Roche’s implant for chronic eye disorder wins FDA approval

October 22, 2021

By Amruta Khandekar and Bhanvi Satija

(Reuters) -Swiss drugmaker Roche Holding AG said on Friday the U.S. health regulator approved its eye implant for patients with a chronic disorder causing blurred vision, giving them an alternative to receiving monthly eye injections with existing treatments.

Roche’s Susvimo is a surgically implantable device intended to treat wet age-related macular degeneration (wet AMD), a disorder which occurs when abnormal blood vessels leak fluid or blood into an area near the retina called the macula.

The device is designed to continuously deliver a customized version of the company’s drug ranibizumab, branded as Lucentis, which is an anti-VEGF therapy.

Anti-vascular endothelial growth factor (anti-VEGF) therapies, the current standard of care for wet AMD, work against a protein said to play a key role in the disease and require patients to receive eye injections as often as monthly to preserve vision.

Susvimo, which is intended for those who have previously responded to at least two anti-VEGF injections, needs to be taken only twice a year.

More than 98% of patients treated with the device were able to go six months before needing a refill in the company’s late-stage study last year.

“This device will be a first-of-its-kind alternative to the current standard of care injections for patients with wet AMD,” Levi Garraway, Roche’s chief medical officer, said in an interview with Reuters before the approval.

The device has an exchange mechanism that simultaneously refills a new batch of medicine while the residual drug is removed, Garraway added.

UBS analyst Michael Leuchten estimates that the U.S. market size for AMD is roughly $3.5 billion.

Susvimo is also being reviewed for the treatment of wet AMD by the European Medicines Agency (EMA), the company said.

Lucentis was first approved for wet AMD in the United States in 2006. Other anti-VEGF therapies include Regeneron Pharmaceuticals’ Eylea and Novartis’ Beovu.

(Reporting by Amruta Khandekar and Bhanvi Satija; Editing by Aditya Soni and Maju Samuel)

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