Susvimo was halted by Roche in mid-2022 due to manufacturing issues that prompted a market recall. Now, the therapy can be back on the market as the FDA has permitted the resumption of the treatment.
Susvimo is a refillable eye implant that only needs to be refilled twice a year as an alternative treatment to eye injections for wet AMD. Genentech and its parent company, Roche, ceased selling the unique drug delivery system in October 2022, as some implants failed to demonstrate the desired efficacy of Genentech’s commercialized products in tests.
Since then, the company said component-level updates have been made to the ocular implant and refill needle, eliminating any glitches, and the updates have been certified by the FDA.
According to the press release, Roche’s chief medical officer, Levi Garraway, said that Susvimo’s return to the retina community marked the ongoing dedication to delivering retinal treatments and creating further advancements. The company stated that the therapy will be made available in the coming weeks. The refillable implant, which was approved in 2021, is capable of delivering a planned formulation of ranibizumab from Genentech’s Lucentis after implantation surgery.
Susvimo was gradually progressing in its one year on the market before the pull. In the months preceding the recall, 76 interviewed ophthalmologists recognized the therapy as having a “much longer-lasting response” compared to the ophthalmology rival Eylea, made by Regeneron and Bayer. However, the majority in all nine domains “consistently” perceived Eylea as safer overall and more accessible.
Positioned as one of the world’s best-selling drugs with a portfolio of indications linked to eye diseases, Eylea is a formidable rival to overthrow. Other than Susvimo, Genentech is adapting well to the new challenge with its newly released ophthalmology giant, Vabysmo.
Eylea and Vabysmo have been in a heated battle since Genentech released the latter medicine into the market earlier this year. Ever since then, however, Regeneron’s and Bayer’s shares of Eylea have plunged for the first time in a while, but Vabysmo keeps climbing.
While the makers of Eylea obtained a nod for a high-dose formulation of the fast-selling drug last year, Vabysmo recently got one of its own with the FDA green light for a prefilled syringe form. The single-dose shot will benefit doctors as it is already prepared, unlike having the medication in the form of a solution from a vial.
In other cases, Genentech is developing a new drug candidate for wet AMD, which is “tailor-made” to be administered through the port delivery system applied within Susvimo.
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