RVO advances PresbyLens into final phase of trial for treatment of presbyopia

Jun 12 2012

ReVision Optics®, Inc. (RVO), a leader in implantable inlay technology to treat presbyopia, announces the advancement of its proprietary product PresbyLens™ into the final phase of its U.S. clinical trial under an Investigational Device Exemption (IDE). PresbyLens is a clear, circular corneal inlay comprised of approximately 80% water and is less than half the thickness of a human hair.    

The Phase 3 clinical trial will evaluate the safety and effectiveness of the PresbyLens in improving near vision in subjects with presbyopia. In this prospective, multicenter trial, subjects will be implanted with the PresbyLens in their non-dominant eye.

"The PresbyLens is designed to reduce or even eliminate the need for reading glasses by microscopically changing the shape of the surface of one eye," said Roger F. Steinert, M.D., Medical Monitor for the PresbyLens clinical trial. "Subjects implanted with the PresbyLens in the Phase 1 and 2 portions of this clinical trial measured average improvements on a standard eye chart of approximately 5 lines in near visual acuities and approximately 1 to 2 lines in intermediate visual acuities. The average loss in distance vision was about 1 line in the treated eye, while the subject's distance vision binocularly remained at 20/20. Subjects in the Phase 1 trial have now been followed for more than two years and are demonstrating sustained visual acuity improvement and corneal health."

Dr. Steinert is chair of the Department of Ophthalmology at the University of California, Irvine, holds appointments as the Irving H. Leopold Professor of ophthalmology and professor of biomedical engineering, and serves as director of the University of California Irvine Gavin Herbert Eye Institute. He also is an associate editor of Ophthalmology, the journal of the American Academy of Ophthalmology, and serves on the Executive Committee of the American Society of Cataract and Refractive Surgery.

"It is extremely exciting to see patients who for years have not been able to read a book or their iPhone® without glasses, read shortly after receiving the PresbyLens. We call this the 'Wow Factor,'" said John T. Kilcoyne, RVO President and Chief Executive Officer. Early results from clinical testing indicate that the 15-minute outpatient procedure to implant the PresbyLens results in life-altering improvements within the first days. The benefits of this solution are evidenced by 95% of trial subjects voicing satisfaction with their outcomes. "We are delighted to be advancing PresbyLens into the final phase of clinical testing in the U.S.," added Kilcoyne.