Sight Sciences, a medtech company based in California, specializes in devices to treat glaucoma and dry eye disease. The company has recently announced FDA 510(k) clearance for the TearCare System, a device designed to treat meibomian gland dysfunction.
Meibomian glands are present near the rims of our eyelids and they secrete a clear oily substance called meibum that helps to lubricate the eye and reduce the evaporation of tears. When these glands get blocked, as they do in cases of meibomian gland dysfunction, they can no longer secrete meibum. Such blockages are a leading cause of dry eye disease.
The TearCare System has been created to deliver localized and accurate heating to the eye lids, helping to melt the blockage in the underlying meibomian glands. This allows an ophthalmologist or optometrist to manually express the glands using forceps. The company reports that the treatment leads to significant improvements in patients with dry eye disease.
Medgadget had the opportunity to speak with Dr. Reay H. Brown, Chief Medical Officer at Sight Sciences, about the technology. Â Â Â Â
Conn Hastings, Medgadget: Please give us an overview of dry eye disease and its consequences for patients.
Reay Brown, Sight Sciences: Dry eye disease (DED) is one of the most common reasons a patient visits an eyecare provider, with 44 million people in the United States alone affected by symptoms of dry eye. For the majority of these patients, DED is due to obstructive meibomian gland dysfunction (MGD), a chronic medical condition caused mainly by obstructed meibomian glands.
Meibum, a clear, oily secretion that is expressed through the meibomian glands (oil producing glands within each of the four eyelids), works to coat the outermost surface of the eye (ocular surface) and protects tears from premature evaporation. In MGD, there is abnormal thickening or hardening of meibum, and the opening of meibomian glands become blocked by stagnant meibum, preventing new healthy meibum from reaching the tear. Patients with obstructive MGD often experience inflammation, pain, and ocular surface damage, which can greatly impair their vision and quality of daily life.
Medgadget: How is the condition currently treated?
Reay Brown: In the past, treatments for DED have been focused on adding lubrication to tears, applying at-home warm compresses to the eyelids and, recently, on controlling inflammation with daily prescription eyedrop medications. However, this approach only addresses a sliver of the problem and fails to address underlying meibomian gland obstruction, which we know is the major root cause of the problem in the large number of patients with DED. For the preponderance of patients presenting with DED, it’s time to move from mere palliative care to a therapeutic model that focuses on both obstruction removal and inflammation control.
Medgadget: What inspired Sight Sciences to develop a treatment for dry eye disease?
Reay Brown: At Sight Sciences, we believe in designing, developing, and commercializing intelligently designed interventional solutions that allow eye care providers to comprehensively, intuitively, and procedurally intervene at the underlying root causes of the world’s most prevalent eye diseases. When it comes to DED specifically, prior treatment options aren’t today’s adequate solutions. If lubrication, at-home warm compresses and inflammation control were the answers to DED, then practices wouldn’t continue to see such a high volume of its patients returning, complaining of the same symptoms, and still seeking relief from this chronic disease.
We know, for patients with DED, the underlying cause of their symptoms is more than just inflammation, and in fact, the majority of DED is MGD and MGD is obstruction. Data consistently demonstrates that evacuating blocked meibomian glands has a more direct effect on the disease than initially treating with anti-inflammatory drugs, and by removing obstruction, you can restore the production and flow of healthy meibum secretions needed to ensure tear film stability, protect the ocular surface from damage, and reduce disease severity.
Obstructive MGD is a real disease that causes real problems, and we knew we had an incredible opportunity to transform the treatment paradigm for millions of patients suffering from DED due to obstructive MGD. With our TearCare® System, we aim to remove all obstructions to MGD treatment that are keeping patients from receiving the care they need and deserve.
Medgadget: How does the TearCare System work? Please give us an overview of the technology.
Reay Brown: The TearCare® System is the only device designed to evacuate obstructed meibomian glands in treating MGD while harnessing a natural blink experience. The system is comprised of single-use, universally fitting SmartLidsTM which are placed on the eyelids to safely and effectively deliver therapeutic heat for the optimal amount of time needed to melt stagnant meibum.
The portable SmartHubTM communicates directly with the SmartLids to precisely control the amount of phase transition heating and the duration of treatment. After 15 minutes of therapeutic heat to melt the gland obstructions, the Clearance Assistant forceps allow the eye care provider (ECP) to expertly and precisely control expression and evacuation of the stagnant, obstructed meibum by targeting individual meibomian glands while obtaining full visual confirmation of the success of this personalized treatment.
Medgadget: What is the system like to use? Is it something a dry eye patient would use regularly to keep their meibomian glands clear?
Reay Brown: The TearCare® System is intelligently designed to be portable and work into any office patient flow. The universally fitting SmartLidsTM allows the patient to blink naturally during the treatment, while the portable SmartHubTM allows patients to move around during their procedure, offering a flexible and comfortable treatment experience.
The entire TearCare® System procedure can be completed in a standard office visit by an ophthalmologist or optometrist and personalized to meet the needs of each individual patient. The frequency of treatment is currently based on practice of medicine, with no contraindication for multiple treatments.Â
Medgadget: Please give us an overview of the recent OLYMPIA study of the system.
Reay Brown: The OLYMPIA study, which was pivotal to our FDA 510(k) clearance, was a multicenter, investigator-masked, randomized controlled trial of the TearCare® System designed to demonstrate the safety and effectiveness of a single TearCare® procedure in the treatment of DED associated with MGD.
At one month post treatment in the OLYMPIA study, patients who received a single TearCare® System 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 reductions in mean eye dryness, Symptom Assessment in Dry Eye (SANDE), and Ocular Surface Disease Index (OSDI) scores. In the study, 75% of TearCare® patients showed OSDI improvement by at least one severity category.
Results from the OLYMPIA study were recently published in the journal Cornea.
Medgadget: Congratulations on receiving FDA 510(k) clearance for the system. What are the next steps for the technology?
Reay Brown: MGD is the leading cause of DED and can lead to 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. Today, there are limited to no insured treatment options currently available that can address MGD as the root cause of DED.
We remain dedicated to securing appropriate coverage and reimbursement for the TearCare® System for the millions of underserved patients suffering from obstructive MGD. We plan to continue research efforts to help support future indications for the TearCare® System and to provide additional clinical data from randomized, controlled studies, which we believe could help support insurance coverage for the procedure in the future.
Looking ahead, we are fully committed to ongoing innovation, continuous improvement in clinical outcomes, and always leading and improving the way through both new product innovations and future versions of existing products like our TearCare® System.
