SOUTH SAN FRANCISCO, Calif.—Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced on October 22 that the U.S. Food and Drug Administration (FDA) has approved Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for treating people with wet, or neovascular, age-related macular degeneration (AMD). The drug is approved for those who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections, according to the announcement.

Susvimo, previously called Port Delivery System with ranibizumab, is the first and only FDA-approved treatment 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,” said Carl Regillo, MD, chief of retina service at Wills Eye Hospital in Philadelphia and an Archway study investigator. “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.”

Susvimo delivers ranibizumab continuously, offering people living with wet AMD an alternative to anti-VEGF eye injections needed as often as once a month. 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.

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

Susvimo will be available in the U.S. in the coming months, according to Genentech. The company said it will be offering comprehensive services for people prescribed Susvimo to help minimize barriers to access and reimbursement. Patients can call 833-EYE-GENE for more information. For people who qualify, Genentech plans to offer patient assistance programs through Genentech Access Solutions. More information is also available at (866) 4ACCESS/(866) 422-2377 or on
Genentech developed the first anti-VEGF medicine that not only slowed the progression of wet AMD, but restored vision for many patients. Lucentis (ranibizumab injection) was first approved for wet AMD by the FDA in 2006.