With Eylea biosimilar competition creeping in and Roche’s Vabsymo jockeying for market share in key indications, Regeneron is racing to carve out a new market for the high-dose version of its blockbuster eye drug.

In a recent study, the company and its partner Bayer compared Eylea HD to the original version of Eylea in patients with macular edema following retinal vein occlusion (RVO), a common cause of vision loss and an indication in which Eylea has been approved since 2014. 

After 36 weeks, patients who received Eylea HD every eight weeks achieved noninferior visual acuity gains compared with those who received the original version of Eylea every four weeks, Regeneron reported Tuesday.

“With these pivotal results in retinal vein occlusion, Eylea HD with extended dosing has again met the high bar of vision gains and safety seen with standard-of-care Eylea,” Chief Scientific Officer George Yancopoulos, M.D., Ph.D., said in a press release.  

Regeneron and partner Bayer plan to submit the data to regulatory agencies around the world, starting with the FDA during the first quarter of 2025. For the companies, a potential nod in RVO would be a welcome addition to Eylea HD’s label, which currently covers wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy.

Since its August 2023 launch, Eylea HD has started making significant contributions to Regeneron's top line. During this year's third quarter, the drug generated $392 million in U.S. sales.

Meanwhile, a new threat has emerged for the original version of Eylea as Amgen recently launched its biosimilar, Pavblu. Eylea HD isn't subject to that biosimilar competition, driving Regeneron’s belief that the company will “be able to complete well,” CEO Len Schleifer, M.D., Ph.D., said on an October conference call.

Besides Amgen's Eylea biosimilar, Roche’s rival drug Vabysmo has become a force, steadily expanding its U.S. market share in eye disease patient pools that Eylea also covers. That drug won a nod in RVO in 2023 after proving noninferiority to Eylea in clinical trials. 

Despite the threats from Amgen and Roche, Eylea HD’s potential approval in RVO—as well as a launch as a prefilled syringe—could prompt “a little bit of an acceleration” for 2025 sales, Schleifer pointed out on the October call. Sales for the Eylea franchise came out to $1.537 billion during the third quarter, a marginal increase from the second quarter’s $1.535 billion.