Sight Sciences Announces TearCare® Clinical Data Published in Cornea

Rhea-AI Summary

Sight Sciences (Nasdaq: SGHT) announced promising results from the OLYMPIA trial published in Cornea, aiming to expand the FDA indication for its TearCare^® System. This system targets evaporative dry eye disease (DED) caused by meibomian gland dysfunction (MGD), responsible for 86% of DED cases. The trial, enrolling 135 adults, demonstrated non-inferiority of TearCare compared to LipiFlow, showing significant improvements in DED symptoms without serious adverse events. Sight Sciences aims to shift treatment paradigms from drops to device-based interventions.

Positive

• The OLYMPIA trial achieved its primary endpoints, demonstrating the non-inferiority of TearCare to LipiFlow.
• TearCare showed significant improvements in all assessed signs and symptoms of DED.
• No serious adverse events were reported during the trial, indicating a favorable safety profile.
• Publication in a high-impact journal enhances credibility and visibility of TearCare.

Negative

• None.

Clinical trial data being used to seek expanded indication from the FDA

MENLO PARK, Calif., Oct. 20, 2021 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT), a growth-stage medical device company focused on addressing the underlying causes of the world's most prevalent eye diseases, today announced publication in the journal Cornea of positive results from OLYMPIA, a multicenter, investigator-masked, randomized controlled trial.

The TearCare^® System is presently indicated for the application of localized heat when the current medical community recommends the application of a warm compress to the eyelids. Sight Sciences is currently seeking an expanded indication from the FDA for the application of localized heat therapy in adult patients with evaporative dry eye disease (DED) due to meibomian gland dysfunction (MGD), when used in conjunction with manual expression of the meibomian glands.

MGD is the primary underlying cause of evaporative DED, the most common type of DED. It is estimated that MGD underscores 86% of DED cases in clinic and population-based studies. Since MGD is associated with thickened or hardened oils in eyelid glands causing a deficient tear lipid layer and accelerated tear evaporation (“evaporative dry eye”), we believe that medical devices and procedures designed to apply controlled, therapeutic levels of heat to soften or liquify thickened meibum and alleviate eyelid gland obstructions are truly differentiated from eye drops for dry eye.

“I am very proud to be a part of this randomized trial, which was designed to evaluate the clinical effects of using eyelid-worn medical device technologies on key MGD-related signs and symptoms of DED,” said Preeya K. Gupta, MD, Managing Director of Triangle Eye Consultants and first author of the study. “Historically, the most common treatments for dry eye include artificial tears and prescription eye drops. Yet over time and as further validated by this study, we have come to realize the extreme importance of treating underlying meibomian gland obstruction.”

The OLYMPIA study enrolled a total of 135 adult subjects assigned to either a TearCare (n=67) or LipiFlow (n=68) treatment arm, each consisting of a single treatment. The study was designed to show the non-inferiority of TearCare to LipiFlow, measured by the mean change from baseline to one month in primary effectiveness endpoints, including Tear Break-Up Time (TBUT) and Total Meibomian Gland Secretion Score (MGSS). Secondary effectiveness endpoints included the mean change from baseline to one month in Ocular Surface Disease Index (OSDI) score, corneal and conjunctival staining scores, Symptom Assessment in Dry Eye (SANDE) score, and Eye Dryness Score. The primary safety endpoint was the incidence of ocular adverse events. The secondary safety endpoints included discomfort/pain during and after the procedures, change in Best Corrected Visual Acuity (BCVA), and change in intraocular pressure (IOP).

The non-inferiority primary endpoints for TearCare were met in the study. Use of both TearCare and LipiFlow was associated with improvements in all assessed signs and symptoms of DED measured in the study. No subject in either group experienced any serious adverse events or device-related adverse events.

“Clinical results from the OLYMPIA study are extremely encouraging because they support the efficacy of treating MGD with a physician-directed intervention,” said Dr. Gupta. “The goal is to melt and clear hardened, obstructive meibum to allow the meibomian glands to resume the production of healthy, liquid meibum that can then coat the aqueous and mucin components of the tear with every blink and prevent premature tear evaporation.”

