Regeneron earns mid-stage win for higher dose of Eylea, hoping to refresh its sales pitch

Tuesday, August 24, 2021

Source: Endpoints News

Regeneron has made its name on the blockbuster success of eye drug Eylea, but with the aging drug facing a raft of competitors the drugmaker is looking for ways to keep its sales pitch fresh. And researchers are blazing a fresh trail on that front with new mid-stage data out today.

Forty-three percent of wet age-related macular degeneration patients dosed with an 8 mg dose of Eylea reported no retinal fluid after four weeks compared with 26.4% of patients receiving a 2 mg dose of the drug, according to topline data from a Phase II study unveiled Tuesday.

The study is part of Regeneron’s ongoing clinical program to expand Eylea’s approved dosing into the 8 mg format, where the drugmaker thinks it can drive more durable responses while keeping side effects to a minimum. The drugmaker has two Phase III studies looking at the 8 mg dose in wet AMD, with early results expected in the second half of 2022.


“We are cautiously optimistic that these early data suggest that a higher dose of (Eylea) may potentially benefit patients with wet AMD, and we look forward to Phase 3 data next year, which will be crucial to understand its overall efficacy and safety,” Regeneron CSO George Yancopoulos said in a statement.

On the safety front, the Phase II results should be particularly encouraging for Regeneron. After 16 weeks, 17% of patients receiving the 8 mg dose reported side effects compared with 22.6% on the 2 mg dose. There were two serious ocular side effects reported, one in the 8 mg cohort and the other in the 2 mg cohort. There were no instances of intraocular inflammation (including occlusive retinal vasculitis), anti-platelet trialists’ collaboration (APTC)-defined arterial thromboembolic events or deaths in either patient group, Regeneron said.

An eventual approval for the 8 mg dose will set up Eylea into the near future as a slate of competitors look to challenge its major lead in wet AMD. One of those would-be competitors, Novartis’ Beovu, has run into a slate of challenges looking for an edge.

In June, Novartis scrapped four late-stage studies for that drug after investigators flagged higher rates of intraocular inflammation while reviewing results from the Phase III MERLIN study. Pitted head-to-head against Eylea and dosed every four weeks following a loading phase, Beovu actually hit the primary endpoint of non-inferiority in change in best corrected visual acuity from baseline out to one year. But there were also more cases of retinal vasculitis and retinal vascular occlusion among those given the Novartis drug — in some cases leading to vision loss.

As a result, the Swiss drugmaker decided to shut down not just MERLIN, but two other studies — dubbed RAPTOR and RAVEN — that are testing the four-week regimen in another indication. It’s also advising physicians not to prescribe the drug “at intervals less than two months beyond the first three doses.”

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