In the practice of optometry, there are many innovations in development that have the potential to enable eye care providers to deliver care to patients with dry eye more effectively while also improving practice efficiency. This article takes a look at some of these advances.
TELEMEDICINE IN DRY EYE
Although it is not new, telemedicine has definitely seen an increase in use and popularity in recent months. Prior to COVID-19, I admit, I was naïve as to the power of telemedicine in optometry. I was an early adopter of the ForeseeHome AMD Monitoring Program (Notal Vision), and I continue to advocate for its use for patients with high risk age-related macular degeneration, but more robust telemedicine and remote monitoring services were lacking in my practice.
Our ability to use technology to provide more efficient patient care is accelerating at a rapid rate. Patients enjoy the flexibility of receiving care without an in-office visit. In my practice, dry eye disease (DED) and telemedicine have been a great fit thus far. Here are some ways I’ve recently used telemedicine to enhance patients’ outcomes and experience with DED.
We can educate patients about DED and available treatment options before their first visit to our office via a video chat or phone call from a staff member or me. The discussion can include self-pay in-office procedures such as intense pulsed light therapy and treatment for meibomian gland disease.
We can offer a virtual progress check, in lieu of an in-office visit, 2 to 4 weeks after initiating DED therapy, which may range from nutraceuticals to prescription therapy to in-office procedures. This gives us an additional opportunity to discuss the chronic and progressive nature of the disease, encourage compliance with prescribed therapies, identify any challenges with obtaining the recommended products, and refine treatment goals and management strategies. An in-office follow-up is typically scheduled after this virtual visit at an appropriate time interval.
Prescribing From Afar
We can provide selected DED therapies (eg, nutraceuticals, artificial tears, lid hygiene products, and even prescription therapy in some cases) via virtual consult, then schedule an in-office follow-up visit a few weeks later to refine the diagnosis and treatment plan. There are many effective options that can be safely prescribed via telemedicine because they have few, if any, contraindications.
We are only scratching the surface with the power of telemedicine to help manage patients with DED. I predict that a hybrid approach of periodic in-office visits mixed with virtual follow-ups will be well accepted by patients and will have the potential to lead to similar or improved treatment outcomes. Direct-to-consumer DED marketing campaigns from pharmaceutical companies will bring awareness of DED front and center to our patients—both established and new. We can take advantage of this by creating flexible, versatile protocols to manage these patients while maintaining the standard of care.
Next, let’s look at some therapies that may be available soon that may affect how we will treat patients with DED in the future.
TOPICAL STEROIDS ON LABEL FOR DED?
Chronic inflammation is a key component in the pathogenesis of dry eye.1 Cyclosporine ophthalmic emulsion 0.05% (Restasis, Allergan) and lifitegrast ophthalmic solution 5% (Xiidra, Novartis) are FDA-approved antiinflammatory therapies for DED. In addition, topical corticosteroids can elicit potent antiinflammatory effects, and they are often used for induction therapy2 and management of acute DED flares.3 Specifically, loteprednol etabonate 0.5% (Lotemax, Bausch + Lomb) is a corticosteroid that was engineered with the goal of maintaining robust antiinflammatory activity while minimizing risk of side effects,4 including elevated IOP and cataract formation. However, available formulations of loteprednol etabonate are not specifically indicated for the treatment of DED.
Positive results were recently announced for the phase 3 Short Term Relief in Dry Eye (STRIDE 3) trial, which evaluated loteprednol etabonate ophthalmic suspension 0.25% (KPI-121, Kala Pharmaceuticals) for the treatment of DED.5 The company plans to commercialize this product under the brand name Eysuvis. Compared with placebo, KPI-121, utilizing Kala’s Ampplify mucus-penetrating particle technology, demonstrated a statistically significant reduction in ocular discomfort severity from baseline to day 15. Patients with more severe symptoms (a predefined subgroup) also showed significant improvement in ocular discomfort severity. If it is approved, KPI-121 could be the first topical corticosteroid with labeling for DED flares.
Intranasal Tear Neurostimulator
The lacrimal functional unit (LFU) consists of the lacrimal gland, goblet cells, and meibomian glands.6 Coordination of the LFU helps maintain a healthy ocular surface. The parasympathetic nervous system controls tear film homeostasis partially via the trigeminal nerve.7 Activation of this pathway can activate all components of the LFU.8
TrueTear (Allergan) is a handheld intranasal tear neurostimulation device indicated to provide a temporary increase in tear production in adults with severe dry eye symptoms.9 In my clinical experience, I have found this novel technology to be effective in selected cases. Unfortunately, this product was recently discontinued.
Extranasal Tear Neurostimulator
The iTEAR100 (Olympic Ophthalmics) is an external tear neurostimulation device recently approved by the FDA that applies a small amount of mechanical stimulation to the skin on the outside of the nose to stimulate the external nasal nerve in a few seconds. This activates the trigeminal parasympathetic pathway to stimulate natural tear production. A recently completed 6-month study showed an immediate post-stimulation increase in tear production and an unstimulated increase in basal tear production. There was a corresponding improvement in symptoms, corneal staining, and meibum quality.10
In the recently completed phase 3 ONSET-2 study, the use of varenicline (OC-01, Oyster Point Pharma) nasal spray was shown to improve both signs and symptoms of DED.11 A greater percentage of study patients had improved Schirmer score and eye dryness score when treated with either 0.6 mg/mL or 1.2 mg/mL doses of OC-01 compared with placebo. Of note, the study population consisted of patients with DED symptoms ranging from mild to severe.