“We are extremely proud that a peer-reviewed journal in eyecare with a high impact factor like Cornea determined that the data from our OLYMPIA RCT were technically, scientifically and clinically compelling,” said Paul Badawi, Co-Founder and CEO of Sight Sciences. “Our mission at Sight Sciences is to transform eyecare by developing and delivering clinically differentiated solutions that allow eyecare providers to comprehensively and consistently address the root underlying causes of eye disease. It is extremely gratifying to our entire team, as well as our OLYMPIA clinical partners, both ophthalmologists and optometrists, that such an important step in our missionary work to develop products and product candidates for use in procedures that can transform the treatment paradigm in dry eye from eyedrops to procedural interventions was recognized by the leading journal in ocular surface disease.”

About Sight Sciences
Founded in 2011, Sight Sciences develops and commercializes intelligently designed and engineered products that target the underlying causes of the world’s most prevalent eye diseases. The company currently markets two products, the OMNI^® Surgical System and the TearCare^® System. For more information, visit www.sightsciences.com.

About the TearCare^® System
The TearCare^® System is currently indicated for the application of localized heat when the current medical community recommends the application of a warm compress to the eyelids. Such applications would include Meibomian Gland Dysfunction (MGD), Dry Eye, or Blepharitis.

TearCare^® is a registered trademark of Sight Sciences.
© 2021 Sight Sciences. All rights reserved.

Forward-Looking Statements

This press release, together with other statements and information publicly disseminated by the Company, contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and includes this statement for purposes of complying with these safe harbor provisions. Any statements made in this press release or during the earnings call that are not statements of historical fact, including statements about our beliefs and expectations, are forward-looking statements and should be evaluated as such. Forward-looking statements include information concerning possible or assumed future results of operations, including descriptions of our business plan and strategies. These statements often include words such as “anticipate,” “expect,” “suggests,” “plan,” “believe,” “intend,” “estimates,” “targets,” “projects,” “should,” “could,” “would,” “may,” “will,” “forecast” and other similar expressions. We base these forward-looking statements on our current expectations, plans and assumptions that we have made in light of our experience in the industry, as well as our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances at such time. Although we believe that these forward-looking statements are based on reasonable assumptions at the time they are made, you should be aware that many factors could affect our business, results of operations and financial condition and could cause actual results to differ materially from those expressed in the forward-looking statements. These statements are not guarantees of future performance or results. The forward-looking statements are subject to and involve risks, uncertainties and assumptions, and you should not place undue reliance on these forward-looking statements. These forward-looking statements include, but are not limited to, statements concerning the following: estimates of our total addressable market, future revenue, expenses, capital requirements, and our needs for additional financing; our ability to enter into and compete in new markets; the impact of the COVID-19 pandemic on our business, our customers’ and suppliers’ businesses and the general economy; our ability to compete effectively with existing competitors and new market entrants; our ability to scale our infrastructure; our ability to manage and grow our business by expanding our sales to existing customers or introducing our products to new customers; our ability to establish and maintain intellectual property protection for our products or avoid claims of infringement; potential effects of extensive government regulation; our ability to obtain and maintain sufficient reimbursement for our products; our abilities to protect and scale our intellectual property portfolio; our ability to hire and retain key personnel; our ability to obtain financing in future offerings; the volatility of the trading price of our common stock; our expectation regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act (the “JOBS Act”); our ability to maintain proper and effective internal controls; and the other important factors discussed under the caption “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, as may be updated from time to time in subsequent filings. These cautionary statements should not be construed by you to be exhaustive and are made only as of the date of this press release. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. 

Media contact:
Shay Smith
Health+Commerce
707.971.9779
shay@healthandcommerce.com

Investor contact:
Philip Taylor
Gilmartin Group
415.937.5406
Investor.Relations@Sightsciences.com

FAQ

What is the purpose of the OLYMPIA trial conducted by Sight Sciences?

The OLYMPIA trial aims to evaluate the effectiveness of the TearCare system in treating evaporative dry eye disease caused by meibomian gland dysfunction.

What were the results of the OLYMPIA trial for TearCare?

The trial showed that TearCare met its non-inferiority primary endpoints compared to LipiFlow, with significant improvements in dry eye symptoms.

What is meibomian gland dysfunction and its relevance to dry eye disease?

Meibomian gland dysfunction is the primary cause of evaporative dry eye disease, affecting 86% of DED cases by disrupting the lipid layer of tears.

What are the next steps for Sight Sciences after the OLYMPIA trial results?

Sight Sciences plans to seek an expanded FDA indication for the TearCare system based on the positive trial results.

How does TearCare differ from traditional treatments for dry eye?

TearCare provides a procedural intervention to treat the root cause of dry eye, while traditional treatments typically involve artificial tears and eye drops.