visual sciences, a California-based medtech company, specializes in glaucoma and dry eye treatment devices. The Company recently announced FDA 510(k) clearance for the TearCare System, a device for treating meibomian gland dysfunction.
Meibomian glands are located near the edges of our eyelids and secrete a clear oily substance called meibum that helps lubricate the eye and reduce tear evaporation. When these glands become clogged, as is the case with meibomian gland dysfunction, they can no longer secrete meibum. Such blockages are one of the main causes of dry eye.
The TearCare system is designed to provide local and precise heating to the eyelids, helping to melt the blockage in the underlying meibomian glands. This allows an ophthalmologist or optometrist to manually express the glands with forceps. The company reports that the treatment leads to significant improvements in dry eye patients.
Medgadget had the opportunity to speak with Dr. Reay H. Brown, Chief Medical Officer at Sight Sciences, to discuss the technology.
Conn Hastings, Medgadget: Please give us an overview of dry eye and what it means for patients.
Reay Brown, Vision Sciences: Dry eye disease (DED) is one of the most common reasons a patient sees an eye doctor, with dry eye symptoms affecting 44 million people in the United States alone. In the majority of these patients, DED is due to obstructive meibomian gland dysfunction (MGD), a chronic condition primarily caused by obstructive meibomian glands.
Meibum, a clear, oily secretion expressed by the meibomian glands (oil-producing glands in each of the four eyelids), works to coat the eye’s outermost surface (ocular surface) and protect tears from premature evaporation. In MGD, abnormal thickening or hardening of the meibum occurs and the opening of the meibomian glands is blocked by stagnant meibum, preventing new healthy meibum from reaching the rupture. Patients with obstructive MGD often experience inflammation, pain, and damage to the ocular surface that can severely impact their vision and quality of life.
Medgadget: How is the disease currently treated?
Ray Brown: Historically, treatments for DED have focused on smearing tears, applying warm compresses to the eyelids at home, and more recently controlling inflammation with daily prescription eye drops. However, this approach only addresses a fraction of the problem and does not address the underlying meibomian gland obstruction, which we know to be the root cause of the problem in the large number of patients with DED. For the vast majority of DED patients, it is time to move from purely palliative care to a therapeutic model that focuses on both obstruction clearance and inflammation control.
Medgadget: What inspired Sight Sciences to develop a treatment for dry eye?
Ray Brown: At Sight Sciences, we believe in the conception, development and commercialization of intelligently designed interventional solutions that enable ophthalmologists to comprehensively, intuitively and procedurally intervene at the underlying causes of the world’s most prevalent eye diseases. When it comes to DED specifically, previous treatment options are not today’s appropriate solutions. If lubrication, warm home compresses, and inflammation control were the answers to DED, then offices would not continue to see such large numbers of patients returning, complaining of the same symptoms and still seeking relief from this chronic disease.
We know that in patients with DED, more than just inflammation is the underlying cause of their symptoms, and indeed the majority of DED MGD and MGD is obstructive. The data consistently shows that evacuating blocked meibum glands has a more direct effect on the disease than initial treatment with anti-inflammatory drugs, and by clearing the obstruction you can restore the production and flow of healthy meibum secretions needed to to ensure tear film stability and protect the ocular surface from damage and reduce the severity of the condition.
Obstructive MGD is a real disease that causes real problems and we knew we had an incredible opportunity to change the treatment paradigm for millions of patients suffering from DED due to Obstructive MGD. With our TearCare® system, we aim to remove all barriers to MGD treatment that prevent patients from receiving the care they need and deserve.
Medgadget: How does the TearCare system work? Please give us an overview of the technology.
Ray Brown: The TearCare® System is the only device designed to evacuate clogged meibomian glands in the treatment of MGD while utilizing a natural blinking experience. The system consists of universally fitting, single-use SmartLidsTM that are placed on the eyelids to safely and effectively deliver therapeutic heat for the optimal amount of time needed to melt stagnant meibum.
The wearable SmartHubTM communicates directly with the SmartLids to precisely control the amount of phase transition heating and treatment duration. After 15 minutes of therapeutic heat to melt gland obstructions, the Clearance Assistant Forceps allows the ophthalmologist (ECP) to expertly and precisely control the expression and evacuation of stagnant, congested meibum, targeting individual meibomian glands while providing full visual confirmation of success this personalized treatment.
Medgadget: How is the system used? Is it something a dry eye patient would use regularly to keep their meibomian glands clean?
Ray Brown: The TearCare® system is intelligently designed to be portable and integrated into any patient flow in the office. The universally fitting SmartLidsTM allow the patient to blink naturally during treatment, while the wearable SmartHubTM allows patients to move around during the procedure, providing a flexible and comfortable treatment experience.
The entire process of the TearCare® System can be performed in a standard office visit by an ophthalmologist or optometrist and can be customized to the needs of each individual patient. The frequency of treatment is currently based on medical practice, with no contraindication to multiple treatments.
Medgadget: Please give us an overview of the current OLYMPIA study of the system.
Ray Brown: The OLYMPIA study, which was pivotal to our FDA 510(k) approval, was a multi-center, investigator-masked, randomized, controlled study of the TearCare® System designed to evaluate the safety and efficacy of a single TearCare® Method to demonstrate in the treatment of DED associated with MGD.
One month after treatment in the OLYMPIA study, patients who received a single procedure with the TearCare® System 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 increases, respectively, TearCare® subjects also demonstrated a reduction in Mean Eye Dryness, Dry Eye Symptom Score (SANDE) and Ocular Surface Disease Index (OSDI). In the study, 75% of TearCare® patients showed an OSDI improvement of at least one severity category.
Results of 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?
Ray Brown: MGD is the leading cause of dry eye and can lead to serious complications for patients if left untreated, however both understanding and treatment of MGD as the underlying cause of dry eye is still evolving. Today, there are currently no insured treatment options available that can address MGD as the root cause of DED.
We remain committed to ensuring adequate coverage and reimbursement for the TearCare® System for millions of underserved patients suffering from Obstructive MGD. We plan to continue research efforts to support future indications for the TearCare® System and to provide additional clinical data from randomized controlled trials that we believe could support insurance coverage for the procedure in the future.
Looking ahead, we are fully committed to continuous innovation, continuous improvement in clinical outcomes, and always lead and improve the path through new product innovations and future versions of existing products such as our TearCare® System.
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