Susvimo, earlier known as Port Delivery System with ranibizumab, is said to be the first and only FDA-approved treatment for wet AMD that offers as few as two treatments per year
Genentech, a subsidiary of Roche Group, has received the US Food and Drug Administration (FDA) approval for its Susvimo (ranibizumab injection) to treat patients with wet, or neovascular, age-related macular degeneration (AMD).
Susvimo injection (100 mg/mL) has been designed for intravitreal use through the ocular implant to treat people with wet AMD and earlier responded to at least two anti-vascular endothelial growth factor (VEGF) injections.
Previously known as Port Delivery System with ranibizumab, Susvimo is said to be the first and only FDA-approved treatment for wet AMD that offers as few as two treatments per year.
Wet AMD is a potentially blinding condition that needs to be treated with eye injections as often as once a month. It is an advanced form of the disease, which can cause severe vision loss.
Roche said that Susvimo delivers the medicine continuously into the eye through a refillable implant and helps people with wet AMD maintain their vision with as few as two treatments in a year.
Roche chief medical officer and global product development head Levi Garraway said: “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.
“Susvimo’s approval builds on Genentech’s long-standing commitment to people living with vision-threatening conditions.”
The US regulator’s approval of Susvimo is based on positive results from the primary analysis of the Phase III Archway study.
The study revealed that Susvimo extended time between treatments up to six months for more than 98% of patients and provided vision outcomes equivalent to monthly ranibizumab injections.
Archway study investigator Carl Regillo 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.”