, and I’m desperate to see how Eylea HD performs with extra frequent dosing in the actual world.
David A. Eichenbaum, MD, FASRS
Director of analysis, Retina Vitreous Associates of FloridaChief medical officer, Community Eye
Disclosures: Eichenbaum studies being a guide, investigator and speaker for Bayer and Regeneron.
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