Improvements in Signs and Symptoms of Dry Eye Disease From a Single TearCare® Treatment Sustained Through 12 Months

  • DATA PRESENTED AT THE 2022 AMERICAN ACADEMY OF OPTOMETRY MEETING
  • MEIBOMIAN GLAND FUNCTION IMPROVES BY 63% AND DRY EYE SYMPTOMS REDUCED BY 44% THROUGH 12 MONTHS

MENLO PARK, Calif., Dec. 08, 2022 (GLOBE NEWSWIRE) — Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on creating innovative solutions intended to transform care and improve patients’ lives, is pleased to report independent data addressing a frequent question from eyecare practitioners (ECPs) and patients regarding the treatment of meibomian gland disease (MGD) using the TearCare® System: How long does a single treatment last?

Clinical outcomes for 78 dry eye patients (156 eyes) treated at a single center, the Cleveland Eye Clinic, showcased the duration of efficacy of a single, first-time treatment of MGD using the TearCare® System and were presented by Thomas Chester, OD, FAAO at the 2022 American Academy of Optometry meeting. Patients throughout the study exhibited improved dry eye signs and symptoms for more than 12 months, and in some cases up to 18 months, post treatment. The study was a retrospective, investigator-initiated trial (IIT) reviewing clinical outcomes for patients who had been treated with the TearCare® system at least 12 months prior to data collection.

“These data showed that patients experienced a 44% decrease in dry eye symptoms from baseline to week 8, suggesting a fast onset of action from TearCare®, and this symptom reduction was maintained through month 12, further suggesting sustained long-term improvements associated with the use of the TearCare® System. In some patients, these therapeutic benefits were maintained through 18 months. This data should help provide both patients and practitioners with confidence that a single TearCare® treatment may improve a patient’s dry eye symptoms for substantive period of time after the procedure is performed,” said Thomas Chester, OD, FAAO. “In addition, treatment with TearCare® may help address poor patient compliance with daily prescription eye drop regimens – a common hurdle encountered when prescription eyedrops are the only treatment option provided.”

For this study, all patient data were collected from medical records retrospectively with no prospective intervention. Patients’ symptoms were assessed at a single time point pre-treatment and at four time points post-treatment (8-12 weeks, 6 months, 12 months, and 18 months). Patients treated with therapies other than TearCare® within the 12-month window, including ophthalmic prescription medications, were excluded. In total, data from 78 patients (156 eyes) who had been treated with the TearCare® system and who returned for post-treatment follow up were included in the analysis.

Results of the trial showed most subjects experienced at least 12 months of gland function improvement and decreased symptoms. Standard Patient Evaluation of Eye Dryness (SPEED) score data decreased approximately 6.2 points, from 14.1 ± 6.5 to 7.9 ± 5.7, at eight weeks after treatment and was maintained up to 12 months post-treatment, indicating a positive treatment outcome. In addition, the average meibomian gland expression (MGE) score increased 4 points post-treatment from baseline of 4.9 ± 2.6 in the right eye and 4.8 ± 2.4 in the left eye to 9.0 ± 2.7 (P <0.001) in the right eye and 9.0 ± 2.9 (P<0.001) in the left eye (measured at 8 weeks post-treatment) and remained at least 3 points higher from baseline over the course of a year with a month 12 score of 7.8 ± 1.7 (P <0.001) in the right eye and 7.8 ± 1.4 (P <0.001) in the left eye, again suggesting positive treatment outcomes in the signs of dry eye.  

“Sight Sciences is committed to redefining the treatment paradigm for dry eye, a disease that until now has primarily been treated by prescription eye drops and artificial tears,” said Paul Badawi, CEO of Sight Sciences. “Considering only approximately 5% of dry eye patients currently receive interventional MGD procedures such as TearCare® for the treatment of their dry eye1, we believe these clinical data demonstrate the durability of treatment effect with TearCare® and will support greater adoption of the procedure. Interventional procedures for dry eye not only address the often mismatched mechanism of action of commonly prescribed Rx that typically target aqueous deficiency when most dry eye patients are suffering from accelerated tear evaporation due to MGD2 but they also help address patient compliance issues and the high monthly costs of daily prescription medications. Since the use of the TearCare® System helps address the root underlying cause of obstructive MGD and evaporative dry eye, and since our growing body of clinical data suggest that such use confers durable efficacy advantages for many patients, we believe it will transform how dry eye is treated in the future.”

Our objective is that these long-term efficacy findings, along with the ongoing prospective SAHARA RCT (NCT04795752) directly comparing the TearCare® system with Restasis in the first ever large-scale device versus drug RCT, will provide payors with evidence in support of insurance coverage for TearCare® along with a provider reimbursement pathway.

References:

  1. Market Scope 2021: Ocular Surface Disease Survey
  2. Lemp MA, Crews LA, Bron AJ, et al. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012;31(5):472-478. doi:10.1097/ICO.0b013e318225415a

About Sight Sciences

Sight Sciences is an eyecare technology company focused on developing and commercializing innovative solutions intended to transform care and improve patients’ lives. Using minimally invasive or non-invasive approaches to target the underlying causes of the world’s most prevalent eye diseases, Sight Sciences seeks to create more effective treatment paradigms that enhance patient care and supplant conventional outdated approaches. The Company’s OMNI® Surgical System is a minimally invasive glaucoma surgery (MIGS) device indicated to reduce intraocular pressure in adult patients with primary open-angle glaucoma (POAG), the world’s leading cause of irreversible blindness. The SION™ Surgical Instrument is a bladeless, manually operated device used in ophthalmic surgical procedures to excise trabecular meshwork. The Company’s TearCare® System is 510(k) cleared in the United States for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), enabling office-based clearance of gland obstructions by physicians to address the leading cause of dry eye disease.

About the TearCare® System

The TearCare® System is FDA cleared and indicated for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction, when used in conjunction with manual expression of the meibomian glands. The TearCare® System is the only device designed to evacuate obstructed meibomian glands while harnessing a natural blink experience. The system is comprised of single-use, universally fitting SmartLids™ which are placed on the eyelids to deliver “intelligent therapeutic heat” safely and effectively. The portable SmartHub™ 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, the Clearance Assistant forceps allows the ECP to control expression of the stagnant, obstructed meibum expertly and precisely by targeting individual meibomian glands while obtaining full visual confirmation of the success of this personalized treatment.

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