ReVision Optics Advances PresbyLens into Phase 3 Clinical Trial for Improving Near Vision in Patients with Presbyopia

Patient Recruitment Now Underway

LAKE FOREST, Calif.--()--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.

The PresbyLens is a corneal inlay made of medical grade hydrogel similar to commercial contact lenses. The inlay is mostly water, as is the cornea, and has optical characteristics almost identical to the cornea. The PresbyLens, which has a diameter of only 2 millimeters, is bioengineered to facilitate transport of nutrients and fluid and is as transparent as natural tears.

Presbyopia is considered to be a natural part of the aging process and is believed to be caused by the gradual loss of elasticity of the eye’s lens, which decreases the ability to focus up close. The first symptoms usually occur between the ages of 40 and 50.

Participation in PresbyLens Clinical Trial

The Phase 3 PresbyLens clinical trial will be conducted at a number of specialized ophthalmology centers across the U.S. Subjects interested in participating in the IDE trial and to be referred to a participating treatment center are requested to complete a pre-screening questionnaire available on the ReVision Optics website at http://www.nearvisiontrial.com/pages/Do_You_Qualify.htm.

About ReVision Optics

ReVision Optics, Inc. focuses on the research and development of custom optical solutions dedicated to presbyopic vision correction. RVO’s first product is the PresbyLens* inlay, a unique patented refractive surgery solution. This inlay is designed to improve the near vision that has been lost by the eye’s natural aging process called presbyopia. The PresbyLens inlay is removable, and provides an ideally suited surgical option for near and intermediate vision enhancement.

The Company is actively pursuing regulatory approvals and market opportunities for the PresbyLens worldwide. The PresbyLens has its CE mark authorization and is approved for sale in Europe.

*CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.

Contacts

ReVision Optics, Inc.
John Kilcoyne
President & CEO
(949) 707-2740
jkilcoyne@revisionoptics.com
or
Media Contact
LHA
Jody Cain (jcain@lhai.com)
(310) 691-7100
@LHA_IR_PR

Sharing

Contacts

ReVision Optics, Inc.
John Kilcoyne
President & CEO
(949) 707-2740
jkilcoyne@revisionoptics.com
or
Media Contact
LHA
Jody Cain (jcain@lhai.com)
(310) 691-7100
@LHA_IR_PR