When Roche and Genentech’s eye drug Vabysmo snared approval in January, it knocked out two of its chief rival’s indications in one fell swoop. Now, the bispecific antibody is muscling in on more of Eylea’s turf with data showing it can go toe-to-toe in a vision-threatening condition that affects more than 1 million people in the U.S.
Genentech on Thursday said Vabysmo aced its endpoints in a pair of phase 3 studies—BALATON and COMINO—that pitted the drug against Regeneron and Bayer’s Eylea in patients with macular edema due to branch and central retinal vein occlusion (BRVO and CRVO), respectively. Patients who received injections of Vabysmo every four weeks for up to 24 weeks charted noninferior visual acuity gains versus those who received Eylea each month, Genentech said in a press release.
The drug also helped with rapid drying of retinal fluid from baseline through the 24-week mark, Genentech added.
BALATON is being conducted in 553 patients with BRVO, while COMINO has enrolled 729 subjects with CRVO or hemiretinal vein occlusion.
Vabysmo works by targeting and blocking pathways involving angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), which are thought to contribute to vision loss by destabilizing blood vessels. This can lead to inflammation and the formation of new leaky blood vessels.
Vabysmo was generally well tolerated in both studies with a safety profile on par with prior clinical showings. Roche and Genentech plan to share the results at an upcoming medical meeting and submit them to global regulatory authorities.
Retinal vein occlusion (RVO) is the second-most common cause of vision loss from a retinal vascular disease and effects more than 1 million people in the U.S., by Roche’s estimation. RVO is further broken down in to two primary subcategories: BRVO, which occurs when one of the four smaller “branches” of the central retinal vein becomes blocked, and CRVO, which is less common and occurs when the eye’s central retinal vein is blocked.
Vabysmo’s archrival Eylea, which was first approved in 2011 for wet age-related macular degeneration (wet AMD), bagged its approval for macular degeneration following RVO back in 2014. The green light, which came on the heels of a diabetic macular edema nod earlier that same year, covered both BRVO and CRVO.
When Vabysmo in January passed green lights for both wet AMD and diabetic macular edema, it became the lone injectable therapy approved simultaneously in the U.S. for both conditions.
In the months since launch, Vabysmo has made inroads into the wet AMD market, but that’s not to say the entrenched Eylea isn’t holding its own; it remains the biggest player in the space and takes home $9 billion a year.
It's much earlier days for Vabysmo, but it brought home 109 million Swiss francs ($112 million) in the second quarter, with Roche hailing the drug's “excellent uptake” thus far. Still, a recent Spherix survey of 110 ophthalmologists paints a murkier picture.
While most doctors polled initially thought the majority of Vabysmo uptake would be at Eylea’s expense alone, it has seemed that as much of the new brand’s share is taken from Roche’s own cancer drug Avastin, which is used off-label in wet AMD, as well as other treatment options. And, while the surveyed doctors still anticipated Vabysmo share would double in the coming months, Spherix noted in its press release about the survey that the brand has “only captured a fraction of what was originally projected thus far in its launch.”
Roche is also battling Eylea with its other new ophthalmology offering Susvimo, where it’s having a decidedly rougher go of things. Aside from sluggish uptake, Roche recently triggered a voluntary recall of the eye drug delivery therapy thanks to manufacturing problems with the device.
New patients won’t be able to start on the therapy for the foreseeable future as Roche and Genentech “make some corrections to the manufacturing process,” with the goal to bring the product back to market “within a year or so,” according to Roche Pharmaceuticals CEO Bill Anderson.