Dive Brief:

• The Food and Drug Administration has approved two new ways to use a higher-dose, longer-acting version of Regeneron Pharmaceuticals’ Eylea, positioning the medicine to better compete in the eye disease market.
• Regeneron said Wednesday that the FDA cleared Eylea HD to treat macular edema following retinal vein occlusion, making it the only drug that can be administered every eight weeks after an initial period of monthly dosing for that use. Additionally, the agency has now greenlit the medicine to be used every four weeks for patients across all indications, giving doctors more flexibility.
• Regeneron is still waiting for clearance to sell Eylea HD in easier-to-use, pre-filled syringes after an application was tied up by manufacturing issues. The big biotechnology company said it’s working with the original producer, Catalent Indiana, to address the FDA’s concerns and is also planning to submit an application for an alternate manufacturing filler of the syringes by January.

Dive Insight:

Every upgrade to Eylea HD’s label helps as Regeneron fights for prescriptions in an eye disease market it once dominated with original Eylea.

Swiss drugmaker Roche has emerged as a particularly fierce competitor since winning approval in 2022 for Vabysmo, which offered a less frequent dosing schedule than Eylea. Regeneron answered that threat the next year by launching Eylea HD. In 2024, Regeneron recorded $6 billion worth of combined revenue from Eylea and its high-dose counterpart.

The approval for retinal vein occlusion may open up as much as 20% of the market for Eylea HD, Evercore ISI analyst Cory Kasimov wrote in a note to clients. At the same time, the official labeling allowing for more frequent dosing solves a “headache” for doctors, who now won’t have to fight for insurance reimbursement if their patients need an alternate schedule.

“This core asset should now be able to more effectively compete against Roche’s Vabysmo,” Kasimov wrote. While he said the pre-filled syringe approval will be more critical for Regeneron, the two new clearances “cannot be understated and are an important part of the puzzle for Eylea HD.”

Eylea HD was previously approved for treating patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy.

Regeneron shares jumped more than 6% Thursday morning, to trade at almost $749 apiece.