- The Food and Drug Administration on Friday granted approval to a new Roche treatment for an eye disorder that can cause blindness in older people. Called Vabysmo, the drug is the fourth FDA-approved therapy for "wet" age-related macular degeneration, a list that includes Regeneron's top-selling treatment Eylea.
- Roche aims to win market share with less frequent dosing. When given as a maintenance therapy, people taking Vabysmo can go as long as four months between shots, compared with every eight weeks for Eylea. Eye injections are done in a physician's office and require monitoring afterwards.
- Vabysmo's launch, which Roche said will occur in "coming weeks," is one of several competitive threats to Eylea's market dominance in 2022. Biosimilars of Roche and Novartis' older eye drug Lucentis are expected to arrive sometime this year, and a long-acting implant that secretes Lucentis' active ingredient has also gained approval in the U.S.
Vabysmo, previously called faricimab, is a newer type of biologic drug, a so-called bispecific antibody that binds to two proteins rather than one. In the case of Vabysmo, Roche's drug binds to a protein called VEGF, which is targeted by Eylea and Lucentis, as well as a second one called Ang-2.
In clinical testing, people with macular degeneration who received Vabysmo up to once every four months saw comparable gains in visual acuity to those who received Eylea once every eight weeks. Vabysmo also gained FDA clearance in a separate condition, diabetic macular edema, for which Eylea and Lucentis are also approved. Roche's pivotal trial for Vabysmo in diabetic eye disease also showed eyesight gains that were comparable to Eylea when dosed up to once every four months.
The longer dosing intervals for both Vabysmo and Eylea are achieved only after an initial "loading" phase, during which patients receive a shot once per month.
Eylea has won market share over Lucentis, which was launched several years before Eylea, through its eight-week dosing interval. Novartis had sought to compete by testing Lucentis with less frequent dosing and by developing the implant, but its efforts were hampered by off-label use of the cancer drug Avastin, which acts on the same protein, as an eye treatment.
Novartis, which holds commercial rights to Lucentis outside the U.S., separately developed a VEGF-blocking drug called Beovu that can be dosed once every eight weeks. However, treatment was associated with higher rates of inflammation and immunogenicity, which may raise concerns with doctors and patients.
The market will become even more crowded with the entry of Lucentis biosimilars, with the first from Samsung Bioepis and Biogen due to arrive in June. This could make it as difficult for Roche to build market share as it will for Regeneron to retain it.
Bernstein analyst Ronny Gal wrote in a December note to clients that he expects competition to cut Eylea sales, which earned Regeneron about $6 billion in the U.S. last year, by nearly half.
Roche appears to be willing to compete on price, setting an annual list price of Vabysmo at $6,570 once patients are in the maintenance phase of one shot every four months. A Roche spokesperson said it was "lower in price than other FDA-approved injectable eye medicines to treat these conditions."
In a survey of ophthalmologists conducted by Bernstein, 51% of those with an opinion on Vabysmo believed its data were better than Eylea's, according to Gal. "We believe physicians will be initially careful with a new drug, but barring side effects, a fair assumption is that [Vabysmo] will be a meaningful competitor," he wrote.