New therapy for wet AMD gains FDA approval
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Genentech announced the FDA has approved ranibizumab 100 mg/mL injection for wet age-related macular degeneration in patients who previously responded to at least two anti-VEGF injections.
Previously known as the Port Delivery System (PDS) with ranibizumab, the new therapy (Susvimo) is designed for intravitreal use via ocular implant for the treatment of people with wet, or neovascular, AMD.
This is the only FDA-approved therapy for wet AMD that offers as few as two treatments per year.
“Susvimo represents a major advancement in the treatment of retinal disease, and is an important new option for patients with wet AMD,” Ocular Surgery News Editorial Board Member Carl D. Regillo, MD, chief of retina service at Wills Eye Hospital, said in the release. “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.”
According to the release, Genentech’s newly approved treatment for wet AMD is an alternative to anti-VEGF eye injections, which are needed as often as once per month.
The approval is based on positive results from the ARCHWAY phase 3 study.
As Healio previously reported, the PDS continuously and reproducibly delivered ranibizumab over a period of 6 months or more and eyes treated with the PDS gained an average of 0.2 letters in visual acuity.
According to the release, the new treatment will be available in the U.S. in the coming months.
Perspective
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My experience as an investigator in the ARCHWAY clinical trial was positive. After the surgical procedure, I had patients who were absolutely thrilled not to be getting frequent injections and to have their disease under control. I also felt that learning the technique of the refill exchange procedure was more than an anti-VEGF injection but certainly within my skill set and a positive experience.
Patients absolutely love Susvimo. In the clinical trials, we conducted a patient preference questionnaire of patients who had experienced, on average, five anti-VEGF injections prior to receiving the drug delivery implant. When asked which they preferred, 93% of patients preferred Susvimo. That is pretty remarkable, but it completely reflects my own experience.
Susvimo gives patients disease control and maintenance of vision long term with two procedures each year, and that is exciting.
Susvimo is a great step forward for clinical practice. We spend a lot of time monitoring our patients. We know that 98% of patients did not need supplemental injections once they had Susvimo in place, so that will reduce monitoring and it absolutely reduces the injection frequency. It makes the office visits a whole lot more focused and easier.
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