Optovue First in US to Receive FDA Clearance for Corneal Epithelial Thickness Mapping

Optovue Inc. has received U.S. Food and Drug Administration (FDA) clearance for its epithelial thickness mapping software (epi-mapping) for quantitative measurements of the epithelial and stromal layers of the cornea. Epi-mapping is the first non-contact, quantitative method for corneal epithelia and stromal measurements, and it is the first and only FDA-cleared product indicated to provide corneal epithelia and stromal measurements that aid in the diagnosis, documentation and management of ocular health and diseases in the adult population.
 
“The measurement of corneal epithelial thickness is becoming more recognized as a vital part of assessing patients for refractive surgery and following post-operative recovery, as well as managing patients with keratoconus or dry eye disease,” said George Asimellis, Ph.D., associate professor of optics and visual science at the University of Pikeville in Kentucky. “I use epi-mapping in my research protocols to scan patients that present with a corneal condition because any sign of an abnormality needs to be taken into consideration when performing other tests, as these tests will be influenced by epithelial irregularities. I believe epi-mapping will change the way we assess the cornea since it is a very reliable indicator of ocular surface health. This non-contact approach could easily become the standard-of-care for anterior segment eye exams because epithelial irregularities often mask stromal abnormalities.”

Asimellis is part of several research protocols to study how the epithelium is affected by various diseases and refractive procedures. He has evaluated thousands of corneal epithelial maps using Optovue’s epithelial thickness mapping software and he has been published in numerous peer-reviewed journals on its clinical applications.
 
“Optovue continues to lead innovation in Optical Coherence Tomography (OCT) imaging with the first non-contact technique of measuring the epithelial layer of the cornea,” said Jay Wei, founder and CEO of Optovue. “Our epi-mapping software has been the subject of more than 200 publications, underscoring its importance and value in the care of patients with corneal and ocular surface conditions. With epi-mapping, physicians are able to quantify epithelial thickness in patients in a manner that is suitable for daily clinical practice.”
 
In epi-mapping clinical studies, disruptions of the epithelial layer were found in patients with all stages of keratoconus, a progressive eye disease in which the normally round cornea thins and begins to bulge into a cone-like shape. An irregular epithelial layer was also observed in dry eye disease, which affects nearly 20 million people in the United States.¹ If left undetected, these conditions can adversely impact refractive surgery outcomes. Pre-surgical assessment with epi-mapping could help determine whether patients are suitable for refractive procedures. Finally, epi-mapping also provides important information about how the eye is healing after refractive and corneal surgery.
 
Optovue’s new mapping software provides epithelial thickness information in a fast, non-contact and easy exam. Traditional epithelial measurements require high-frequency digital ultrasound and saline. In addition, epi-mapping software complements other diagnostic tests by providing different information about ocular health that may be clinically valuable prior to testing such as topography and tomography, or topography-guided procedures including LASIK and PRK.

Optovue is a privately held medical device company founded in 2003. Headquartered in Fremont, Calif., the company develops and commercializes high-speed OCT and OCTA technology used to facilitate the diagnosis and management of eye diseases, many of which may lead to permanent blindness. Optovue is the first company to develop and commercialize the pioneering OCTA technology. To date, there are over 225 peer-reviewed publications detailing the AngioVue Imaging technology and clinical applications. The company has installed more than 11,000 products worldwide and employs over 170 people.

Reference
1. Gayton, J. Etiology, prevalence and treatment of dry eye disease. Clinical Ophthalmology. 2009; 3:405-12.