EYE DIAGNOSTICS

OVERVIEW

AXIM is working with four highly specialized point-of-care (POC) lab testing systems designed specifically to assist eye-care physicians in detecting and quantifying a variety of biomarkers associated with external ocular disorders. The first is a rapid Point-of-Care (10-minute) lateral flow diagnostic assay paired with a reader that tests for exact levels of Lactoferrin through the collection of 0.5 microliter in tears. The second test is designed for the measurement of Ocular Immunoglobulin E (IgE), a biomarker for allergies and a key biomarker primarily associated with Dry Eye Disease. Both tests are FDA-cleared and insurance reimbursable.

The third is a quantitative tear MMP-9 test is a significant advance to measure the intensity of inflammation affecting dry eye patients allowing for more objective classification the disease. The clinical benefits of the quantitative test for MMP-9 as a tool for accurate diagnosis of Dry Eye Disease and subsequent treatment include more accurate pre-surgical and post-surgical outcomes. Post-surgical complications, such as corneal wound healing, is facilitated by identifying dry eye prior to surgery.

Finally, the fourth and most recently announced test developed by AXIM is a rapid quantitative tear test for Lacritin, a tear protein that autonomously promotes tearing and is deficient in all forms of Dry Eye Disease.

BACKGROUND  

According to the American Academy of Ophthalmology, approximately 20 million people in the United States (344 million people worldwide) have Dry Eye Disease, and that number is growing in both young and old adults, making it imperative that clinicians figure out how best to diagnose and treat it.  According to the American Journal of Ophthalmology, as of July, 2017, a study reported an estimated 6 million people reported having experienced Dry Eye Disease symptoms but had never been diagnosed.

Diagnosing Dry Eye Disease is a challenge because it’s a multifactorial disease, with many disparate causes. It has a highly variable symptom profile at different stages of the disease, and there’s often a discordance between signs and symptoms.

CLINICAL NEED

Currently available tests for Dry Eye Disease include Matrix metalloproteinase 9 (MMP-9) testing which has been found to identify the presence of ocular surface inflammation in 40% of confirmed dry eye patients. However, some findings suggest that not all patients with symptoms and signs of Dry Eye have elevated MMP-9 levels. The other commonly used test is for Osmolarity.  Researchers have found that in a given patient, a single tear osmolarity measurement cannot be used to distinguish patients with dry eye from patients without Dry Eye. The variability among osmolarity readings calls into question its clinical utility. 

POINT-OF-CARE SOLUTION

AXIM is working with a rapid Point-of-Care (10-minute) lateral flow diagnostic assay together with a reader that tests for exact levels of Lactoferrin through the collection of 0.5 microliter in tears. Lactoferrin is a protein contained in tears, which protects the ocular surface with its antimicrobial and anti-inflammatory properties. Lower concentrations of lactoferrin have been demonstrated in patients with Dry Eye, which is associated with decreased aqueous tear production. AXIM’s scientific team has assisted in the optimization of the assay previously and continues to conduct research on its accuracy and applications. 

REIMBURSABLE TEST

AXIM is also working with a FDA-cleared, insurance reimbursable test for the measurement of Ocular Immunoglobulin E (IgE), a biomarker for allergies and a key biomarker primarily associated with Dry Eye Disease. The test is of high clinical utility in the confirmation of the presence of an active ocular allergen and uses the same reader system. AXIM’s scientific team is working on the optimization of the assay with an expected sales launch in the first quarter of 2022.

RENOWNED SCIENTIFIC MEDICAL ADVISORY BOARD

JOSEPH TAUBER, MD | CHAIRMAN

Dr. Tauber is the founder and CEO of Tauber Eye Center, a practice focused on corneal disease, uveitis and ocular immunology and complex corneal surgical procedures as well as Medical Director of Saving Sight, the US’ third largest eye bank.

Dr. Tauber has been centrally involved in virtually every significant dry eye development project during the past 25 years. He has served as a Principal Investigator in over 140 multicenter clinical trials including those that led to the approval of all four medications currently approved by the FDA for the treatment of dry eye – Restasis, Xiidra, Cequa and Eyesuvis. He has been avidly involved in research for nearly three decades, and a principal investigator in over 140 research studies across a broad range of eye conditions, including high-risk corneal transplantation, inflammation and allergic eye diseases, corneal infectious diseases and numerous ocular surface conditions.

Dr. Tauber received his doctorate from Harvard Medical School, residency training in internal medicine at Beth Israel Hospital and in ophthalmology at Tufts-New England Medical Center, and fellowship training in Ocular Immunology and in Corneal Diseases and Surgery at the Massachusetts Eye & Ear Infirmary, all in Boston, Massachusetts.
Dr. Tauber has also written eight book chapters and over 80 peer-reviewed articles in the fields of ocular surface and immunologic disease for prestigious medical journals as Ophthalmology, Investigative Ophthalmology and Visual Science, Journal of Cataract and Refractive Surgery and Cornea. He has been awarded the Heed Ophthalmic Foundation Fellowship Award and a National Eye Institute Individual NRSA Award.

DR. KELLY K. NICHOLS, O.D., M.P.H., Ph. D.

A founding member of the Ocular Surface Society of Optometry, Dr. Nichols currently serves as Dean of the School of Optometry at The University of Alabama at Birmingham. She is an acknowledged expert on DED and Ocular Surface Disease and has been extensively published. She earned her second B.S. and a Doctor of Optometry (O.D.) at UC Berkeley, and an M.P.H in biostatistics and a Ph.D. in Vision Science at Ohio State University. 

DR. LAURA M. PERIMAN, MD

Dr. Periman brings 30 years’ experience in medicine, the last 20 of which include her clinical practice specializing in ocular surface disease and dry eye disease (DED). She serves as Founder and Director of Dry Eye Services and Clinical Research of the Seattle-based Periman Eye Institute. Additionally, she has served as a principal investigator in ophthalmic clinical research primarily centered on ocular surface disease innovations including neural stimulation for treating DED, novel topical therapeutics as well as innovative procedures such as IPL, Radiofrequency and more.
 

DR. MICHAEL E. STERN, MS, Ph. D.

Dr. Stern brings over 30 years of senior scientific, research, academic and executive level expertise with Dry Eye Disease and Ocular Surface Disease (OSD). Currently, he is a Principal and Chief Science Officer for immunEyze, a boutique contract research organization that performs preclinical and clinical research for OSD indications. Previously, he served for 26 years with Allergan where he rose to Principal Scientist and Vice-President Inflammation Research whose work included elucidating the pathophysiology of DED. He is extensively published in leading ocular journals.