Presbia Coöperatief U.A., an early-stage company focused on surgical solutions for presbyopia, today announced that it will unveil a breakthrough implantable micro-lens treatment for presbyopia at the European Society of Cataract and Refractive Surgery Congress (ESCRS) beginning Sept. 12 in Barcelona.
Presbia, formed in 2008 by the combination of Visitome and PresbiTech, will introduce its Flexivue System™. Offering a safe, effective, permanent yet reversible correction of presbyopia, Flexivue™ utilizes a unique implantable lens.
Clinical trials of Flexivue are expected to get underway in several European countries by the fourth quarter of 2009.
Presbyopia is the gradual loss of near vision that often accompanies advancing age. Fifty-five percent or more of those over the age of 30 in the Americas, Asia and Africa have some degree of presbyopia, with women affected more often and more severely, according to a study published by the Wilmer Eye Institute of Johns Hopkins University. The typical treatment is the use of reading glasses or contact lenses.
Presbia Chief Executive Officer Zohar Loshitzer said, “We are confident that Presbia has the key elements for success. We are well capitalized, have an experienced management team, offer leading-edge ophthalmic technology, and have aligned ourselves with the world’s finest minds in refractive surgery.”
Initial development of the implantable lens was conducted by Visitome, with major advances in the design, technology and implantation done after Visitome became part of Presbia. Presbia’s Chief Technology Officer Vladimir Feingold, who also led the project at Visitome, holds a few dozen patents on various medical-related advances.
The revolutionary surgery involves the placement of the Flexivue lens, which is just three millimeters in diameter and less than 20 microns in edge thickness, within the corneal stroma. The lens is made of hydrophilic polymer, similar to that used for the manufacture of intraocular lenses for the past 20 years. The lens is placed in a “pocket” created in the cornea by the same kind of laser routinely used for LASIK surgery. The eye surgeon inserts the lens into the pocket using a special device developed by Presbia.
The pocket then seals itself, holding the lens in place in the center of the pupil. The lens can stay in place permanently, or can be easily and safely removed if, for example, the patient’s presbyopia advances and a stronger prescription is required. The procedure typically takes less than 10 minutes, is performed on the non-dominant eye, and does not require anesthesia. A video of the procedure is available at www.presbia.com/demo.
Because the Flexivue lens is implanted using standard LASIK lasers, the procedure requires no additional capital investment from the surgeon’s practice.
Presbia has established a Medical Advisory Board, which is headed by Prof. Ioannis Pallikaris of the Institute of Vision and Optics of the University of Crete. Dr. Pallikaris, widely regarded as the “father” of LASIK surgery, has agreed to oversee trials of the Flexivue lens and to conduct training session for surgeons at his Institute. Other members of the panel will be named shortly.
Prof. Pallikaris stated: “Presbia offers a unique technology that provides the patient with correction for nearsightedness while allowing the dominant eye to continue to provide effective distance vision. Most importantly, this is a very simple and reversible procedure. Long-time research and follow-up has proven the highest level of bio-compatibility of this miniature intracorneal lens.”
The Flexivue lens will be manufactured for Presbia by Israel-based Hanita Lenses, whose facilities have earned CE and ISO approval. Presbia’s manufacturing process was designed to allow high-precision production in facilities around the world.