Going Small with Big Results: The VisAbility Micro-Insert System

The VisAbility Micro-Insert from Refocus Group is the first and only presbyopic procedure performed outside the visual axis.

by Jennifer Zweibel

In May of this year, Refocus Group (Dallas, TX) announced that it had completed enrollment of its Phase 3 clinical trial on the VisAbility™ Micro-Insert System for presbyopia. Ralph Chu, MD, medical director and founder of Chu Vision Institute in Minneapolis, MN, presented his early, positive results of the trial at the 2016 annual meeting of the American Society of Cataract and Refractive Surgery (ASCRS) in New Orleans, LA.

As the only presbyopic procedure performed outside the visual axis, the VisAbility™ Micro-Insert System could be an attractive option for many people affected by presbyopia, which causes the inevitable loss of near vision around the age of 40. Nearly 90 million Americans and 1.7 billion people worldwide have presbyopia.

Shortened Trial Time

“When I joined the company 2.5 years ago, I assumed we were just about ready to launch,” said Mike Judy, CEO, at the Ophthalmology Innovation Summit at ASCRS 2016. “But it turned out the instrumentation hadn’t been perfected, and we didn’t have a recognizable group of investigators.”

So Judy restarted the iterative process of refining the instrumentation and simultaneously petitioned the FDA about shortening the required trial time. Given the substantial clinical trial history and previous data on the device, the FDA granted Refocus Group a 12-month follow-up for approval as opposed to the normal 24.

“A Prospective, Multicenter Clinical Trial of The VisAbility™ Implant System for Improvement of Near Visual Acuity in Presbyopic Patients” has enrolled a total of 360 subjects between 45 and 60 years of age at 13 clinical sites in the US. Refocus Group plans to submit for FDA premarket approval in 2017.

How It Works

The VisAbility™ procedure is performed on both eyes in an outpatient setting with topical anesthesia and consists of inserting four, micro-thin inserts, each smaller than a grain of rice, just below the surface of the sclera. The inserts are essentially unnoticeable to others under conditions of normal gaze.

Perhaps most importantly, because the procedure is performed in the sclera, the VisAbility™ Micro-Insert doesn’t alter the cornea or natural lens, which not only preserves the quality of the patient’s vision at all distances but also will not interfere with any future refractive or cataract procedures.

“From a surgeon’s perspective, everything in our hands right now involves surgical modification to the visual axis,” said Dan Tran, MD, founder and medical director at Coastal Vision Medical in Orange County, CA. “Once you do that, it’s irreversible. Some of the inlays can be removed, but we’re still modifying the cornea centrally. So when I was presented with this procedure, I was very impressed with the fact that it’s outside the visual axis. Nothing will prevent the surgeon from doing further procedures. For younger patients, replacing the entire lens is traumatic. This is a procedure that enhances the patient’s vision and still leaves them with options for future.”

Mitigating the Fear Factor

“Fear is still a major obstacle to surgery,” Judy said. “The VisAbility procedure is designed to eliminate a lot of that anxiety. Patients know that it’s reversible. By the time these individuals are ready for cataract surgery, in 15 or 20 years, having previously undergone the VisAbility procedure will not affect their candidacy. In addition, if any new technology becomes available in the interim, the patient will have a better chance of being eligible because the cornea and lens have not been altered.”

According to Dr. Tran, two factors correlate with happiness in presbyopic patients: quality of vision, and the ability to see near. “Problems with either of those factors diminishes patient satisfaction. This procedure has no effect on distance vision, so it fulfills both patient needs,” said Dr. Tran, who is overseeing one of the final clinical sites.

“So far, the patients I have seen have been very happy, and the surgery has been relatively simple,” Dr. Tran noted. “We have seen very few complications — no glare or halos.”

Early Results

According to the data Dr. Chu presented at 2016 ASCRS, 95% of the Phase 3 trial subjects represented achieved distance-corrected visual acuity of 20/40 (J3) or better at 6 months in their dominant eye, with an average of 3.2 lines of improvement. Perhaps more impressive, at least from a patient perspective, is the fact that 100% of the subjects that Dr. Chu treated achieved an uncorrected visual acuity of 20/40 (J3) or better at 6 months in both eyes.

“The presbyopic inlays that are available are only implanted in one eye. In my experience, patients understand that both eyes have difficulty reading and need improvement. One of the very attractive features of the VisAbility Micro-Insert is that it improves near vision in both eyes,” Dr. Chu said.

Also, the VisAbility Micro-Insert does not seem to negatively effect distance vision. “Patients in the trial have been very happy not only with their significantly improved binocular near vision, but also with the fact that their distance vision has been unaffected,” Dr. Chu said.

Looking Forward

Refocus plans to have the 1-year follow-up completed in March 2017 and is hoping for approval in the first half of 2018.

“I don’t see much downside to the insert,” Dr. Tran said. “The only exception is that it’s a surgical procedure, so some risk-averse patients won’t do it, but anyone seeking surgical intervention to treat their presbyopia, is a good candidate.”

Anyone that doesn’t have cataracts and has a clear cornea with no scarring is a good candidate, according to Dr. Tran. As long as the crystalline lens is still functional, the procedure will work. It may also be an option for patients with pseudophakic accommodating lenses.

The biggest impediment to surgeons in adopting new procedures is usually the initial cost of investment, but according to Mr. Judy, all the surgeon will really need is the company’s customized scleratome and alignment system.

Disclosures: Dr. Chu and Dr. Tran are clinical investigators for Refocus.