Jul 16 2014
Presbia Holdings, through its subsidiary PresbiBio LLC, announced today that it completed treatment of subjects in the first stage of its pivotal U.S. FDA IDE study of the Presbia Flexivue Microlens™.
Participating in the study are Dr. Kerry Assil, Dr. Michael Caplan, Dr. Michael Gordon, Dr. Robert Maloney, Dr. Robert Rivera, and Dr. Karl Stonecipher. “This is an exciting time for Presbia, the four week rapid enrollment reinforces high consumer demand for a presbyopia solution and adds to our investigator’s armamentarium,” said Zohar Loshitzer, President of Presbia.
“Patients are quickly deciphering the beneficial impact of this procedure. This is underscored by my observation that in all the years of conducting clinical trials, this is the first time that I have had two pair of spouses deciding to enroll in the same study. This type of organic enthusiasm suggests that the future opportunity for this investigational product could be immense,” said Dr. Kerry Assil, a principal investigator in the study.
The Presbia Flexivue Microlens™, as mentioned on NBC Los Angeles News, www.nbclosangeles.com/news/local/Breakthrough-May-Revive-Reading-Vision-266131821.html, would offer a solution for presbyopia, the loss of near vision that affects nearly all adults over the age of 40. Currently, the most common solution for presbyopia is reading glasses, but the Presbia Flexivue Microlens™, would be a customizable optical corneal inlay solution for presbyopia.
ABOUT PRESBIA AND THE PRESBIA FLEXIVUE MICROLENS™
Presbia Holdings is a leading ophthalmic-device company focused on the development of solutions for presbyopia, the age-related loss of the ability to read or focus on near objects. Chief among these approaches is the Presbia Flexivue Microlens™, a 3mm-diameter lens that is implanted in the corneal stroma of the patient’s non-dominant eye using femtosecond laser technology. The procedure requires no general anesthesia and typical recovery periods are only a few days. The Presbia Flexivue Microlens™ solution utilizes existing equipment and ophthalmic surgical techniques, and requires only minimal additional staff training. CAUTION Investigational device. Limited by Federal (or United States) law to investigational use.