`
`Roche wins FDA approval for
`rival to Regeneron's lucrative
`eye drug
`Published Jan. 31, 2022
`
`Jonathan Gardner
`Senior Reporter
`
`Dive Brief:
`
`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.
`
`Dive Insight:
`
`Regeneron Exhibit 1195.001
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`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
`
`Regeneron Exhibit 1195.002
`Regeneron v. Novartis
`IPR2021-00816
`
`
`
`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.
`
`Regeneron Exhibit 1195.003
`Regeneron v. Novartis
`IPR2021-00816
`
`
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