Presbia, an ophthalmic device company specializing in near-vision restoration, announced the results reported in the May 2016 Journal of Refractive Surgery on combined cataract surgery and the implantation of the Presbia Flexivue Microlens as a solution to presbyopia, the age-related loss of near-vision. The results of the 12-month follow-up study after implantation of the Microlens showed excellent near-vision sharpness, high patient satisfaction and a high rate of independence from glasses after the procedure.
Outstanding results were reported for the Presbia Flexivue Microlens procedure that took place either before or after the cataract surgery, with the average uncorrected near-vision for patients at 20/25. This compares to an improvement in reading a 12-point font subhead in the newspaper to reading the content label at a 4-point font on a bottle of eye drops, without the use of glasses. Surgeons also reported no complications during or after the procedures for the 15 patients participating in the comparative study.
“We are pleased that the patients in the follow-up study have consistent results in their near-vision improvement, and are satisfied with their independence from reading glasses,” said Todd Cooper, President and CEO of Presbia.
Presbia is currently conducting a U.S. Food and Drug Administration (FDA) pivotal study of 421 subjects. All subjects completed their 6-month postoperative visits, a significant milestone in the FDA approval process. Concurrently Presbia is pursuing its commercial strategy outside of the U.S. with a focused approach of activities taking place in South Korea, and is preparing for commercial expansion in Germany in the next year.