Ophthalmic medical device company Sight Sciences today announced the launch of a new pivotal trial exploring the safety and effectiveness of its TearCare system in patients with dry eye disease.
The Menlo Park, Calif.-based company’s TearCare system is a wearable therapeutic eyelid technology designed to deliver energy over a specified period to liquify meibum, an oily coating on the eye’s surface which prevents tear film evaporation.
The device allows the patient to blink and for the eye to remain comfortably open during the procedure, Sight Sciences said.
“We need additional treatment options for dry eye. I like several aspects of the TearCare System’s iLid device. It is non-invasive and conforms to the patient’s lid anatomy thereby individualizing and optimizing treatment and allows the patient to blink freely throughout the procedure,” Dr. Edward Holland of the Cincinnati Eye Institute said in a prepared statement.
The randomized, controlled, 200-patient Olympia trial aims to explore the safety and effectiveness of the system in treating signs and symptoms of dry eye disease compared to a daily regimen of warm compress therapy and lid massage, the company said.
“I am excited to participate in the Olympia trial and offer a customized, non-invasive treatment option to my patients. Unlike other dry eye technologies, the TearCare System is a smart and wearable solution that automatically regulates and maintains sufficiently elevated therapeutic temperatures for a sufficient period of time to effectively melt meibum. I can further customize the procedure by using the TearCare specialized instrument to manually, fully clear the meibomian glands of melted meibum,” Dr. Paul Karpecki of Lexington, Ky.’s Kentucky Eye Institute said in prepared remarks.
The trial’s primary endpoint is tear breakup time at one month, and several other endpoints are slated to be evaluated to assess changes in dry eye signs and symptoms. Patients will be followed out to six months, after which patients will be re-treated and followed for another six months.
The study follows a pilot study which showed a significant increase in tear breakup time, reduction in corneal and conjunctival staining and improvement in patient symptoms following treatment, Sight Sciences said.
“Over the past several months, we have worked diligently to select investigational sites for successful completion of the trial. I look forward to working directly with the OLYMPIA sites and completing a trial that will provide a long-term impact in the dry eye space,” clinical and regulatory affairs VP Anne-Marie Ripley said in a prepared release.
“The initiation of this study is a significant milestone for Sight Sciences and our cutting-edge TearCare technology. I am truly proud of our team that has worked obsessively in stealth over the past five years to iterate to a final product design we think will set a new bar for dry eye therapy. Our pivotal trial brings us one step closer to our vision of delivering a first-class dry eye treatment experience for both patients and eye care professionals,” prez & CEO Paul Badawi said in a press release.
Last October, Sight Sciences said it closed a $10 million oversubscribed Series C round to support expanding manufacturing and its US commercial team and the launch of its devices into the dry eye and microinvasive surgery markets.