Roche’s implant for chronic eye disorder wins US approval

Swiss drugmaker Roche Holding AG (ROGS) said on Friday that the US health regulator has approved eye transplants for patients with a chronic disorder with blurred vision, allowing them to replace existing treatments. Also got the option of getting monthly eye injections.

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

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

Anti-vascular endothelial growth factor (anti-VEGF) therapy, the current standard of care for wet AMD, works against a protein that plays a key role in the disease and gives patients as many times as monthly to preserve vision. Eye injections are required.

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

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

“The device will be the first of its kind to replace the current standard of care injection for patients with wet AMD,” Roche chief medical officer Levi Garraway said in an interview with Businesshala ahead of approval.

Garvey said the device has an exchange mechanism that simultaneously refills a new batch of medication while the residual drug is removed.

UBS analyst Michael Luchten estimates the US market size for AMD to be around $3.5 billion.

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

Lucentis was first approved for wet AMD in the United States in 2006. Other anti-VEGF treatments include Regeneron Pharmaceuticals’ (REGN.O) Ilia and Novartis’ (NOVN.S) Bevu. Businesshala