Implant for Chronic Eye Disorder Wins FDA Approval

The U.S. Food and Drug Administration on Friday approved Swiss drugmaker Roche Holding AG’s eye implant for a chronic disorder causing blurred vision, most patients of whom currently have to receive monthly eye injections.

Roche’s Susvimo, previously called port delivery system (PDS), is a surgically implantable device designed to continuously deliver a customized version of the company’s drug ranibizumab, branded as Lucentis, over several months.

It removes the need for patients to receive injections of Lucentis, which is a standard of care for wet age-related macular degeneration (AMD) and is required at least every month to improve sight or prevent vision loss.

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

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.

Wet AMD occurs when abnormal blood vessels leak fluid or blood into an area at the center of the retina called the macula, and the risk of the disorder rises with age.

The number of people with AMD in the United States is expected to reach 5.44 million by 2050, according to the National Eye Institute.

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

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