llergan’s TrueTear Intranasal Tear Neurostimulator was granted marketing authorization by the FDA in April.
A novel dry eye (DE) therapy may do away with patient drug regimens and invasive therapies.
In research presented at the the 121st Annual Meeting of the American Academy of Ophthalmology (AAO 2017) in New Orleans, LA, a nasal neurostimulator device was used to safely produce more tears — and therefore, more relief — for DE patients.
The handheld device, Allergan’s TrueTear™ Intranasal Tear Neurostimulator, was granted marketing authorization by the US Food and Drug Administration (FDA) in April. It was initially designed by Michael Ackermann, a biomedical engineer with Stanford Biodesign.
Ackermann found a large, unmet need for optimal DE treatments while researching medical gaps in eye clinics. The neurostimulator uses a chemical compound to stimulate patient eye glands to release complete tears, comprised of the same elements of a natural tear.
Researchers from the Cincinnati Eye Institute, in data presented at AAO 2017, tested the device’s safety and efficacy.
In 97 patients with moderate-to-severe DE, TrueTear’s ability to produce eye-moisturizing tears was tested for 180 days following administration. In tests to determine tear production, researchers noted “significantly higher” tear levels after the device’s nasal stimulation.
The DE patients also reported easy use with the device, and no adverse events were reported.
Edward J. Holland, MD, lead researcher, Director of Cornea Services at Cincinnati Eye Institute, and Professor of Clinical Ophthalmology at the University of Cincinnati, said he believes TrueTear will be a “very beneficial treatment option for our dry eye patients.”
“It’s an innovative technology that effectively and safely increases tear production,” Holland said.
The study backed 2 previous clinical trials, in which tear production was noted in 145 DE adult patients, according to Allergan.
John Sheppard, MD, MMSC, a Professor of Ophthalmology at Eastern Virginia Medical School, and President of Virginia Eye Consultants, noted that neurostimulation has been a therapy method for various disorders in the last 30 years.
“TrueTear is the first of its kind to provide a temporary increase in tear production in this way," Sheppard said.
DE is considered one the most common conditions seen by eye care practitioners. It is reported in about 1 of every 4 patients, and has been diagnosed in more than 20 million US patients.
The drug-free alternative to lubricating eye drops and artificial tears may be the first of its kind, but could eventually be among more devices reliant on tear stimulation.
A press release regarding TrueTear's previous trials was made available.
This article was originally published by MD Magazine.