The Ireland-based company said it is 27 months into the 3-year trial which it hopes will support US FDA Premarket Approval, and that so far, 100% of subjects in the trial have completed their 18 month post-op visit.
The company’s lens is intended to correct presbyopia, farsightedness that is often age-related. Presbia’s custom lenses are implanted in the patient’s non-dominant eye in the hopes of helping the patient see near objects more clearly. To place the microlens in a patient’s eye, a small pocket is created in the cornea using a femtosecond laser and following the implantation, the pocket seals naturally and the lens sits at the center of the visual axis.
The Flexivue lens was developed to take advantage of binocular vision – when patients use both eyes and the images are fused in the brain, according to Presbia.
Data from the trial indicated that subjects treated with the microlens gained an average of 5 lines of uncorrected near visual acuity, with approximately 82% of subjects achieving 20/40 or better uncorrected distance vision, with little or no change in binocular uncorrected vision. A total of 98% of subjects achieved 20/40 or better corrected vision.
The company said that results cannot guarantee whether it will obtain PMA approval from the FDA, according to a press release.