OC-01 is a highly selective nicotinic acetylcholine agonist preservative-free nasal spray that also activates the trigeminal parasympathetic pathway. A pharmacologic neurostimulation treatment option with a broad indication would be a welcome addition for both primary and adjunctive treatment of DED patients.
A BREAKTHROUGH IN MANAGING DEMODEX?
Demodex mites (Figure) are a common cause of blepharitis, implicated in approximately 45% of chronic cases.12 The clinical finding of cylindrical dandruff is pathognomonic. In one study, 100% of lashes with cylindrical dandruff were found to have Demodex mites.13 Standard treatments include lid hygiene products containing tea tree oil and oral ivermectin.14 A new topical formulation that causes paralysis and death of Demodex mites (TP-03, Tarsus Pharmaceuticals) is under investigation. Phase 2 studies have shown that a 6-week course of twice daily dosing of TP-03 cured 70% to 80% of patients.15
A phase 2b/3 trial is under way.16 If approved, TP-03 would likely be the first prescription agent specifically indicated for the treatment of Demodex blepharitis.
THE FUTURE OF DRY EYE MANAGEMENT
When I think about the future of managing patients with dry eye, I envision a hybrid model of patient visits, with both in-office evaluations and virtual follow-ups. This care model, along with the addition of new therapeutic options, will hopefully allow us to provide more efficient and effective treatment for a greater number of our patients with DED.
- 1. Stevenson W, Chauhan SK, Dana R. Dry eye disease: an immune-mediated ocular surface disorder. Arch Ophthalmol. 2012;130(1):90-100.
- 2. Sheppard JD, Donnenfeld, ED, Holland EJ, et al. Effect of loteprednol etabonate 0.5% on initiation of dry eye treatment with topical cyclosporine 0.05%. Eye Contact Lens. 2014;40(5):289-296.
- 3. Marsh P, Pflugfelder SC. Topical nonpreserved methylprednisolone therapy of keratoconjunctivitis sicca in Sjögren syndrome. Ophthalmology. 1999;106(4):811-816.
- 4. Comstock TL, Sheppard JD. Loteprednol etabonate for inflammatory conditions of the anterior segment of the eye: twenty years of clinical experience with a retrometabolically designed corticosteroid. Expert Opin Pharmacother. 2018;19(4):337-353.
- 5. Kala Pharmaceuticals announces statistically significant results for primary and key secondary endpoints in STRIDE 3 clinical trial evaluating EYSUVIS for signs and symptoms of dry eye disease [press release]. Kala Pharmaceuticals. March 9, 2020. https://investors.kalarx.com/news-releases/news-release-details/kala-pharmaceuticals-announces-statistically-significant-results. Accessed June 21, 2020.
- 6. Stern ME, Gao J, Siemasko KF, et al. The role of the lacrimal functional unit in the pathophysiology of dry eye. Exp Eye Res. 2004;78(3):409-416.
- 7. Kossler AL, Wang J, Feuer W, Tse DT. Neurostimulation of the lacrimal nerve for enhanced tear production. Ophthalmic Plast Reconstr Surg. 2015;31(2):145-151.
- 8. Brinton M, Kossler AL, Patel ZM, et al. Enhanced tearing by electrical stimulation of the anterior ethmoid nerve. Invest Ophthalmol Vis Sci. 2017;58(4):2341-2348.
- 9. TrueTear Intranasal Tear Neurostimulator Professional Information Guide. Allergan. https://allergan-web-cdn-prod.azureedge.net/actavis/actavis/media/allergan-pdf-documents/labeling/ifu_truetear_professional.pdf. Accessed June 21, 2020.
- 10. Olympic Ophthalmics presents clinical evidence for iTEAR100 [press release]. PR Newswire. May 22, 2020. www.prnewswire.com/news-releases/olympic-ophthalmics-presents-clinical-evidence-for-itear100-301064095.html. Accessed July 8, 2020.
- 11. Oyster Point Pharma announces positive results in ONSET-2 phase 3 trial of OC-01 nasal spray for the treatment of the signs and symptoms of dry eye disease [press release]. Oyster Point Pharma. https://investors.oysterpointrx.com/news-releases/news-release-details/oyster-point-pharma-announces-positive-results-onset-2-phase-3. Accessed June 21, 2020.
- 12. Zhao Ya-E, Wu LP, Hu L, Xu JR. Association of blepharitis with Demodex: a meta-analysis. Ophthalmic Epidemiol. 2012;19(2):95-102.
- 13. Gao YY, Di Pascuale MA, Li W, et al. High prevalence of Demodex in eyelashes with cylindrical dandruff. Invest Ophthalmol Vis Sci. 2005;46(9):3089-3094.
- 14. Jones L, Downie LE, Korb D, et al. TFOS DEWS II management and therapy report. Ocul Surf. 2017;15(3):575-628.
- 15. Data presented at Ocular Innovation Summit (OIS) at SECO. March 4, 2020.
- 16. Tarsus Pharmaceuticals raises $60 million in series B financing [press release]. Tarsus Pharmaceuticals. January 8, 2020. www.prnewswire.com/news-releases/tarsus-pharmaceuticals-raises-60-million-in-series-b-financing-300983254.html. Accessed June 21, 2020.