Novel Port Delivery System With Ranibizumab Approved in Wet AMD

FDA recently approved a first-of-its-kind port delivery system (PDS) with ranibizumab, sold as Susvimo and developed by Genentech, in the treatment of patients with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least 2 anti–vascular endothelial growth factor (VEGF) injections.

Continuously providing 100 mg/ML ranibizumab injections intravenously via ocular implant, the treatment is the first and only FDA-approved treatment for wet AMD that requires as few as 2 treatments per year. The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every 6 months.

The decrease in required injections could prove a significant breakthrough in adherence for patients with wet AMD, a leading cause of blindness in people aged 60 and older that requires treatment with eye injections as often as once a month.

Notably, a recent study indicated that patients with proliferative diabetic retinopathy treated solely with ranibizumab were linked with significant lapses in care due to the frequency of treatment and monitoring visits associated with anti-VEGF therapies, which could lead to vision-threatening disease progression.

If required, supplemental ranibizumab treatment can be given to the affected eye while the ranibizumab PDS implant is in place.

“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 study investigator in the Archway trial, in a statement. “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.”

The approval is based on positive findings of the phase 3 Archway study primary analysis, which indicated that patients with wet AMD treated with ranibizumab PDS achieved and maintained vision gains equivalent to monthly ranibizumab injections at weeks 36 and 40 of treatment.

Moreover, only 1.6% of participants treated with ranibizumab PDS received supplemental ranibizumab treatment before their first refill, with greater than 98% of patients able to go 6 months before their first refill.

“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,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, Genentech, said in a statement.

Although well-tolerated with a favorable benefit-risk profile, the ranibizumab PDS implant has been associated with a 3-fold higher rate of endophthalmitis than monthly injections of ranibizumab. Further adverse events found in the Archway trial included conjunctival hemorrhage, conjunctival hyperemia, iritis, and eye pain.

Genentech is also currently investigating the efficacy and safety of Susvimo in the treatment of diabetic macular edema (DME), diabetic retinopathy without DME, and long-term wet AMD. Susvimo for the treatment of wet AMD will be made available in the United States in the coming months.