All eyes on high-dose Eylea as Roche's new Vabysmo makes moderate impact in blockbuster eye disease market

Roche’s Vabysmo is making inroads into the wet AMD eye disease market, but Regeneron’s behemoth Eylea is holding its own, and a new, higher dose version may further entrench Eylea.

That’s according to the latest survey of 110 ophthalmologists from healthcare research consultants at Spherix. While ophthalmologists initially thought most Vabysmo uptake to be at the expense of Eylea alone, it seems just as much of the new brand’s share is taken from Roche’s cancer drug Avastin, which is used off-label in wet AMD, as well other treatment options.

Vabysmo, approved at the start of this year for wet AMD and launched in the first quarter, was heralded as a genuine contender to the near $9 billion a year that Eylea brings. But it seems the drug is fighting a host of other treatments at the same time, rather than only taking a bite out of Eylea, which is marketed outside the U.S. by Bayer.

Surveyed eye doctors still anticipate Vabysmo share to double in the next six months. Spherix noted in the press release about this survey that the brand has “only captured a fraction of what was originally projected thus far in its launch.”

Roche saw second-quarter sales, announced in July, hit 109 million Swiss francs ($112 million), which the pharma said in an accompanying investor presentation “showed an excellent uptake.,” though this gives no clear picture of its overall trajectory, given that it is just one quarter post-launch. 

So where is Vabysmo falling short in ophthalmologists' eyes? Spherix said it’s not about efficacy, as one-half of physicians believe it outperforms Eylea in that arena. Vabysmo also carried with it a favorable dosing schedule, with its longer duration option compared to Eylea.

What Spherix found was that the absence of a permanent J-code—i.e., a billing code, without which reimbursement becomes tricky—is “a key barrier to uptake for Genentech’s brand.”

“Indeed, insurance/reimbursement concerns is the leading roadblock to biologic use in [wet AMD] overall,” the consultants said in the report, which they add implies that the availability of that J-code for Roche—expected next month—could “allow highly favorable projections for Vabysmo to materialize.”

But there may still be more bumps ahead for the Swiss major, according to Spherix. Roche also needs to contend with a potentially new “game-changing” trial from Eylea, as Regeneron has just this week release new data from its higher 8-mg version of its drug.

The current standard for the therapy is 2 mg, but initial phase 2 data out last year for the higher dose showed an early win. The phase 3 data, posted Thursday, September 8, showed further positives, with the drug hitting its primary endpoint with almost 80% of patients with wet AMD able to maintain a 16-week dosing regimen. Regeneron and Bayer added that they were now submitting these new data to regulators "around the world" as they look to gain updated approvals for the drug in this new dosing format. 

And that could boost its use further: Spherix found that 69% of ophthalmologists agreed that the Eylea 8-mg dosing option would be “a real game changer in [wet AMD],” though this report was made before the phase 3 data were reported. 

And analysts at Piper Sandler agree, writing in a note to clients *again, before this latest data drop) that regarding high-dose Eylea, the firm sees “an increasing level of excitement and willingness to prescribe, such that, if successful, it could indeed preserve a significant amount of market share.”

This comes a month after fellow analysts at SVB cast doubt over Eylea’s long-term future and lowered their 2027 estimates of the drug to $3.4 billion in the U.S., down from the previous estimate of $4.6 billion. The SVB team believes Vabysmo is in fact a “growing competitive threat” to Eylea.

We’ll need a few more quarters to see how this market battle shakes out.

It’s also been a dismal start for Roche’s other new eye disease product Susvimo, its surgical implant for wet AMD, which nabbed FDA approval last October.

Despite being approved for nearly a year, Spherix found that the device “is still not gaining traction.” The consultants believe new, noninvasive drugs like Vabysmo, which offer a longer duration of action, “as well as anticipation of higher dosage options for tried-and-true brands like Eylea” are hampering uptake.