Combined Cataract And Presbia Microlens Surgeries Demonstrate Excellent Results And Patient Satisfaction In Near-Vision Improvement

Results Highlight the Effectiveness of the Presbia Microlens as a Solution to Independence from Reading Glasses

DUBLIN--(BUSINESS WIRE)--Presbia PLC (NASDAQ: LENS), an ophthalmic device company and leader 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.

“Presbia Flexivue Microlens offers a safe, effective, quick and easy to implement solution to near-vision loss and the need for glasses. 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”

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.

“Presbia Flexivue Microlens offers a safe, effective, quick and easy to implement solution to near-vision loss and the need for glasses. 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 the Company is pursuing its commercial strategy outside of the U.S. with a focused approach of activities taking place in South Korea, which will demonstrate the superiority, safety, and efficacy of Presbia's Microlens technology, and is preparing for commercial expansion in Germany in the next year.

Author contributions include Nela R. Stojanovic, MD, MSc, FEBO, Institute of Vision and Optics, Medical School, University of Crete; Vladimir Feingold; and Ioannis G. Pallikaris, MD, PhD. Dr. Pallikaris is the Medical Advisory Board Chair and Mr. Feingold is Executive Vice President of Presbia Coöperatief U.A. Dr. Stojanovic has no financial or proprietary interest in the materials presented in the article, and as of the date of this press release is no longer with the University of Crete.

Forward-Looking Statements

This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Information provided and statements contained in this press release that are not purely historical are forward-looking statements. Such forward-looking statements only speak as of the date of this press release and Presbia assumes no obligation to update the information included in this press release. Statements made in this press release that are forward-looking in nature may involve risks and uncertainties, including, but not limited to, the factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q. Accordingly, readers are cautioned that any such forward-looking statements are not guarantees and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Although Presbia believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Unless otherwise required by law, Presbia also disclaims any obligation to update its view of any such risks or uncertainties or to announce publicly the result of any revisions to the forward-looking statements made in this press release.

About Presbia

Presbia PLC (NASDAQ:LENS) is an ophthalmic device company that has developed and is currently marketing the presbyopia-correcting Presbia Flexivue Microlens™, a miniature lens that is implanted in a corneal pocket created by a femtosecond laser. The Presbia Flexivue Microlens™ has received a CE mark for the European Economic Area, allowing the lens to be marketed in over 30 countries across Europe. A staged pivotal U.S. clinical trial for the Presbia Flexivue Microlens™ commenced in 2014.