FDA OKs Sight Sciences’ TearCare for Meibomian Gland Dysfunction

Sight Sciences Inc., an eyecare technology company, announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the TearCare System for the treatment of meibomian gland dysfunction (MGD), the leading 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.
 
Present in the vast majority of DED cases, MGD is largely undertreated, with no insured treatment options currently available that can address MGD as the root cause of dry eye. Meibum, a clear, oily secretion that is expressed through the eye’s meibomian glands, works to coat the outermost layer of the eye and protect tears from premature evaporation. In MGD, there is abnormal thickening or hardening of meibum, and the opening of meibomian glands can become blocked, preventing meibum from reaching the tear. If left untreated, MGD can present serious consequences, including ocular surface damage, changes in tear film stability, inflammation, pain, chronic dry eye, and other symptoms that can greatly impair a person’s daily life and vision. The eye care community is increasingly acknowledging the importance of treating underlying meibomian gland obstruction when present for optimal treatment of DED associated with MGD.
 
The TearCare System provides safe and effective localized heat therapy, in conjunction with manual gland expression, intended to help soften or liquify thickened meibum for effective gland clearance. The TearCare System’s intelligent design delivers a consistent, requisite level of therapeutic heat (45 degrees Celsius) to the outer surface of the eyelids to achieve and maintain an inner eyelid temperature of 41-42 degrees Celsius—the inner eyelid temperature necessary to melt meibum. Research on the optimal melting temperature of hardened meibum suggests that precise heat delivery within this tight therapeutic temperature window is critical to achieving procedural safety and efficacy.¹ Efficacy lacks under 40 degrees Celsius at the inner eyelid, and heat exceeding 45 degrees Celsius at the outer eyelid can begin to present safety risks to patients.
 
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 one 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 percent of TearCare patients showed OSDI improvement by at least one severity category, and 81 percent 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,” said Preeya K. Gupta, MD, Managing Director of Triangle Eye Consultants and lead author of the OLYMPIA study. “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.”
 
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.”
 
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.

Reference
¹ Borchman D. The optimum temperature for the heat therapy for meibomian gland dysfunction. The Ocular Surface. 2019 Apr;17(2):360-364.