番茄社区

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 , would interfere with normal functioning.

In announcing , 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.

During the recall, additional options for longer treatment intervals emerged, notably high-dose aflibercept (Eylea HD) and faricimab (Vabysmo), said Richard Rosen, MD, PhD, of the Icahn School of Medicine at Mount Sinai in New York City. Both extend treatment intervals to 3 or 4 months, although the ranibizumab implant has achieved intervals as long as 9 months.

"[The implant] gives us one more option," Rosen told 番茄社区. "There are patients for which it will work well but I think that it's not going to work for everybody. As patients get older, putting an implant in has some increased risk because, basically, they don't have as much supportive tissue, so there's some risk to having any sort of prosthetic implant that could get infected or have tissue breakdown over it, although that's not really been an issue. We'll have to see what the response is in terms of everyone's comfort level."

Ongoing evaluation of anti-VEGF gene therapy could eventually lead to other options for long-term treatment, he noted.

"Still others are in the pipeline and could become available soon to help enable patients to live more normal lives without having to be in the doctor's office every month or 2 months, which is definitely a challenge for a lot of my patients," said Rosen.

Developing long-term treatment strategies with biologic agents also is challenging, particularly avoiding early breakdown that would interfere with the goal of sustained treatment effects, he added.

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