pSivida (NSDQ:PSDV) touted results today from a Phase I safety and efficacy pilot trial of its sustained-release Durasert implant in patients with osteoarthritis of the knee.
The company’s Durasert tech, combined with an implantable device from the Hospital for Special Surgery, was designed to continuously deliver a low dose of dexamethasone into the knee joint. Six patients with osteoarthritis of the knee were followed throughout the study for six months.
Researchers collected average weekly pain scores and compared them against baseline survey values. They also evaluated the safety of the implant using serial radiographs and by measuring plasma dexamethasone concentrations.
On average, patients had a 3.8 point reduction in weekly pain by week 4 that did not diminish over the 24 week period, pSivida reported. Plasma dexamethasone levels were lower than those reported by other treatment methods and there were no adverse events, according to the company.
“This system has the potential to fill a much-needed therapeutic gap for knee OA patients,” principal investigator Dr. Mark Figgie said in prepared remarks.
“This is a very promising start of a collaboration, combining the know-how, experience and technology of the pSivida team with the clinical expertise and insight of HSS. With the ageing and more active population, we are in need of novel and perhaps superior treatment alternatives for pain relief in arthritis,” Dr. Robert Hotchkiss, co-inventor of the implant & medical director of innovation at HSS, added.
“The positive Phase I data demonstrates that Durasert technology has applications beyond our core back-of-the-eye disease markets,” Nancy Lurker, pSivida’s president & CEO, said. “We believe patients suffering from severe knee OA deserve better non-narcotic, non-opioid options to help manage their pain, and our collaboration with HSS to apply our technology to these patients has the potential to provide longer-term relief of their pain.”
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