Roche’s eye implant gains U.S. approval
Roche’s eye implant for treating a chronic disorder that causes blurred vision gained approval from the U.S. health regulator. With this novel surgically implantable device, patients can get rid of the monthly eye injections part of prevailing treatments.
The implant – Susvimo, is designed to treat neovascular or wet age-related macular degeneration (wet AMD), caused by fluid or blood leaks from abnormal blood vessels into macula – an area near the retina, causes wet AMD disorder.
By continuously administering the drug into the eye, Susvimo may benefit patients with nAMD to maintain their eyesight with as few as 2 injections annually.
The implant delivers a customized form of Roche’s drug – Lucentis (ranibizumab), an anti-vascular endothelial growth factor (anti-VEGF) treatment.
The prevailing standard of care for wet AMD is anti-VEGF therapy, which targets a protein thought to have a functional role in the condition. Susvimo, earlier named as Port Delivery System with ranibizumab, is the first and only FDA-authorised treatment for AMD that offers just 2 treatments yearly.
Susvimo is designed for patients who have earlier responded to a minimum of 2 anti-VEGF injections and is only administered twice annually, decreasing the treatment burdenon patients.
Susvimo, which includes the implanted device and medicine, will cost $9,250 for the first 6 months, and the cost of a refill would be $8,000 for every 6 months.
In the company’s late-stage study last year, over 98 percent of patients treated with the device were able to go 6 months without requiring a refill.
Levi Garraway, Roche’s chief medical officer, stated that this device would be a unique alternative to the presently used injections for patients with wet AMD.
According to Garraway, the implant’s exchange mechanism automatically refills a fresh batch of the drug while the remaining drug is being removed.
Michael Leuchten, a UBS analyst, stated that the AMD market in the United States is worth approximately $3.5 billion.
Susvimo’s authorization comes with a warning that the implant was linked to a 3-fold increase in eye infection endophthalmitis compared to monthly injections of Lucentis.