Eyeworld

EW FEATURE 54 Products that could change how you practice • September 2018 AT A GLANCE • TrueTear helps dry eye patients by providing neurostimulation. • Ophthalmologists have found that it can be used in a variety of dry eye patients, provided that they still have tear production. • Patients can adjust how often they will use the device to their own needs and to their dry eye severity. • Cost has been a barrier in the ability of TrueTear to reach more patients. by Vanessa Caceres EyeWorld Contributing Writer The concept of neurostimula- tion may be a new one for dry eye, but it's not new in medicine, Dr. Faulkner said. Neurostimulation has been used for decades with chronic pain, post-herpetic neuralgia, com- plex migraines, peripheral vascular disease, obstructive sleep apnea, and other conditions, he said. John Sheppard, MD, president, Virginia Eye Consultants, Norfolk, Virginia, thinks that TrueTear will appeal the most to those who want a natural, homeopathic alternative. At the same time, they can use it synergistically as they continue oth- er dry eye treatments, including arti- ficial tears, punctal plugs, nutrition- als, lid hygiene, thermal pulsation, and prescription medications. Patients who don't want to use drops or who have trouble admin- istering drops—such as those with arthritis in the neck or hands—are potential candidates for TrueTear, Dr. Sheppard said. Patients with post-surgical corneal nerve injury, neurotrophic viral disease, or toxic exposure to preservatives may also lean on TrueTear for help, he added. Stephen Pflugfelder, MD, Baylor College of Medicine, Hous- ton, sees TrueTear as ideal for dry eye patients with episodic pain, particularly office workers who may find their eyes get more irritated as the day goes on. "It also can be for people traveling a lot or going into dry environments. It's good for any aqueous tear patient who has the capability of responding to it," he said. The device is not suited for patients with a cardiac pacemaker, a defibrillator, or another metal device in the head and neck, according to device instructions. 1 It is also con- traindicated in those with chronic nosebleeds or a bleeding disorder. Is it effective? Before it entered the market, True- Tear efficacy was proven with two studies that showed how it in- creased tear production as measured by Schirmer score compared with a control group. 2 Patient tear pro- duction was tracked for up to 180 days. There were only mild adverse events. A randomized, double-masked, placebo-controlled study that Dr. Pflugfelder helped lead found that Dry eye specialists adjust to the addition of TrueTear to their treatment toolbox D ry eye patients can have trouble finding treatments that alleviate their signs and symptoms. TrueTear (Allergan, Dublin, Ireland), which received marketing authori- zation from the U.S. Food and Drug Administration in April of last year, offers a unique option to help this patient group. Ophthalmologists are getting a handle on which patients are best suited for TrueTear, how to explain it, and how often they should use the device. How it works The TrueTear device provides low level neurostimulation via the nose. This sends an afferent signal via the ethmoidal branch of the ophthalmic division of cranial nerve V to the brain, said William Faulkner, MD, director, Scott E. Burk Urgent Eye Clinic, Cincinnati Eye Institute, and voluntary assistant clinical profes- sor, Department of Ophthalmology, University of Cincinnati. An efferent signal via cranial nerve VII results in stimulation of the lacrimal glands. "The result is the production of physiologic tears with the delicate normal balance of lipid, aqueous, and mucous components," he said. This is all done by inserting the device in the nose for up to 3 min- utes at a time. The user can adjust the low level voltage from 1 to 5. Instructions from the manufacturer recommend starting at 2. the device helped to stimulate degranulation of goblet cells in the conjunctiva among 15 subjects. 3 In an unpublished study, Dr. Faulkner found that 71% of 28 patients with moderate to severe dry eye had a favorable impression of TrueTear and rated it 6.92 on a scale of 1 to 10. Among the 28 patients, 25% bought the device immediate- ly; everyone in the study said they would consider purchasing it later. The patients in his study were not satisfied with their current dry eye treatments; 18% of the patients had been diagnosed with Sjögren's syndrome. "Patient acceptance has been generally good for the moderate to severe patients who have tried mul- tiple other treatments and who are interested in a drug-free, drop-free option," Dr. Faulkner said. Dr. Sheppard and colleagues performed a double sham, sin- gle-day masked study of TrueTear neurostimulation compared to nasal prongs alone without current and to current applied extranasally. True- Tear produced significant increases in Schirmer tear secretion, while the two shams showed insignificant tear production changes. "Our study validates the mech- anism of action and highly specific nature of targeted trigeminal nerve stimulation," he said. Frequency of use Instructions for TrueTear show that it can be used up to 10 times a day for up to 30 minutes total. However, it is often used less frequently. "In clinical trials, patients used the device an average of 130 seconds a day over 6 months, av- eraging two to three times a day," Dr. Faulkner said. "Frequency of use diminished over time as symptoms improved." Actual usage tends to vary based on the extent of dry eye that a patient has, said Richard Lewis, MD, Sacramento, California. The device's versatility in terms of usage and voltage is something that Dr. Sheppard views as positive. "It's adaptable and applicable to idio- syncratic needs," Dr. Sheppard said. "The patient controls the duration, frequency, and dose." Insurance, pricing concerns Although TrueTear offers a new potential treatment option, it is cur- rently under a cash-pay model. "The launch has been hampered by poor insurance coverage and high access fees," Dr. Lewis said. "The cash price is quite high, and there are no 'sam- ples' for patients to learn to use and appreciate the device. All of this has made adoption slow." In his small study, Dr. Faulkner found that a number of patients wanted to wait to see if the device would eventually be covered by in- surance; if it is, they would consider using it regularly. Neurostimulation device helps patients produce their own tears Patient using TrueTear Source: William Faulkner, MD continued on page 56

• Blank Page
• Blank Page (1)