ORLANDO -- SurgiLight, Inc., a leader in the development of laser systems for various ophthalmic applications, today announced the launch of the first U.S. clinical trial for laser reversal and treatment of presbyopia, using the Company's proprietary OptiVision system. The first trial was cleared this month by the Food & Drug Administration (FDA) under an Investigational Device Exemption (IDE). Presbyopia involves diminishing visual acuity affecting millions of individuals, usually over the age of 40, worldwide.
The company presented data to the FDA demonstrating measurable clinical successes over as long as two years at sites overseas and most recently in Canada, where that government's FDA equivalent has also sanctioned trials. Overall, trials outside the U.S. have indicated almost no regression after OptiVision surgery, with more than 80 percent of patients reading without glasses post-operatively.
The first U.S. patients have been treated at the state-of-the-art Las Vegas clinic of Jon L. Siems, MD, considered a pioneer in refractive surgery techniques, and principal investigator in a number of previous major trials for ophthalmic applications unrelated to SurgiLight. Among Siems' prior posts was the directorship of UCLA's Inland Laser Center.
According to Siems, the OptiVision procedure "went extremely well" with the first four patients in the trial. One woman who returned to her office that same afternoon said that she could now "read the small print without glasses for the first time in 12 years." A patient in her early 50s said that she was returning to school for a master's degree in education and was "looking forward to reading at the same speed as before I was forced to wear glasses."
Siems said the presbyopia reversal procedure was "easy to learn and very controllable. The improvement in reading immediately following surgery and the next day was astonishing."
He described the procedure as "eight tiny laser cuts in the white of the eye in order to expand the lens globe and enable the eye to again focus at different distances."
SurgiLight chairwoman and CEO Colette Cozean, PhD, herself holder of several medical laser patents, commented, "My personal observation of Dr. Siems' initial procedures in the past day or so brought home the reliability, repeatability and relative simplicity of this procedure in the hands of a skilled surgeon."
SurgiLight, Inc. is a leader in the acquisition and development of new laser technologies for ophthalmic applications, including lasers not only for presbyopia reversal and treatment, but also cataract removal and treatment of glaucoma and psoriasis, with 16 patents granted and 23 patents pending.
Source: PRNewswire