Evolution Optiks Limited, a global leader in light field technology applications, announced today the completion of enrollment of the pivotal U.S. Food and Drug Administration (FDA) clinical study to evaluate the safety and efficacy of its subjective light field LFR-260 tele-phoropter (investigational device). Results from the study will be used in the submission to the FDA to support clearance that the company currently anticipates to receive in the middle of 2023.
This study was a multi-center, open-label 2×2 cross-over designed to investigate the effectiveness of the LFR-260 phoropter device compared to traditional phoropters. With the study concluded, we look forward to the final analysis and the subsequent opportunity to present the clinical and patient experience to the ophthalmic community,” says Dr. Anne Reuter, principal investigator of the study.
The LFR-260, a world-first subjective phoropter (investigational device) designed with a proprietary light field engine as its core, tele-operability, and unique capabilities such as QuadView™, is Evolution Optiks’ key product, within the newly launched Optokare division, focusing on eye care medical devices. It is intended to replace the memory-based, back-and-forth guessing that patients experience when obtaining their prescription, by providing up to four views at the same time, each with a slightly different prescription. In addition, its tele-operability is purposed to allow eye care practitioners to access patients in remote areas.
“We are delighted with how the study was conducted and would like to thank the patients, investigators and research teams who are participating in the LFR-260 study. Their hard work and dedication have resulted in a timely enrollment amid challenging circumstances presented by the COVID-19 pandemic. This speaks volumes about the interest to investigate the potential clinical benefits of our device,” comments Raul Mihali, President and Chief Executive Officer of Evolution Optiks.
Andreas Kusay, Chairman of Evolution Optiks, adds: “The regulatory clearance of the LFR-260 to be used as a tele-operable phoropter would add a very attractive solution to a rather stagnant market and unlock a significant addressable market expansion opportunity. With the completion of the enrollment phase, we look forward to shifting to the analysis phase of the study in anticipation of submitting the clinical data to the FDA.”