Sight Sciences Gets FDA Clearance of TearCare System for Treatment of DED

Sight Sciences Gets FDA Clearance of TearCare System for Treatment of DED

December 23, 2021

Sight Sciences reported that the TearCare System has received FDA 510(k) clearance for the treatment of meibomian gland dysfunction (MGD), the most common cause of dry eye disease (DED).

The indication clears TearCare for the application of localized heat therapy in adult patients with evaporative DED due to MGD, when used in conjunction with manual expression of the meibomian glands.

MGD, which is present in the majority of DED cases, is mostly untreated, and there are currently no approved treatment options that can address MGD as the root cause of dry eye.

The TearCare System offers safe and effective localized heat therapy with manual gland expression to soften or liquify thickened meibum and allow for adequate gland evacuation.

The TearCare System's innovative design delivers a consistent, requisite level of therapeutic heat (45 degrees Celsius) to the outer surface of the eyelids in order to achieve and maintain an inner eyelid temperature of 41-42 degrees Celsius, which is required to melt meibum.

Clinical Studies

The FDA clearance is based on data from multiple studies of the TearCare System, including recent safety and effectiveness clinical data from the pivotal OLYMPIA study published in Cornea.

At 1 month post treatment in the OLYMPIA study, patients who received a single TearCare procedure showed significant improvements (P < 0.0001) in mean tear film breakup time and meibomian gland secretion score, which increased by 3.0 ± 4.4 seconds and 11.2 ± 11.1, respectively.

TearCare subjects also showed significant reductions in mean eye dryness, Symptom Assessment in Dry Eye (SANDE), and Ocular Surface Disease Index (OSDI) scores (P < 0.0001) by 35.4 ± 34.1, 38.2 ± 31.0, and 27.9 ± 20.5, respectively.

In the study, 72% of TearCare patients showed OSDI improvement by at least one severity category, and 81% of TearCare patients met Miller’s definition of clinically meaningful improvement in OSDI.

“With such a significant number of DED cases caused by MGD, clinicians need a safe and effective modality to treat underlying meibomian gland obstruction in these patients,” Preeya K. Gupta, MD, Managing Director of Triangle Eye Consultants and lead author of the OLYMPIA study, said in a company news release.

“While historic treatments for dry eye, such as artificial tears and prescription eye drops, help address symptoms of dry eye and other potential causes, treatments for MGD remain an essential therapy for our dry eye patients. The OLYMPIA study further validates the safety and efficacy of the TearCare System to treat MGD, and we are excited to offer our patients an FDA-cleared option that can help clinicians clear gland obstructions and deliver better outcomes for adult MGD patients.”

About The TearCare System

The TearCare System consists of a reusable hardware controller, the SmartHub, and a software-controlled eyelid technology called the SmartLids. The SmartLids are applied adhesively and noninvasively to the outer surface of the eyelids and provide a universal and comfortable fit to deliver therapeutic heat within a tight therapeutic temperature window to the inner eyelid.

The SmartHub system provides sensor-driven feedback to manage consistent heat of the SmartLids, and is designed to be portable and work into any office patient flow.

The TearCare System leverages an open-eye design that allows patients to blink naturally throughout the procedure. Sight Sciences plans to continue research efforts to help support future indications for the TearCare System and to provide additional randomized, controlled clinical data, which the company believes could help support insurance coverage for the procedure in the future.

“The entire Sight Sciences community is committed to advancing treatment for MGD patients and expanding much needed patient access to insured treatment,” said Paul Badawi, Co-Founder and CEO, Sight Sciences.

 “MGD is the leading cause of DED and can present serious complications for patients if left untreated, yet both the understanding and treatment of MGD as the underlying cause of dry eye is still evolving. We remain dedicated to bringing an insurance recognized treatment option to the millions of underserved patients living with MGD.”