- Randomized, controlled clinical trial data on advanced dry eye patients from the OLYMPIA trial recently published in Clinical Ophthalmology
- Study authors concluded that the TearCare procedure delivered superior symptoms improvements over LipiFlow in patients suffering from advanced dry eye disease. These patients experienced significantly better symptoms improvements, quality of vision, and symptom frequency
MENLO PARK, Calif., Sept. 29, 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 today announced Clinical Ophthalmology has published data from a subgroup analysis of the OLYMPIA trial, which showed a single treatment with the TearCare System led to superior symptoms relief across the following primary symptoms endpoints (Ocular Surface Disease Index – OSDI, Symptom Assessment in Dry Eye – SANDE, Eye Dryness - ED) compared to a LipiFlow application in patients with more severe forms of DED due to meibomian gland dysfunction (MGD).1
“Since obstruction of the meibomian glands is the underlying cause of MGD or evaporative dry eye, thorough and comprehensive clearance of the obstruction and the restoration of gland health and meibum production is the preferred treatment. There are different technologies available to address MGD and the unique technological design and procedural differences will naturally impact clinical outcomes and success rates. OLYMPIA demonstrated that the differentiated TearCare technology delivers differentiated clinical outcomes,” said Preeya K. Gupta, M.D., Managing Director of Triangle Eye Consultants, Raleigh, N.C. and first author on the published OLYMPIA study. “We are pleased to see that not only was TearCare able to show a clinically meaningful benefit across all DED patients regardless of severity of disease, but it also demonstrated superior symptoms outcomes among those dry eye patients with advanced disease. The subgroup analysis within OLYMPIA confirms the consistently strong clinical outcomes that many clinicians and I are seeing in our dry eye patients treated with the TearCare System.”
The OLYMPIA study was a multicenter, masked, randomized controlled trial in which 235 participants received either a single TearCare treatment (n = 115) or a single LipiFlow treatment (n = 120) and were followed for one-month post-treatment. Signs and symptoms were assessed across widely accepted endpoints, including the Ocular Surface Disease Index (OSDI), Symptom Assessment in Dry Eye (SANDE), Tear Breakup Time (TBUT) and Eye Dryness (ED) questionnaires at baseline and at one month. At one month, both treatments demonstrated a statistically significant improvement in all primary and secondary endpoints.2
In the subset of more severe patients (MGSS <7) with similar OSDI baseline, those receiving TearCare treatment (n=56) achieved an OSDI score reduction of -31.0 versus -21.4 for those that received LipiFlow treatment (n=65), a statistically significant difference in OSDI symptoms improvements in favor of TearCare. The mean reduction from baseline in SANDE frequency scores also favored a TearCare reduction of 51.9 versus LipiFlow’ s 41.5, another statistically significant difference in favor of TearCare. In evaluation of the Eye Dryness Scores within this more severe subgroup, the authors reported the treatment effect of TearCare also trended in favor of TearCare with a mean ED score difference of 8.9 (p=0.071) when compared to LipiFlow.
“As payors evaluate appropriate coverage and reimbursement for select MGD treatments, like TearCare, that are being rigorously clinically evaluated through thoughtfully designed RCTs like OLYMPIA (TearCare/device vs LipiFlow/device) and Sahara (TearCare/device vs Restasis/drug), our patients currently paying out of pocket for heat and expression MGD treatment have high expectations for noticeable improvement,” said Marc Bloomenstein, O.D., Schwartz Laser Center. “The evidence provided in this OLYMPIA subgroup analysis reinforces my confidence in TearCare as my MGD treatment of choice across all patient populations, including the more challenging advanced dry eye patients. Hopefully these study results will encourage my colleagues to establish proficiency in meibomian gland expression following the delivery of therapeutic heat delivery to the eyelids.”
“We are encouraged by the superior clinical findings in this subgroup analysis of advanced dry eye patients from the OLYMPIA trial,” said Paul Badawi, CEO of Sight Sciences. “TearCare’s intuitive design enables clinicians to thoroughly and comprehensively address the root causes of the signs and symptoms of dry eye due to MGD and these data further confirm our confidence in the clinical and economic value that TearCare brings to patients, providers and payors. On the heels of the publication of this superior symptoms data from OLYMPIA, we also announced the completion of patient enrollment in Sahara, our second major RCT where we are comparing TearCare to the standard of care in dry eye, Restasis. We look forward to the readout of TearCare (device) vs Restasis (drug) in the summer of 2023.”
* LipiFlow is a trademark of Johnson & Johnson
References:
1. Holland EJ, Loh J, Bloomenstein M, et al. A comparison of TearCare and LipiFlow systems in reducing dry eye disease symptoms associated with meibomian gland disease. Clin Ophthalmol. 2022; 16:2861-2871. doi:10.2147/OPTH.S368319
2. Gupta PK, Holland EJ, Hovanesian J, et al. TearCare for the treatment of meibomian gland dysfunction in adult patients with dry eye disease: a masked randomized controlled trial. Cornea. 2022;41(4):417-426. doi:10.1097/ICO.0000000000002837
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 Company’s TearCare® System is 510(k) cleared 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 an eye care professional to address the leading cause of dry eye disease. For more information, visit www.sightsciences.com.
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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