FDA Clears Rapid Test for Dry Eye Disease



The US Food and Drug Administration (FDA) has approved a rapid in-office test for diagnosis of dry eye disease called InflammaDry, the developer, Rapid Pathogen Screening Inc (RPS), of Sarasota, Florida, has announced.

InflammaDry detects the inflammatory marker matrix metalloproteinase-9, which has been shown to be consistently elevated in the tears of patients with dry eye disease.

The test uses a sample of tears and takes less than 2 minutes to complete, with results available in 10 minutes. This allows a treatment plan to be established with the patient during the initial office visit. The test displays a blue control line for a negative result or blue and red lines for a positive result.

“InflammaDry will help clinicians confirm the diagnosis of dry eye before the patient leaves their office, resulting in more timely and appropriate management of their disease,” Robert Sambursky, MD, chief executive officer, president, and chairman of RPS, said in a news release.

Reached for outside comment, Glenda Secor, OD, communications chair of the American Academy of Optometry, told Medscape Medical News, “This is a pretty good test. It delineates whether the eye doctor should use an anti-inflammatory drug like a steroid or Restasis [cyclosporine, Allergan] for the patient with dry eye, with pretty good reliability.”

Dry eye is a “common complaint,” she added, one that increases with age,” and all tools are valuable; professional judgment is still key in differentiating etiology and determining proper treatment plans to maximize outcomes,” Dr. Secor said.