Business Essentials for Professionals


US FDA Approves Roche's Implant For Chronic Eye Disorder

US FDA Approves Roche's Implant For Chronic Eye Disorder
The United States Food and Drug Administration granted permission to Roche Holding AG for its eye implant used for treating a chronic disease that causes impaired vision. This will now provide patients with an alternative of having to take monthly eye injections under the currently available therapies for the disease.
Susvimo is a surgically implanted device designed for treating wet age-related macular degeneration (wet AMD), a medical condition that is caused by the leakage of fluid or blood from faulty blood vessels into the macula, a region near the retina within the human eye.
The design of the device is such that is continually provides a modified version of the Swiss company's anti-vascular endothelial growth factor (anti-VEGF) medication ranibizumab, marketed as Lucentis.
Under the current gold standard of therapy for wet AMD, anti-VEGF medications are put to use which targets a protein that is thought to have a critical role in the illness. To maintain the eyesight of a patient suffering from the disease, the current therapies require patients to have eye injections as frequently as once a month.
Patients who have had at least two anti-VEGF injections are the targeted users of Susvimo and this new medication is required to be given only twice a year instead of once a month. This will significantly bring down the treatment load on patients.
Susvimo, which comprises the implanted device and drugs, will cost $9,250 for the first six months, according to Roche. The cost of a refill is $8,000 every six months.
In the late-stage study of the therapy conducted by the company last year, more than 98 per cent of individuals who were treated with the device were able to go on for six months without needing a refill.
"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.
According to Garraway, the device of the treatment contains an interchange mechanism that automatically supplies a fresh batch of medicine as the remaining drug is removed.
AMD's market size in the United States is estimated to be around $3.5 billion, according to UBS analyst Michael Leuchten.
Susvimo's clearance comes with a caveat - the implant has been linked to a three-fold greater risk of eye infection endophthalmitis than monthly injections implemented for Lucentis.

Christopher J. Mitchell

Markets | Companies | M&A | Innovation | People | Management | Lifestyle | World | Misc