AXIM Biotech develops rapid quantitative tear test for MMP-9, an inflammatory biomarker for DED

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The challenge has been in early detection of inflammation. Matrix metalloproteinase-9 (MMP-9), an inflammatory biomarker consistently elevated in the tears of dry eye patients, may accelerate early diagnosis when detected.

AXIM Biotechnologies, Inc. recently announced that it has successfully developed a rapid quantitative tear test for MMP-9, an inflammatory biomarker for Dry Eye Disease.

The company is an international healthcare solutions company targeting dry eye disease (DED), an under-diagnosed, though common disease, in part because symptoms do not always correlate with objective signs. DED has a highly variable symptom profile at different stages of the disease, and there is often a discordance between signs and symptoms.

The challenge has been in early detection of inflammation. Matrix metalloproteinase-9 (MMP-9), an inflammatory biomarker consistently elevated in the tears of dry eye patients, may accelerate early diagnosis when detected.

A patient can have severe symptoms yet show no sign of ocular surface damage, while others have advanced ocular surface damage, yet report no DED symptoms. This lack of correlation between clinical signs and symptoms of dry eye disease makes diagnosing and treating patients a challenge. Often, inflammation is present before the clinical signs of dry eye disease.

Dr. Joseph Tauber, AXIM’s Chief Medical Officer, underscored the importance as well as the challenge in accurately measuring levels of MMP-9 in a recent press release, saying, “The central role of inflammation in ocular surface disease is widely recognized, but our ability to measure this in the clinic has been limited to the InflammaDry test that measures tear matrix metalloproteinase (MMP) levels and provides a positive/negative result around a threshold of 40ng/ml of MMP-9. This ‘yes or no’ report has clinical value, but it is limited.”

He goes on to say, “Currently available MMP-9 testing does not detect a reduction in tear MMP-9 levels until the concentration drops below 40ng/ml and thus may miss clinically significant improvement that did not reach that threshold.”

More accurate pre-surgical and post-surgical outcomes are one of the clinical benefits of the quantitative test for MMP-9 used as a tool for accurate diagnosis of DED and subsequent treatment. Post-surgical complications, such as corneal wound healing, is facilitated by identifying dry eye prior to surgery.

“The availability of quantitative tear MMP-9 testing would be a significant advance in our ability to measure the degree of inflammation affecting our dry eye patients, allowing for more objective classification of their disease,” said Tauber. “Equally important would be the ability to measure improvement in control of inflammation that is the goal of many of our therapies for ocular surface disease, including pharmaceuticals, thermal pulsation treatments and even light-based therapies.”

John Huemoeller, AXIM’s CEO stated in the release: “Some reports indicate that nearly half of all U.S. adults experience dry eye symptoms and 33% of patients in eye care clinics present with complaints about dry eye. Given the size of the market, AXIM made the strategic decision to develop a test for MMP-9 to assist in early detection of dry eye disease. Together with our Lactoferrin and IgE Tests and now with the addition of our MMP-9 Test, AXIM will be positioned to corner the market for dry eye disease diagnostic testing.”