Refocus Group announced that it has successfully completed its 12-month follow-up on 360 patients in its pivotal trial of the VisAbility Micro-Insert System for presbyopia. The announcement paves the way for preparation of Refocus Group’s premarket approval submission to the FDA.
The VisAbility Micro-Insert System is the first and only presbyopic procedure performed outside the eyes’ line-of-sight, developed to restore near vision without any compromise to distance vision or depth perception, a potential drawback of other presbyopic treatments. Because the procedure is performed in the sclera, the VisAbility Micro-Insert System does not alter the cornea or natural lens, so the eye is preserved for future refractive or cataract procedures.
“An early sample of consecutive cases treated by me and one other investigator (a total of 40 eyes of 20 subjects) showed that 100 percent of eyes had uncorrected near visual acuity of J3 (20/40) or better, 95 percent were J2 (20/30) or better, and 90 percent were J1 (20/25) or better, with no change in their distance vision at 12 months,” Frank A. Bucci, Jr., MD, founder, Bucci Laser Vision Institute, Wilkes Barre, Pennsylvania, said in a company news release. “My patients have been very satisfied with the range and quality of their vision, so I believe the VisAbility Procedure will be a valuable addition to our presbyopia correction armamentarium.”
Study investigators will present their initial findings at sessions during the ASCRS ASOA Symposium & Congress held by the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators at the Los Angeles Convention Center, 1201 S. Figueroa St., Los Angeles, Calif., May 5-9, 2017. One session, to be held as part of the new Industry Spotlight Theater, will include the VisAbility Micro-Insert System during a panel discussion on Presbyopia Correction, Monday, May 8, from 11 a.m. to 12 noon.
“The VisAbility Procedure doesn’t stop the clock from ticking, but it can turn back the hands so baby boomers can see near, again,” Mike Judy, CEO of Refocus Group, said in the news release. “We’ve seen promising outcomes that have kept investigators intrigued as the technology has improved and the technique evolved. A Refocus patient survey from an early FDA developmental study showed that 90.3 percent of patients reported their near vision was better or significantly better since the procedure.”
The current clinical trial, “A Prospective, Multicenter Clinical Trial of The VisAbility Implant System for Improvement of Near Visual Acuity in Presbyopic Patients,” enrolled a total of 360 subjects between 45 and 60 years of age, at 13 clinical sites in the United States. Given the substantial previous clinical trial history and data on the device, the FDA granted Refocus Group a 12-month follow-up for submission, versus the usual 24 months.
“It is so exciting to see a presbyopic alternative solution that does not involve visual compromise,” Dr. Selene A. Burke, Vice President of Clinical Affairs at Refocus Group, said in the news release. “Since the VisAbility Micro-Insert does not alter the cornea or crystalline lens, I believe it will be viewed as a true game changer in the treatment of presbyopia.”
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 designed to restore the eye’s natural ability to bring near vision back into focus. The inserts are so small they can’t be felt, and are unnoticeable to others in normal gaze. The VisAbility Micro-Insert System is performed as an outpatient procedure with topical (eye drop) anesthesia.