Regeneron 'knocks it out of the park' with data for high-dose Eylea: analysts

Apparently, reports of the demise of Regeneron’s Eylea are greatly exaggerated.

That sums up the consensus opinion of analysts, who registered both surprise and awe at the positive data Regeneron posted on Thursday about the higher-dose versions of its macular degeneration mega-blockbuster.

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

“I’ve learned in the past that it’s so hard to bet against Regeneron,” Evercore ISI analyst Josh Schimmer wrote in a note to investors.

For patients given a formulation of Eylea designed to last 16 weeks, 77% of those with wet AMD and 89% of those with diabetic macular edema (DME) were able to maintain their dosing regimens.

The results are timely considering the pressure recently applied by Roche’s January approval of Vabysmo, which requires fewer annual doses (three versus six) of the injected treatment.

Eylea’s data for its high-dose formulation doesn’t just match that of Vabysmo. Analysts from RBC Captial Markets and SVB point out that the results are in fact favorable to those of Vabysmo’s 16-week dose, which saw success in 45-46% of those with wet AMD and 51-53% with wet DME.

Notably, safety issues with the high-dose version remained consistent with the current formulation.

“Overall, we believe the data do likely support approvability and some degree of market conversion to high dose Eylea,” RBC added.

SVB analysts mined another positive from the trial results. They pointed to a secondary endpoint that showed among wet AMD patients, 63% of those who received the high dose were without central subfield fluid after 16 weeks as opposed to 52% of those who were given the current 2-mg dose. Central subfield fluid causes visual impairment.

“Key opinion leaders have previously told us that comparable anatomic improvement results will be important in the perception of high-dose Eylea,” wrote David Risinger of SVB.

Another aspect that will play into high-dose Eylea's uptake, according to Evercore, is whether it will be subject to Medicare negotiation under the Inflation Reduction Act.

“Regeneron should be able to file this as a BLA and in that case, there’s a good chance high-dose Eylea will avoid early negotiation,” Schimmer wrote.

Additionally, SVB points out a factor that could significantly alter the market in the future—the threat of biosimilars.

Last month, when the FDA approved a biosimilar version of Roche’s macular degeneration drug Lucentis—Coherus’ Cimerli—and assigned it interchangeable status without a switching study, it was an indication that Eylea could face the same threat when its patent expires in 2024. SVB points out that there are at least eight Eylea biosimilars that have registered trials.

While Regeneron has patented its high-dose formulation, with an expiration in 2039, it is uncertain whether biosimilars could overcome this protection.