ReVision enters into final phase of PresbyLens trial

Medical Device Daily
The Daily Medical Technology News Source

By OMAR FORD
A Medical Device Daily Staff Writer

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.

One company said it has a technology that can help aid patients suffering from this condition.

ReVision Optics (RVO; Lake Forest, California), a developer of implantable inlay technology to treat presbyopia, announces the advancement of its PresbyLens into the final phase of its U.S. clinical trial under an investigational device exemption. PresbyLens is a clear, circular corneal inlay comprised of about 80% water and is less than half the thickness of a human hair.  The Phase III 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.

“We just started Phase III and we probably have another three years or so plus, with the recruitment and follow-up that we’re required to do for the IDE [before this can be eligible for approval] on the market,” John Kilcoyne, RVO president/CEO told Medical Device Daily.

“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 Steinert, MD, medical monitor for the PresbyLens clinical trial. “Subjects implanted with the PresbyLens in the Phase I and II portions of this clinical trial measured average improvements on a standard eye chart of approximately five lines in near visual acuities and approximately one to two lines in intermediate visual acuities. The average loss in distance vision was about one line in the treated eye, while the subject’s distance vision binocularly remained at 20/20. Subjects in the Phase I trial have now been followed for more than two years and are demonstrating sustained visual acuity improvement and corneal health.”

Steinert is chair of the Department of Ophthalmology at the University of California (Irvine), holds appointments as the Irving Leopold Professor of ophthalmology and professor of biomedical engineering, and serves as director of the University of California Irvine Gavin Herbert Eye Institute.

“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,’” Kilcoyne said. “Early results from clinical testing indicate that the fifteen-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.”

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.

The device has CE mark, and there is a very specific approach in launching the device in Europe, Kilcoyne told MDD.

“We’re picking positions rather than just going out and doing a [broad scale launch],” he said.

In 2010 the firm garnered some substantial funding.

Three years prior, the firm reported raising $25 million in a Series D financing (Medical Device Daily , May 1, 2007). That financing was led by Domain Associates, with additional investments from existing investors Canaan Partners and InterWest Partners. Brian Dovey, partner at Domain, joined the company’s board.

Omar Ford, 404-262-5546;
omar.ford@ahcmedia.com