PASADENA, Calif.--(BUSINESS WIRE)--Calhoun Vision, the developer of groundbreaking ocular technology designed to allow cataract surgeons to adjust the power of a lens after implantation in the eye, has announced enrollment of the 300th patient in the Phase III clinical study of its Light Adjustable Lens (LAL®). The study, which is being conducted at 18 centers across the country, will include a total of 600 patients, with 400 implanted with the LAL and 200 implanted with a monofocal control lens of the surgeon’s choosing. Unlike traditional intraocular lenses, which are made of non-adjustable material, the LAL technology is designed to allow surgeons for the first time to change and customize the power of the lens after it has been implanted in the eye.
“I have had the chance to implant 29 Light Adjustable Lenses since becoming part of the trial, and I am amazed by the technology’s potential,” said Dr. Steven Vold, founder and CEO of Vold Vision, P.L.L.C. in Fayetteville, Ark. “Having the ability to adjust the power of the lens post-operatively is a real paradigm shift in lens implant surgery that may lead to significant improvements in the precision and customization of the procedure. If proven safe and effective, I think this could be a game-changer in terms of standard of care.”
The LAL is implanted in the same way as with standard cataract surgery, but because it is adjusted after implantation, the lens’ performance is not affected by variables such as wound healing and changes in lens position. The patient returns for one or two follow-up visits, during which the surgeon evaluates his or her vision and performs an adjustment to customize the lens to the individual patient. This is accomplished by exposing the lens to UV-light from a special light delivery device, which changes the shape and power of the lens. Once the desired visual target is achieved, the surgeon locks in the lens with a final light treatment to prevent any further power change.
“We have been diligently working on the research and development of this technology for more than a decade, so it is gratifying to achieve the halfway mark in our Phase III clinical trial,” said D. Verne Sharma, president and CEO of Calhoun Vision. “As our trial centers have continued to gain experience with the LAL, we have seen a rapid uptake in enrollment, which puts us right on track for completing enrollment within the next several months. We will continue to push toward FDA approval in the U.S. and demonstrate the value we believe this technology will bring for both patients and physicians.”
About Calhoun Vision
Calhoun Vision is redefining lens implant surgery by developing technology that enables surgeons to change the power of a lens after it has been implanted, for the purpose of providing unparalleled visual outcomes. The company develops intraocular lenses that, when combined with a custom-designed digital light source, are intended to enable the surgeon to modify intraocular lens power after implantation to the specific, individual visual needs of each patient. Calhoun Vision’s Light Adjustable Lens (LAL®) is CE Mark approved for use in Europe, and is commercially available to patients in Germany, the United Kingdom, France, Italy, Spain, Mexico and the Czech Republic. It is currently in the third phase of clinical trials before submission for marketing approval in the United States.
Caution: The Light Adjustable Lens (LAL) is an investigational device and is not approved or cleared for sale within the United States. Limited by Federal law to investigational use.