Just as first Lucentis biosimilar wins approval, Roche snags an OK for an easier route of administration
It’s been a month since the FDA cleared the first biosimilar to Roche’s blockbuster wet age-related macular degeneration (AMD) drug ranibizumab. But the pharma giant isn’t going down without a fight.
Roche’s Genentech got approval on Friday for a new ranibizumab administration route that will allow wet AMD patients to ditch their current monthly injections and opt instead for as few as twice-annual treatments.
The drug, marketed as Susvimo, is an ocular implant that delivers ranibizumab continuously. While other anti-VEGF drugs like Roche’s Lucentis (ranibizumab injection) need to be administered monthly, the Susvimo implant is inserted in the eye during a one-time outpatient procedure, and only needs to be refilled every six months.
If necessary, supplemental ranibizumab can be given to the affected eye while the Susvimo implant is in place, according to the pharma.
Lucentis was approved back in 2006 for wet AMD, a chronic eye disorder that can lead to blindness. AMD affects the macula, the part of the eye that provides sharp, central vision for activities like reading. Wet AMD is an advanced form of the disease, which affects about 1.1 million people in the US.
Susvimo’s approval was based on results from an open-label Phase III study, in which Susvimo was found to be non-inferior to monthly ranibizumab injections. Patients in the Susvimo arm gained an average of 0.2 eye chart letters in visual acuity from baseline compared with 0.5 eye chart letters for the monthly ranibizumab arm, Genentech said. And more than 98% of Susvimo patients went six months before their first refill.
While Lucentis raked in $1.61 billion last year alone, the wet AMD market is now a bit more crowded. Samsung Bioepis and Biogen snagged approval last month for the US’ first Lucentis biosimilar, Byooviz, in three indications including wet AMD. The long-acting market includes Regeneron’s Eylea, which is approved for a 12-week dose, and Novartis’s Beovu, whose label includes 8-week and 12-week regimens.
“Susvimo represents a major advancement in the treatment of retinal disease, and is an important new option for patients with wet AMD,” Carl Regillo, chief of retina service at Wills Eye Hospital in Philadelphia and an Archway study investigator, said 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.”
Genentech isn’t stopping here. It’s also testing nine-month refills of Susvimo, and conducting studies in diabetic macular edema (DME) and diabetic retinopathy without DME.