Asepticys Files 510k Submission With FDA for TriFlect Disinfection Technology

Asepticys announced the completion of multisite human clinical trials for Asepticys’ novel contact lens care solution containing TriFlect technology. The company has submitted a 510(k) application to the FDA. The clinical trials involved over 320 patients at 12 sites across the United States.

“Eye infection with contact-lens wearers is a growing problem,” Dr. Rebecca Metzinger, Chief of Ophthalmology at the Southeast Louisiana Veterans Healthcare System, said in a company news release. “According to figures from the Center for Disease Control, over one-third of the nearly 41 million adults wearing contact lenses each year have sought medical attention for an infection associated with the use of their lenses. So it’s not a surprise that clinicians at the Asepticys trial sites were incredibly enthusiastic about the performance of this newly developed TriFlect technology, as it provides a new standard for rapid disinfection of dangerous bacteria while increasing convenience for the patient.”

“TriFlect technology is a breakthrough in disinfection that’s poised to disrupt and become a new benchmark in the $1 billion U.S. contact lens care market,” Todd Rands, Chief Executive Officer at Asepticys, said in the news release. “The successful human clinical trials represent a major milestone for Asepticys. Once we have final marketing clearance from the FDA, we will quickly move forward with the commercial launch of this disruptive new product.”

“There hasn’t been enough innovation to combat the constantly evolving microbial threats all around us,” added Mr. Rands. “Asepticys’ highly effective TriFlect technology is fueling a pipeline of promising new infection-fighting products that raise the standards for safety and health in our homes and hospitals.”