No drops, no plugs: How the iTEAR100 device triggers tears in 30 seconds

Medical technology startup Olympic Ophthalmics has received U.S. Food and Drug Administration (FDA) De Novo clearance for its iTEAR100 Neurostimulator, a first-in-class external neurostimulation device designed to temporarily increase acute tear production. The clearance, announced on May 15, 2020, positions the iTEAR100 as a novel non-pharmaceutical solution for adults suffering from dry eye symptoms, offering an alternative to traditional treatments like eye drops or punctal plugs.

The iTEAR100, a pocket-sized handheld device, works by delivering a targeted neuromodulation stimulus to the external nasal region, activating the trigeminal nerve and downstream parasympathetic pathways responsible for tear production. This controlled stimulation can reportedly trigger natural tear secretion in under 30 seconds.

With FDA backing and clinical validation, Olympic Ophthalmics is preparing to commercialize the device and tap into a large underserved patient population impacted by dry eye disease—an area where pharmaceutical compliance and chronic symptom management have long been a challenge.

What is the iTEAR100 Neurostimulator and how does it work to relieve dry eye symptoms?

The iTEAR100 Neurostimulator is a non-invasive, drug-free wearable that stimulates the external nasal branch of the trigeminal nerve when gently pressed to the skin just beside the nose. The neurostimulation process activates a natural neural reflex arc, stimulating tear gland function through parasympathetic nervous system pathways.

According to data published by Olympic Ophthalmics, the device was designed for ease of use, with patients initiating tear production by simply pressing an ‘on’ button while holding the device to their skin. The stimulation lasts less than 30 seconds per use and can be repeated twice daily.

Dr. Cynthia Matossian, founder and Medical Director of Matossian Eye Associates and a principal investigator in the iTEAR100 clinical trials, stated that the device is both intuitive and fast-acting. She noted that patients in the study experienced tear production within seconds of using the device, offering a highly accessible alternative to conventional treatments.

What clinical data supported the FDA’s De Novo clearance for Olympic Ophthalmics?

The FDA granted De Novo marketing authorization for the iTEAR100 Neurostimulator based on results from two multicenter studies: a double-masked, randomized, sham-controlled clinical trial and a separate single-arm study involving daily use. In both trials, participants used the device twice a day, and outcomes were measured based on standardized Schirmer’s testing to quantify tear volume.

The controlled trial confirmed statistically significant increases in tear production in the treatment group compared to the sham group, establishing both the efficacy and tolerability of the external neurostimulation mechanism.

Safety outcomes from both studies showed the device was well-tolerated with minimal adverse events, making it a viable candidate for at-home use. Patients did not report significant discomfort or adverse systemic effects, bolstering the case for neuromodulation as a new frontier in ophthalmic device therapy.

Why does this FDA clearance matter in the context of the dry eye disease treatment market?

Dry eye disease is a chronic, multifactorial condition that affects more than 16 million adults in the United States alone, with millions more suffering from episodic symptoms due to aging, digital screen usage, environmental exposure, or autoimmune conditions. Traditional pharmacological approaches, such as cyclosporine eye drops (e.g., Restasis) or lifitegrast (e.g., Xiidra), have met with varying success but face challenges including patient non-compliance, side effects like stinging or blurred vision, and cost.

Olympic Ophthalmics’ iTEAR100 represents a departure from pharmaceutical interventions by directly targeting the neurological pathway responsible for tear secretion. If adopted widely, it could reduce patient dependence on topical medications, expand accessibility for those with contraindications to standard therapies, and provide relief in cases where inflammation is not the primary driver of symptoms.

Dr. Michael Gertner, Founder and Chief Executive Officer of Olympic Ophthalmics, stated that the FDA clearance marks not just a major corporate milestone but also the start of a new class of neurostimulation-based devices in eye care. He described the company as a team of specialists across ophthalmology, neuromodulation, and medical device commercialization, all focused on reducing the cost of care and increasing therapeutic options for ocular diseases.

How does Olympic Ophthalmics position itself in the broader neurotechnology and ophthalmology landscape?

Founded with the ambition of merging neuromodulation science with practical ophthalmic needs, Olympic Ophthalmics is among a growing cohort of startups targeting functional disorders through nerve stimulation. The firm’s interdisciplinary team spans neuroengineers, ophthalmologists, and venture investors, with an emphasis on developing low-risk, patient-controlled interventions.

The iTEAR100 joins a limited number of FDA-cleared neurostimulation devices in ophthalmology. Its compact design, lack of consumables, and non-invasiveness could make it an attractive alternative in both clinical and home-care settings.

The device enters a market that has traditionally been fragmented across over-the-counter artificial tears, prescription medications, and invasive procedures like punctal plugs or thermal pulsation therapy. With minimal maintenance and the possibility of being prescribed by general ophthalmologists and optometrists, the iTEAR100 could see adoption among first-line care providers seeking a low-risk, fast-acting intervention.

Is the dry eye device market ready for neuromodulation solutions?

Investor and industry sentiment around neuromodulation for non-neurological conditions has been steadily growing. While most neuromodulation products have historically targeted pain, epilepsy, or depression, the application of external stimulation for functional ophthalmology opens up new therapeutic categories.

Analysts covering the ophthalmic devices sector in 2020 note that technologies with home-use approval and favorable safety profiles are well positioned for patient-led care models—especially in chronic conditions where frequent clinical visits and long-term drug use are impractical.

The FDA’s De Novo pathway designation indicates that the agency views the iTEAR100 as a novel but low-to-moderate risk device class, allowing Olympic Ophthalmics to establish a new regulatory category without the burden of comparison to predicate devices. This strategic advantage could pave the way for expanded indications or next-gen variants of the iTEAR platform in the future.

What are the key takeaways from FDA clearance of iTEAR100 for dry eye patients and the eye care industry?

• Olympic Ophthalmics has secured FDA De Novo clearance for its iTEAR100 Neurostimulator, enabling it to market the device as a non-drug solution for acute dry eye relief.

• The iTEAR100 is a handheld, external neurostimulation device that activates tear production by stimulating the trigeminal nerve externally through the nasal region.

• Clinical trials demonstrated statistically significant increases in tear production with minimal side effects.

• The device introduces a new class of treatment options for dry eye disease, which affects over 16 million adults in the U.S. alone.

• Olympic Ophthalmics is positioning itself at the intersection of neuromodulation and ophthalmology, targeting a high-burden, under-served patient segment.