Regeneron’s Eylea HD Wins Two New Approvals as it Plays Catch Up with Roche’s Vabysmo

Regeneron has announced two new FDA approvals for Eylea HD (aflibercept 8 mg), one for the treatment of macular edema following retinal vein occlusion (RVO) and the other a flexible monthly dosing option in existing indications.

For RVO, the dosing regimen involves an initial monthly dosing period followed by administration up to every eight weeks. This marks the first treatment for this indication with dosing up to every eight weeks.

The monthly dosing option extends to the existing indications of wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR).

RVO (which includes branch and central vein occlusion) is the second most common retinal vascular disease after diabetic retinopathy. Until now, most anti-VEGF regimens required monthly injections to maintain vision gains.

With Eylea’s HD’s eight-week interval following monthly loading, there is potential to halve injection frequency, a significant patient-centric win in terms of compliance, clinic burden and real-world durability.

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Fewer injections mean fewer visits and equate to a better chance of long-term adherence, which in retina outcomes is critical. Real-world data shows that break-in treatment patterns and injection gaps undermine vision outcome durability.

The approvals strengthen the Regeneron and Bayer partnered drug’s competitive position against Roche, which disrupted the market in 2022 with its long-acting drug Vabysmo (faricimab).

Roche’s treatment can be given as infrequently as once every four months, compared to Regeneron’s original 2 mg Eylea, which is limited to a maximum dosing interval of every two months.

The approval is based on the Phase III Quasar trial in RVO, showing that Eylea HD dosed every eight weeks achieved non-inferior visual acuity gains compared to the standard Eylea (aflibercept 2 mg) dosed every four weeks.

According to the label for Eylea HD, for wAMD and DME, the approved interval after three initial monthly doses is every eight to 16 weeks, and every eight to 12 weeks for DR.

In the press release announcing the approvals, George D. Yancopoulos, MD, PhD, co-founder, board co-chair, president and chief scientific officer, at Regeneron said: “Eylea HD is the first treatment for retinal vein occlusion that can potentially cut the number of injections that patients receive in half compared to existing therapies. And with the addition of a monthly dosing option for all four approved Eylea HD indications, physicians now have greater flexibility and optionality to tailor treatment to meet individual patient needs.”

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Another highly awaited approval still on the horizon for Regeneron is Eylea HD’s prefilled syringe (PFS). Regeneron and Bayer are trailing Roche on this front as well, as Roche secured FDA approval for Vabysmo’s PFS in July 2024.

In October, the FDA rejected Regeneron’s PFS application, citing unresolved issues at Catalent Indiana, the facility of manufacturing partner Novo Nordisk. Regeneron said it is working with Novo to address the deficiencies flagged during a July inspection at the site. The company said it is planning to resubmit its application in January and will include an alternate PFS manufacturer.

Regeneron launched Eylea over a decade ago. The company says the VEGF inhibitor helped transform the treatment paradigm for certain serious chorioretinal vascular diseases. Eylea is now approved to treat vision-threatening conditions across the lifespan, from retinopathy of prematurity (ROP) in infants to DME, DR, macular edema following RVO and wAMD in older adults.