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FDA approves Susvimo continuous drug delivery implant for AMD

Genentech Susvimo

The US Food and Drug Administration (FDA) has approved the Susvimo implant which delivers ranibizumab continuously, offering patients living with neovascular age-related macular degeneration (nAMD) an alternative to more frequent anti-VEGF eye injections.

Genentech’s Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant has been approved for the treatment of nAMD in patients who have previously responded to at least two anti-VEGF injections.

Previously called Port Delivery System with ranibizumab (Lucentis), the implant is the first and only FDA-approved treatment for nAMD that offers as few as two treatments per year.

The European Medicines Agency (EMA) is also currently reviewing the implant for the treatment of nAMD.

Dr Carl Regillo, chief of retina service at Wills Eye Hospital in Philadelphia, said Susvimo represents a major advancement in the treatment of retinal disease, and is an important new option for patients with wet AMD.

“With Susvimo, my patients now have an option that can help them maintain their vision as well as anti-VEGF injections, but on a more manageable twice-yearly treatment schedule,” he said.

Regillo is also an investigator in the Archway study, the results of which the FDA’s approval is based.

The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every six months. If necessary, supplemental ranibizumab treatment can be given to the affected eye while the Susvimo implant is in place.

Dr Levi Garraway, chief medical officer and head of global product development, said Susvimo’s approval builds on Genentech’s long-standing commitment to people living with vision-threatening conditions.

“We believe that Susvimo can help people with wet AMD preserve their vision while potentially alleviating the treatment burden associated with current standards of care,” he said.

Genentech said the FDA’s approval is based on positive results from the Phase 3 Archway study primary analysis, which showed wet AMD patients treated with Susvimo achieved and maintained vision gains equivalent to monthly ranibizumab injections at weeks 36 and 40 of treatment. In addition, only 1.6% of Susvimo patients received supplemental ranibizumab treatment before their first refill, and more than 98% could go six months before their first refill.

However, the Susvimo implant has been associated with a three-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. In clinical trials, 2% of patients receiving an implant experienced at least one episode of endophthalmitis.

Susvimo will be available in the United States in the coming months.

Speaking about tackling treatment adherence in AMD as part of Macula Month in May last year, vitreoretinal ophthalmologist Associate Professor Andrew Chang, medical director of the Sydney Retina Clinic, said optimal visual outcomes of intravitreal therapy in the long-term depends on continuous monitoring and treatment, and optimising adherence and compliance.

“We’re now individualising treatment, it’s more nuanced with drugs that can last longer, potentially reducing treatment for some patients to six-monthly injections.”

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