Bionode, a startup affiliated with Purdue University, is preparing a clinical trial to assess their novel gold-trace contact lens for treatment of glaucoma.
The device is part of a noninvasive system that reduces eye pressure without surgery or daily medication, according to cofounder and company CTO Pedro Irazoqui, PhD, a professor of electrical, computer and biomedical engineering at Purdue.
"It's a complicated reaction but a simple device," said Irazoqui.
The technology uses an off-the-shelf contact lens customized to each wearer and enhanced with a thin, gold insert around the edge, which acts as a biocompatible electrode.
"That trace of gold receives an electromagnetic field that we transmit from a specially equipped pair of glasses to convert the field into a current. The current is then delivered to a very specific part of the eye's anatomy to achieve the desired therapy," Irazoqui said in a press release. "Our device can electrically stimulate the muscles around Schlemm's canal, the structure where fluid leaves the eye, to decrease the impedance to fluid flow and, thus, decrease pressure.”
Preliminary testing of the prototype was highly successful, with patients experiencing improvements within 10 to 15 minutes, and no reports of side effects thus far.
“What we’ve seen consistently, is that the pressure will go down by as much as 40% in 5 minutes, matching the results you would see in months of treatment with eye drops, which are the standard of care,” Irazoqui stated in a video.
Bionode is working to secure $1.5 million in funding to begin an efficacy and durability trial in 100 glaucoma patients. If that study, and subsequent evaluations in diverse cohorts prove successful, the company plans on applying for CE Mark approval and U.S. FDA de novo approval.