iStar Medical is seeing some positive long-term results from a clinical trial of the Miniject, a micro-invasive glaucoma surgery (MIGS) device.
The Wavre, Belgium-based company presented the results of the European STAR-II clinical trial at the virtual American Academy of Ophthalmology (AAO) annual meeting this past weekend.
The trial enrolled 29 patients with open-angle glaucoma in eight centers in France, Germany, and Spain. Patients will be followed for two years post-intervention.
At one-year follow-up, mean intraocular pressure (IOP) was 15.1 mm Hg, corresponding to a 38 percent reduction from medicated baseline IOP. Moreover, 45% of patients did not require any IOP-lowering medication one year after intervention (from a mean of 2.9 medications at baseline). In a posthoc analysis in medication-free patients, IOP was reduced further by 46% to 13.1 mm Hg at one year. There were no significant overall safety issues, nor concerns with corneal health.
"The STAR-II results at one year confirm Miniject is a remarkably effective treatment option for patients with glaucoma. It is encouraging to see that the positive six-month results have been sustained at one year," explained Professor Julián García-Feijoó from Hospital Clinico San Carlos, Complutense University, Madrid (Spain) and a STAR-II study investigator, who presented the data at AAO.
The firm said the STAR-II data was consistent with one-year outcomes from the first Miniject trial, STAR-I. Twenty-five patients were enrolled in STAR-1 and followed-up for two years. iStar said the results were published in the peer-reviewed British Journal of Ophthalmology (BJO).
COVID-19 has struck a hard blow to elective procedures like MIGS. Glaukos is at the forefront of the landscape and during its 3Q20 earnings call executives commented on the pandemic’s impact on procedures.
“… Patient-related and practice efficiency headwinds persist and there is a limit to how much the system can withstand from a COVID standpoint,” Tom Burns, president and CEO of Glaukos said according to a Seeking Alpha transcript. “We are monitoring what appears to be a second or third wave in the U.S. and Europe, in particular the response of governments and health care systems accordingly and any potential impact on our customers as we move forward.”
Burns added, “Things are not yet back to normal from a market perspective, but the trends were encouraging throughout the quarter into October.”