New York City-based Hospital for Special Surgery and pSivida partnered to create a implant that improves knee osteoarthritis pain.
When asked about why pSividia partnered with HSS, Nancy Lurker, CEO of pSividia said, "The extensive expertise of HSS in the area of orthopedics. They are ranked number one in the U.S. and are trusted and respected in the area of orthopedics."
Here are five things to know:
1. The HSS-designed implant integrates pSivida's Durasert delivery technology to deliver patients a continuous low dose of dexamethasone into the knee joint for several months.
2. Recently, the two completed phase one of their safety and exploratory efficacy pilot study. Six patients, screened for radiologically-confirmed and symptomatic knee osteoarthritis, were included in the six month study.
3. Weekly pain scores were compared against baseline values using a survey of pain at rest, night and during activity on a zero to 10 scale. Patients underwent serial radiographs and plasma dexamethasone concentrations to monitor safety.
4. Researchers found, subjects experienced an average 3.8 point reduction in average weekly pain by week 4 that did not diminish over the 24 week period. Four patients were considered strict responders by week four while all six subjects were strict responders on weeks 12 and 24.
5. Additionally, plasma dexamethasone concentrations were found to be lower than those reported by other traditional treatments. No adverse events were reported.
Ms. Luker concluded, "The dexamethasone screw implant has the potential to provide longer term control of pain at a much lower dose of steroid. Zilretta data shows 12 weeks of pain relief. Current data from [the] phase 1 study with the dexamethasone screw implant shows six months of pain relief. There is also the
potential for longer pain relief as the implant lasts for one year."