Seven months after the FDA signed off on a reintroduction of Roche’s eye implant Susvimo, the U.S. regulator has broadened its label as a treatment for diabetic macular edema (DME), which is the leading cause of diabetes-related blindness.
The nod is the second indication for Susvimo, an alternative to regular eye injections that was originally approved to treat wet age-related macular degeneration in October 2021.
Twelve months later, however, Susvimo was pulled because of manufacturing problems with the seal on the port delivery device. By July of last year, Roche had ironed out the issues and earned endorsement from the FDA to put it back on the market.
Susvimo is the size of a grain of rice and is surgically implanted under the upper eyelid. The device provides a customized formulation of Lucentis (ranibizumab), which needs refilling just twice a year.
“I am excited to offer Susvimo to my patients living with diabetic macular edema who want an option with longer intervals between treatments due to their busy personal and professional lives,” Jordan Graff, M.D., a vitreoretinal surgeon at a Barnet Dulaney Perkins Eye Center in Arizona, said in a release.
The approval is based on results from a phase 3 study of more than 600 DME patients, which showed that Susvimo accomplished noninferior improvements in vision compared to monthly doses of Lucentis.
Roche has yet to reveal sales figures for Susvimo. On its first go-round on the market, the treatment had started to gain acceptance from ophthalmologists. A few months before its recall, a Spherix survey revealed that a “large majority” of eye doctors acknowledged the therapy’s “superior duration of response” compared to Regeneron and Bayer’s stalwart Eylea.
Since then, Roche’s Vabysmo—which was approved in 2022—has taken the market by storm, generating sales of 3.86 billion Swiss francs ($4.3 billion) in 2024, while sales of Eylea have fallen to $5.9 billion after peaking at $6.3 billion in 2022.
As for Susvimo, Roche’s pharma chief Teresa Graham said on an earnings call last week that approximately 100 implants were completed in 2024.
“In this stage of the launch, it’s all about getting new ophthalmologists exposure to Susvimo and trained on how to perform the implant and refill exchange procedures,” Graham added. “This is very much a story of going slow to ultimately go fast.”
DME affects approximately 29 million adults in the world, including 750,000 people in the U.S., according to Roche. It occurs when damaged blood vessels in the retina leak into and cause swelling in the macula, which is the central area of the retina responsible for the sharp vision needed for reading and driving.