Last Friday, October 22nd, the United States Food and Drug Administration (FDA) approved a first of its kind drug delivery device for individuals with wet age-related macular degeneration. This is a welcomed option for individuals suffering from the disease as current treatment involves monthly, physician administered, injections directly into the eye. This invasive and inconvenient treatment is difficult for many patients to maintain because of frequent disruptive trips to the doctor’s office. Conversely, the newly FDA-approved device only requires a visit to the doctor’s office once every six months.
The new device to treat wet age-related macular degeneration is called Susvimo. It was created by the biotechnology company Genentech and is an implantable device that can deliver the drug ranibizumab continuously for a period of 6-months. After the 6-month period, a patient would be required to return to their physician to receive a refill of the drug. The device is unique in that it is the size of a grain of rice and is implanted directly into the upper eyelid in a simple outpatient procedure.
The approval of the device is based on a recent clinical trial that evaluated the safety and efficacy of Susvimo. In the trial, patients with wet age-related macular degeneration were either implanted with Susvimo and treated with ranibizumab with refills every 6 months, or they were treated with monthly eye injections of ranibizumab. The results showed that the patients who received the implantation of Susvimo achieved and maintained vision gains at a similar rate as the individuals who received monthly injections. In other words, the Susvimo implant worked just as well as the monthly injections. Dr. Carl Regillo, Chief of Retina Service at Wills Eye Hospital, a lead investigator on the study, said, “with Susvimo, patients now have an option that can help maintain their vision […] but on a more manageable twice-yearly treatment schedule.”
Wet age-related macular degeneration is a severe eye disorder that often causes blurred vision and can lead to blind spots in the visual field. Roche, the parent company of Genentech, is hoping to reduce the burden of age-related macular degeneration patients with this device and with another drug in their portfolio. As reported last month, Roche is seeking FDA approval for its drug Faricimab that is aimed at treating age related macular degeneration. As such, there is great promise for the treatment of this vision impairing disease.