Roche, with an FDA nod for Vabysmo in hand, looks to challenge Regeneron's dominant Eylea

In a little more than three months, Genentech has gained two FDA approvals to treat wet-age related macular degeneration (AMD). The second came on Friday with the FDA’s blessing of Vabysmo (faricimab), and it covers more than just AMD.

The drug also can treat diabetic macular edema (DME), which makes Vabysmo the lone injectable therapy approved simultaneously in the United States for both conditions. Meanwhile, Vabysmo is also the first bispecific antibody for the eye.

The approval, coupled with an October nod for Genentech's surgical implant system Susvimo, sets up a showdown between the company's ophthalmology franchise and Regeneron and Bayer’s dominant Eylea.

A key advantage for Vabysmo could be its more flexible dosing regimen. While Eylea is administered once every one to two months, Vabysmo—after a series of four monthly injections—can be taken once every one to four months depending on the patient's vision outcomes and the anatomy.

With sales of $8.36 billion in 2020—including $4.95 billion reported in the U.S. by Regeneron—Eylea dominates the massive market. There are roughly 1.1 million people in the U.S. with wet AMD and 750,000 with DME, the companies said. The worldwide count for both conditions is estimated to be 40 million, with wet AMD and DME ranking as two of the top causes of vision loss in adults.

RELATED: FDA greenlights Genentech's eye implant for macular degeneration. Will it be a tough sell?

While Genentech and Roche could have an uphill battle convincing patients to undergo the procedure required for Susvimo, there should be less patient resistance to a conventional treatment such as Vabysmo.  

“We now have the opportunity to offer patients a medicine that could improve their vision, potentially lowering treatment burden with fewer injections over time,” Charles Wykoff, director of research at Retina Consultants of Texas and a Vabysmo trial investigator, said in a release.

At $2,190 per dose, Vabysmo will cost more than Eylea, which goes for $1,850 before any rebates or discounts. But for those patients who are able to switch to a less-frequent dosing schedule, the annual cost could be less. 

The dosing edge for Vabysmo might not last long, however: Regeneron is working on a higher-dose version of Eylea, which could be administered every four months.

In development for more than a decade, Vabysmo targets and inhibits two pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).

These are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation, the companies said. Inhibition of both pathways has been shown to provide potentially complementary benefits, stabilizing vessels and reducing vessel leakage and inflammation more than inhibition of the VEGF-A pathway alone, Genentech and Roche said.

Vabysmo will be available in the coming weeks, the companies said. They also are awaiting evaluation of the treatment by the European Medicines Agency.

RELATED: Regeneron shoots for longer Eylea dosing interval in diabetic retinopathy with NIH data

Four phase 3 studies of Vabysmo, published earlier this month in The Lancet, showed that roughly half of the 3,000 participants needed treatments every four months and 75% could go three months or longer between injections.