Facing Roche threat, Regeneron eyes June approval for high-dose version of Eylea

With Vabysmo, Roche was first to the market with a long-acting treatment for wet age-related macular degeneration (AMD) and diabetic macular edema (DME).

But Regeneron is countering quickly in development of its souped-up version of powerhouse Eylea (aflibercept).

Thursday, Regeneron said the FDA has accepted for priority review its biologics license application for 8-mg aflibercept to treat AMD, DME and diabetic retinopathy. The regulator assigned a decision date of June 27 of this year, following Regeneron's use of a priority-review voucher.

The agency's rubber-stamping of the application comes six months after Regeneron presented data for its high-dose version of Eylea showing that 77% of patients with AMD and 89% of those with DME could maintain a four-month dosing regimen as opposed to its current formulation which lasts for two months.

“HD Eylea knocks it out of the park,” SVB Securities analysts gushed in a note to investors.

Regeneron and its partner Bayer have responded quickly to a challenge from Roche, which gained approval for Vabysmo in January of 2022. The treatment, the first bispecific antibody for the eye, had twice the staying power of Eylea for many patients, following a once-a-month regimen of four introductory doses.

While Vabysmo has a higher price tag—roughly $2,200 per dose versus $2,000 for Eylea—fewer doses over time mean more savings. Fewer doses is also an important factor for patients considering administration by way of a trip to the clinic and a needle to the eyeball.

If Eylea’s high-dose version is approved, it could regain its edge based on favorable trial data. Vabysmo’s corresponding success extending patients to a four-month regimen was 45% to 46% of those with AMD and 51% to 53% of those with DME.

Earlier this month, Roche presented data from a head-to-head trial pitting Vabysmo against Eylea in retinal vein occlusion (RVO), which shows that more patients on Vabysmo had an absence of blood vessel leakage in the retina.

While the result helps build a case for Vabysmo to be approved for RVO, it also could have implications in Roche’s battle with Regeneron in the treatment of wet AMD and DME. A drier retina with less swelling and fluid generally means clearer vision.

While Vabysmo showed strong uptake in 2022, pulling in sales of 591 million Swiss francs ($633 million), Eylea sales reached $6.3 billion in the U.S. alone.

In the fourth quarter, however, Eylea posted disappointing sales of $1.5 billion, which Regeneron CEO Len Schleifer, M.D., Ph.D., called a “short-term blip which should not affect the trajectory of the molecule at all.”