Refocus announced that it has submitted its final module to the FDA for premarket approval of the VisAbility Micro Insert System for presbyopia.
The VisAbility Micro Insert System is the first and only presbyopic procedure performed outside the eye’s line-of-sight, developed to restore near vision without any compromise to distance vision or depth perception, a potential drawback of other presbyopic treatments, according to Refocus. The VisAbility procedure is performed in the sclera, so it does not alter the cornea or natural lens, preserving the eye for future refractive or cataract procedures.
The VisAbility procedure is performed on both eyes and consists of inserting four, micro-thin inserts, smaller than a grain of rice, just below the surface of the sclera. The inserts are so small they can’t be felt, and are unnoticeable to others in normal gaze. The outpatient procedure is performed with topical (eye drop) anesthesia.
“The VisAbility procedure will be a true practice builder in the treatment of presbyopia,” Frank A. Bucci, Jr., MD, founder of Bucci Laser Vision, and a principal investigator in the VisAbility clinical trial, said in a company news release. “The micro inserts do not alter the cornea or crystalline lens, yet they effectively restore the eye’s natural ability to bring near vision back into focus. There’s a generation of people who can benefit from this new technology, and we look forward to offering it.”
“Consistent with FDA’s modular premarket approval process, we have submitted all of our clinical and other data on VisAbility, and look forward to final FDA review,” Martin A. Kaufman, Chief Regulatory Officer at Refocus Group, said in the news release.
“The VisAbility Micro Insert System is one of the most thoroughly studied presbyopic treatments in ophthalmic history,” said Mike Judy, CEO for Refocus Group. “The promise of a treatment that offers all the gain of presbyopic correction, without the compromises of other treatments, kept investigators intrigued as we continued to improve the technology and evolve the technique.”
The VisAbility Micro Insert System has been refined with considerable advancements to both the design and surgical technique that have made the procedure faster and more precise. Investigators report a procedure time of under 20 minutes, with the measurements and data collection required for the trial.
“It has been a long journey to develop one of the most promising, least-invasive presbyopic procedures in ophthalmology,” said Mr. Judy. “We are very much looking forward to the anticipated FDA approval.”