pSivida, HSS start IND to study sustained-release implant for severe knee OA
pSivida Corp and Hospital for Special Surgery announced the initiation of an investigational new drug application to begin an investigator-sponsored clinical study of a sustained-release implant to treat severe knee osteoarthritis.
According to a press release, the device is designed to provide long-term pain relief for patients with severe knee osteoarthritis and will be implanted into the non-articulating part of the knee during an outpatient procedure. The study will evaluate the implant for 6 months, and the duration of release after a single treatment is expected to extend up to 1 year or more.
The open-label, single-dose, safety and tolerability study will assess the ability of the screw implant to administer dexamethasone. Each of the six patients will have the device implanted in one knee. Each week, investigators will assess change from baseline in mean of pain intensity scores at rest, with activity and at night through 24 weeks.
“We believe this product has the potential to provide long-term pain relief and to contribute to improved joint function for patients with severe osteoarthritis, which can delay knee replacement surgery,” Robert Hotchkiss, medical director of clinical research at Hospital for Special Surgery (HSS), said in the release. “Implanting a small, secure reservoir that delivers a corticosteroid on a sustained basis directly to the knee could avoid the issues with systemic steroid delivery and repetitive knee injections. This implant, the result of the combined insights [from] HSS and the expertise of pSivida, has the potential to create a paradigm shift in a variety of conditions.”