Olympic Ophthalmics Announces FDA Clearance and Availability of Its Next-Generation iTEAR100 Neurostimulation Device
Olympic Ophthalmics announced that the FDA has granted 510(K) clearence for its second-generation iTEAR100 device, a prescription neuromodulation therapy to acutely increase tear production in adult patients over a 30-day period.
The second-generation device is a connected device offering telehealth tools, including prescription download capability and activation through a mobile phone app. These tools further strengthen its place as a bridge between the ophthalmic clinic and the patient as the only at-home prescription medical device cleared by the FDA to increase natural tear production.
With its connected features, improved device longevity and easily controllable treatment, iTEAR100 now offers an unparalleled value in eye care. Ongoing innovations to the platform will layer in additional diagnostic capabilities and disease management features for a complete telehealth solution to extend ophthalmic practices into the home environment and empower patients.
The company also announced three ongoing trials to support its broad label "increasing tear production in adult patients" and its convenient and easy-to-start-up treatment paradigm. These trials include 1) patients with newly diagnosed dry eye disease with iTEAR100 as the first treatment; 2) a virtual telehealth trial where iTEAR100 is prescribed, monitored, and titrated by a physician without the patient having to visit a doctor office; and 3) a label expansion study to optimize basal tear secretion versus reflex tearing to take advantage of its unique on-off and customizable treatment tiers iTEAR100 offers.
Additionally, 12 patents have been issued or allowed, including nine in the United States and one each in the European Union, Japan, and China, covering all aspects of the device mechanism and treatment methods.
"The technology of neurostimulation, already implemented broadly in other fields of medicine, is ideal for ophthalmic applications and, specifically, the ocular surface. All three layers of the tear film are positively affected. This new mode of neurostimulation has been well received by my patients and treats all types of dry eye disease," Paul Karpecki, OD, Clinical Director, Corneal Services and Advanced Ocular Surface Disease at Kentucky Eye Institute, said in a company news release.
"Home strategies for addressing dry eye are just as important as in-office strategies. With the addition of the elegant-and-simple, easy-to-learn-and-use external neurostimulation device iTEAR100, we have seen patients attain improvements in baseline tear production, tear film stability, corneal staining and meibomian gland function, as well as symptoms—real-world data in my clinic that match data published in Translational Vision Science and Technology (TVST 9(12) article 23, 2020)," said Laura M. Periman, MD, founder and Director of Dry Eye Services and Clinical Research at the Periman Eye Institute in Seattle.
"After several months of slowed development due to supply chain constraints, we are ready to roll out the iTEAR100 with its associated features at scale which will facilitate its usage in a telehealth environment. We are also excited to finish enrollment of our three phase 4 trials which will further support our current label for iTEAR100," said Michael Gertner, MD, founder and CEO of Olympic Ophthalmics.
"We are also pleased that the uniqueness of the iTEAR100 technology and treatment paradigms are being recognized by patent offices across the world. Neurostimulation approaches to Ocular Surface Disease have received FDA approvals and have also earned clinical acceptance by patients and clinicians,” he added.
About iTEAR100
iTEAR100 is the only prescription medical device for home use that can increase natural tear production in all adult patients. It is non-chemical, and does not touch the eye. Olympic Ophthalmics is a start-up company in the Seattle area financed by leading institutional investor Biostar Capital.
