Innovations focusing on improved patient experience

Company poised to conduct additional trials, develop pipeline of technology. Patient experience is a major factor in these MIGS and dry eye innovations. 

With a goal of becoming an innovator in minimally invasive glaucoma surgery (MIGS) and procedure-based dry eye treatments, Sight Sciences earlier this year completed a $56 million round of growth capital funding, which will be used to accelerate the growth of the company’s OMNI surgical system and its TearCare system in the United States.

The funding also will help develop a global commercial infrastructure to conduct additional clinical trials and to develop a pipeline of innovations. Sight Sciences was founded by two brothers-Paul Badawi, who had a background in investing in medical device companies, and David Badawi, MD, an ophthalmologist. 

In 2006, while attending the American Society of Cataract and Refractive Surgery annual meeting, they decided they could do some good for patients by innovating devices to treat the underlying disease state of prevalent diseases.

They settled on glaucoma and dry eye as areas of focus, recognizing the unmet need in those diseases, and began to develop ideas. In 2011, the brothers incorporated Sight Sciences, and began to raise funds to develop products and bring them to market.

Soon after, the commercial infrastructure was created, and the company moved toward a strong commercial focus. The company’s overall goal is “treating the underlying disease state with innovative products that surgeons and eyecare providers want to use, therefore bringing these innovations to more patients,” said Shawn O’Neil, chief commercial officer.

The company’s focus in this area is evident through OMNI’s ability to target the three potential points of resistance in the conventional outflow pathway (Schlemm’s canal, the distal collector channels, and the trabecular meshwork) with a single, disposable device, whereas TearCare’s approach allows for eyecare professionals to deliver targeted heat to the meibomian glands with a personalized, open-eye experience, allowing the patients to keep their eyes open and blink during the procedure, he noted.

Brandon Baartman, MD, ophthalmologist at Vance Thompson Vision in Omaha, NE, uses both OMNI and TearCare, and said the two products offer some unique advantages.

“In the glaucoma space, OMNI is an easy-to-use, dual-purpose device that offers our patients an implant-free optimization of their natural outflow pathway,” he said.

A major feature of the OMNI system is that it can perform both viscodilation and trabeculotomy.

“Not only can you stretch the collector channels and Schlemm’s canal with viscodilation, you can also unroof the trabecular meshwork,” Dr. Baartman said. “And having both of those abilities in one tool really allows you to apply that tool to more surgical scenarios.”

Dr. Baartman explained that the labeling for certain procedures that OMNI is used for is not tied to a specific stage of glaucoma. “There is more room for us as surgeons to utilize the technology in the best interest of the patient,” he added.

Dr. Baartman pointed out there are a number of tools and devices available for the treatment of meibomian gland dysfunction (MGD) and said there are unique ways he is able to use the system that differentiates it from other products.

Dr. Baartman, who treats a lot of patients who have both glaucoma and ocular surface disease, said the TearCare system is easy to use in these patients, as it does not require the cumbersome manipulation called for by some of the other devices in this space. He also said the system is uniquely comfortable for the patient. 

Another advantage is that the system allows a physician more face-to-face time with the patient because the procedure is physician-directed, he noted. As one final advantage in clinical practice, Dr. Baartman said he utilizes the system at one of his slit lamp cameras.

“I can actually videotape, or take photos of, the oil secretions as I am expressing them from the lids,” he said, adding that he can then review the images with the patients to help them better understand their condition and show the patients that their efforts are paying off, as positive reinforcement.

The OMNI Surgical System performs two procedures- the catheterization and transluminal viscodilation of Schlemm’s canal (up to 360º), and the cutting of trabecular meshwork. The system enables access to Schlemm’s canal with a microcatheter through a single clear corneal incision, and is engineered with an internal reservoir that delivers a controlled amount of viscoelastic fluid.

The dual mechanisms of action are designed to allow the system to address the entire natural trabeculocanalicular outflow pathway to reduce intraocular pressure in adult patients with open-angle glaucoma. The procedures can be done in conjunction with cataract surgery using the same corneal incision or as a stand-alone procedure.

The TearCare system is indicated for the application of localized heat for meibomian gland dysfunction (MGD), dry eye disease, or blepharitis, where the current standard recommendation is application of a warm compress to the eyelids The personalized open-eye experience provides targeted and adjustable thermal energy to the meibomian glands by heating the lids via proprietary SmartLid technology.

This, along with the patients’ own blinking during the heating process, facilitates natural meibum expression. A rechargeable software-driven Smart Hub communicates with the SmartLids, which allows for the tailoring of the delivery and consistency of warming to the eyelid devices, which conform to the patient’s eyelids.

The TearCare technology also allows for the eyecare provider to precisely target individual glands depending on the patient’s need by manually clearing the warmed meibum. In the procedure, patients actively contribute to their procedure success by blinking during the heating process and physicians are able to target precisely the glands that need the most effort to give the patients the best chance at an optimal outcome.

Ongoing trials 
The OMNI system is currently in a clinical trial that will evaluate the impact of ab-interno transluminal viscoelastic delivery and trabeculotomy using the platform, in conjunction with cataract surgery, on IOP and the use of hypotensive medications in mild to moderate open-angle glaucoma.

The OLYMPIA study compares the TearCare system with the LipiFlow thermal pulsation system with regard to safety and efficacy in relieving the patients’ signs and symptoms of dry eye disease.