FDA approve Susvimo for wet age-related macular degeneration
pharmafile | October 29, 2021 | News story | Medical Communications |
Genentech have announced that Susvimo, previously known as the port delivery system, is the fist wet age-related macular degeneration (AMD) device to be approved by the FDA. It contains ranibizumab, a monoclonal antibody fragment, and is a refillable, intravitreal implant surgically inserted into the eye during a one-time outpatient procedure. This procedure continuously delivers a customised formulation of ranibizumab over time.
The Susvimo eye implant is refilled every six months at fixed intervals, in comparison to standard-of-care eye injections needed as often as once a month. By continuously delivering medicine into the eye through a refillable implant, Susvimo may help people with AMD maintain their vision with as few as two treatments per year.
AMD is a common condition affecting vision, which without treatment can worsen – gradually over several years, known as ‘dry AMD’, or quickly over a few weeks or months, known as ‘wet AMD’. The exact cause is unknown, though it has been linked to smoking, high blood pressure, weight and family history. It is a common cause of visual impairment and blindness. A recent European study estimated that 67 million people in the European Union are currently affected by the condition.
The approval is based on positive results from the Phase I Archway study primary analysis. In the study, Susvimo was generally well-tolerated, with a favourable benefit-risk profile. The Susvimo implant has however been associated with a three-fold higher rate of endophthalmitis (brain inflammation causing flu-like symptoms) than monthly intravitreal injections of ranibizumab. Many of these events were associated with conjunctival retractions or erosions.
Genentech is a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. Other discoveries include the first targeted antibody cancer and the first medicine for primary progressive multiple sclerosis.
Ana Ovey
