The ranibizumab ocular implant (Susvimo) for neovascular (wet) age-related macular degeneration (nAMD) will return to the U.S. market "in the coming weeks," Genentech announced.
The return follows a nearly 2-year hiatus resulting from a voluntary recall initiated after test results showed that "some implants did not perform to Genentech's standards." Specifically, the performance issue involved septum dislodgement, which according to the device's prescribing information, would interfere with normal functioning.
In announcing FDA approval of the reintroduction, company officials said updates to the device and refill syringe, as well as improvements in the manufacturing process, restored the device's function to expected standards.
"We are pleased to reintroduce Susvimo, a unique therapeutic approach shown to provide an effective alternative to regular eye injections by preserving vision with two refills per year in phase III study of patients with wet AMD," said Levi Garraway, MD, PhD, Genentech's chief medical officer, in a company statement. "Susvimo's return to the retina community reflects our unwavering commitment to provide innovative retinal treatments, and lays the groundwork for future advancements."
Prior to the recall, clinical trials showed similar vision outcomes between the ranibizumab implant, with refills every 6 months, and monthly intravitreal injections of the anti-VEGF agent. Assessment of patient-reported outcomes showed that patients overwhelmingly preferred the device and its reduced treatment burden over conventional injections. Studies ongoing at the time of the recall showed similar long-term outcomes compared with monthly intravitreal anti-VEGF injections.
The FDA approved the device in late 2021, about a year before the voluntary recall.
https://www.medpagetoday.com/ophthalmology/generalophthalmology/111004
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