- 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 individuals suffering from advanced dry eye disease. These patients experienced significantly better symptoms enhancements, 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 in order to transform care and improve patients’ lives today announced Clinical Ophthalmology has published data from a subgroup analysis of the OLYMPIA test, which showed a single treatment along 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 inside patients with more severe forms of DED due to meibomian gland dysfunction (MGD). 1
“Since obstruction from the meibomian glands is the particular underlying cause of MGD or evaporative dry vision, thorough plus comprehensive clearance of the obstruction and the restoration of glandular health plus meibum production is the preferred treatment. There are different technologies available to address MGD and the particular 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. plus 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 sufferers regardless of severity of disease, but it also demonstrated superior signs and symptoms outcomes among those dry eye patients with sophisticated disease. The subgroup analysis within OLYMPIA confirms the particular consistently strong clinical results that many clinicians and I are seeing in our dry attention patients treated with the TearCare System. ”
The OLYMPIA study was a multicenter, masked, randomized managed 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 area Disease Catalog (OSDI), Symptom Assessment within Dry Vision (SANDE), Tear Breakup Time (TBUT) plus Eye Dryness (ED) questionnaires at baseline and at one month. At one month, both treatments demonstrated the statistically significant improvement in all main and secondary endpoints. 2
In the particular subset associated with more severe individuals (MGSS < 7) with similar OSDI baseline, those receiving TearCare treatment (n=56) achieved a good OSDI score reduction of -31. 0 versus -21. 4 with regard to those that received LipiFlow treatment (n=65), a statistically significant difference within OSDI symptoms improvements in favor associated with TearCare. The particular mean reduction from primary in SANDE frequency scores also favored a TearCare reduction of 51. 9 versus LipiFlow’ s 41. 5, another statistically substantial difference in favor of TearCare. In evaluation of the Eye Vaginal 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 remedies, 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 sufferers currently paying out associated with pocket regarding heat plus 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 out 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 with this subgroup analysis of advanced dried out eye individuals from your OLYMPIA trial, ” said Paul Badawi, CEO of View Sciences. “TearCare’s intuitive design enables clinicians to thoroughly and comprehensively address the particular root causes of the signs and symptoms of dry eye because of MGD and these data further confirm our confidence in the clinical and economic value that TearCare brings in order to patients, providers and payors. On the heels from the publication of this first-class symptoms data from OLYMPIA, we also announced the completion of patient enrollment in Sahara, our own second major RCT where we are comparing TearCare to the standard of treatment in dried out eye, Restasis. We look forward to the readout of TearCare (device) versus Restasis (drug) in the particular summer associated with 2023. ”
* LipiFlow is the trademark of Johnson & Johnson
1 . Holland EJ, Loh J, Bloomenstein M, et al. A comparison associated with TearCare plus LipiFlow systems in reducing dry eyesight disease signs and symptoms associated along with meibomian sweat gland disease. Clin Ophthalmol . 2022; 16: 2861-2871. doi: 10. 2147/OPTH. S368319
2. Gupta PK, Holland EJ, Hovanesian J, et al. TearCare intended for the remedying of meibomian human gland dysfunction inside adult sufferers with dry eye illness: a masked randomized controlled trial. Cornea . 2022; 41(4): 417-426. doi: 10. 1097/ICO. 0000000000002837
About Sight Sciences
Sight Sciences is an eyecare technologies company focused on developing and commercializing innovative solutions intended to transform care and enhance 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 in order to create more effective treatment paradigms that enhance patient treatment 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 particular Company’s TearCare ® System is 510(k) cleared for the application of localized heat therapy in grownup patients along with evaporative dried out eye condition due to meibomian gland dysfunction (MGD), enabling office-based clearance associated with gland obstructions by an eye care professional to address the leading cause of dry eye disease. For more information, visit www.sightsciences.com .
Regarding the TearCare® System
The TearCare System will be FDA removed and pointed out for the application of local heat treatment in adult patients with evaporative dry out eye illness due to meibomian gland dysfunction, when used in conjunction with manual expression of the meibomian glands.
The TearCare System is usually 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 restorative heat” safely and effectively. The portable SmartHub™ communicates directly along with the SmartLids to precisely control the amount of phase transition heating and the duration of treatment. After 15 minutes of healing heat, the Clearance Assistant forceps allows the ECP to control manifestation from the stagnant, obstructed meibum expertly plus precisely by targeting individual meibomian intrigue while obtaining full visual confirmation associated with the achievement of this personalized treatment.
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