Roche to reintroduce eye implant med Susvimo 2 years after recall

08 Jul 2024
www.fiercepharma.com
Roche to reintroduce eye implant med Susvimo 2 years after recall
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Source: FiercePharma
Susvimo is meant to provide continuous dosing of Roche's Lucentis.
Roche's launch of eye implant Susvimo was stopped short in 2022 after manufacturing concerns led to a market withdrawal. Now, with the FDA’s blessing to reintroduce the therapy, the rollout can resume.
Susvimo, a refillable eye implant that only requires two refills per year, offers an alternative to standard-of-care eye injections to treat wet age-related macular degeneration (AMD). Genentech and parent company Roche pulled the unique drug delivery system from the market in October 2022 after test results showed “some implants did not perform to Genentech’s standards,” according to a recent press release.
The drugmaker has since ironed out the kinks and made FDA-approved “component-level updates” to the ocular implant and refill needle, the company said.
“Susvimo’s return to the retina community reflects our unwavering commitment to provide innovative retinal treatments, and lays the groundwork for future advancements,” Roche's chief medical officer and head of global product development, Levi Garraway, M.D., Ph.D., said in the release.
The company will work to make the therapy available in the coming weeks, it said.
The refillable implant was approved in 2021 and provides continuous delivery of a customized formulation of ranibizumab, the active ingredient in Genentech's Lucentis, after a surgical insertion.
In its one year on the market before the pull, Susvimo was slowly gaining ground. Spherix analysts polled 76 ophthalmologists a few months before the recall, finding that “the large majority” of eye doctors acknowledged the therapy’s “superior duration of response” compared to Regeneron and Bayer’s ophthalmology stalwart Eylea.
Still, most respondents “overwhelmingly" viewed Eylea "as safer overall and more accessible,” according to the report.
As one of the world’s top-selling drugs armed with a clutch of eye disease indications, Eylea makes for a tough competitor to displace. Aside from Susvimo, Genentech is rising to the challenge with its blockbuster ophthalmology launch Vabysmo.
Eylea and Vabysmo have been duking it out since Genentech introduced the latter drug in 2022. Since then, Regeneron and Bayer have seen Eylea sales decline for the first time, while Vabysmo is still on the up-and-up.
While the Eylea makers won approval for a high-dose formulation of the blockbuster last year, Vabysmo just recently secured an upgrade of its own with FDA approval of a prefilled syringe version. The single-dose shot will give doctors a ready-to-use option as opposed to extracting the med from a vial.
Elsewhere, Genentech is working on a new candidate for wet AMDAMD that is “specifically designed” to be compatible with the port delivery system used in Susvimo. The molecule is currently in early development.
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