Closely-held Clerio Vision hopes to begin proof-of-concept studies next year of a non-invasive, incision-less and tissue sparing vision correction laser technology that modifies the refractive index of the cornea.
“Our goal is a lunch time laser correction procedure that removes both the fear and potential risks of surgical intervention,” CEO, Mikael Totterman, says in an interview with BioTuesdays.com.
“This procedure can correct near- or far-sightedness, and since it does not remove any tissue, it can also be used to adjust other more invasive treatments such as cataract or LASIK surgeries,” he adds.
Laser surgery, such as LASIK, changes focusing power by changing the shape of the cornea using a laser to ablate and remove tissue layers in what’s known as a “flap and zap” procedure.
“What we do is dramatically different,” Mr. Totterman explains. “Our LIRIC (laser induced refractive index change) treatment alters the internal optics of the cornea, without cutting or removing tissue, to change the focusing power of the cornea. Since there is no flap cutting or ablation of tissue, LIRIC has much less potential for side effects associated with corneal flap such as dry eye, inflammation and infections.”
According to Mr. Totterman, 70% of adults in the U.S. require vision correction and more than 40% consider LASIK surgery but are either ineligible or afraid of eye surgery. Currently, there are some 700,000 LASIK procedures a year done in the U.S., representing only 2% of eligible patients.
LIRIC also has the potential to reach patients needing minor refractive correction following cataract surgery, which removes the natural lens of the eye and replaces it with an artificial intraocular lens (IOL) implant. There are three million IOL procedures annually in the U.S., and over 12 million procedures globally. Cataract surgery is one of the fastest growing surgical procedures due to an aging population and improved access to healthcare.
Mr. Totterman says these patients are usually not candidates for LASIK due to a high propensity for dry eye disease. “There is a need for refractive correction without the risk of dry eye,” he adds.
“The LIRIC procedure has the potential to reach an estimated 100 million people in the U.S. alone to correct a refractive error of less than three diopters, which is a treatment not well addressed by LASIK, expanding the current LASIK market by two-to-three times,” he contends.
In addition, Mr. Totterman says 17 million people globally have had LASIK and many will need revisions. “LIRIC is an ideal treatment for these revisions.”
He figures the company’s current addressable market is some $1.5-billion, with the potential to expand the market to $3.0-billion or more.
Clerio has attracted several key advisors to its team, including Dr. Scott MacRae, a top opinion leader in refractive eye surgery and a former member of the FDA Ophthalmic Devices Panel; and Charles Munnerlyn, who constructed the first working excimer laser system for vision correction in 1985 and was a founder of VISX, the world’s largest maker of laser-based vision correction system, which is now owned by Abbott.
LIRIC traces its history to an eight-year R&D collaboration between the University of Rochester and Bausch & Lomb, which hoped to position LIRIC as its next generation refractive platform.
However, the venture was cancelled after Valeant Pharmaceuticals acquired B&L in 2013. The IP, including more than 40 issued and pending patents, was returned to the university, which then licensed the IP to Clerio in 2014.
The company currently has a prototype system operating at the university and plans to manufacture several units in order to conduct human proof-of-concept studies in Canada next year with four-to-20 subjects.
Health Canada has classified LIRIC as a class 3 device, which has an approval pathway similar to the FDA’s 510(k).
In proof-of-concept studies with cat corneas, which are very similar to human corneas, a vision correction of one diopter has remained stable for two years. “Stability of the procedure is an important accomplishment,” Mr. Totterman points out. A diopter is a measure of the corrective power of a lens.
The company’s experiments also have demonstrated little cell impact in the epithelium, endothelium and retina of a cat eye, and no impact on the corneal nerves. The preclinical results were published in the peer-reviewed publication, IOVS, in July 2014.
Renowned LASIK surgeon, Dr. Jeff Machat, is collaborating with Clerio on its Canadian clinical program and is working on a plan to move quickly from proof-of-concept studies to Canadian approval studies.
Mr. Totterman says Clerio is considering a possible series B financing to accelerate Canadian approval of LIRIC. A series A financing last March was heavily oversubscribed and raised $3.7-million.
A study for European market clearance is also in the works ahead of U.S. studies seeking regulatory approval from the FDA. Mr. Totterman says the FDA has invited Clerio to participate in its “early feasibility program,” which is intended to facilitate the clinical evaluation of medical devices in the U.S.
“Our value proposition is to expand a refractive surgeon’s toolkit,” he says. “We have the potential to provide a pain-free treatment with an improved safety profile, reduced patient anxiety and multiple procedures over a patient’s lifetime.”