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In the practice of optometry, there are many innovations in develop-ment that have the potential to enable eye care providers to deliver care to patients with dry eye more

effectively while also improving prac-tice efficiency. This article takes a look at some of these advances.

TELEMEDICINE IN DRY EYEAlthough it is not new, telemedi-

cine 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 degenera-tion, 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 prac-tice, dry eye disease (DED) and tele-medicine have been a great fit thus far. Here are some ways I’ve recently used telemedicine to enhance patients’ outcomes and experience with DED.

Patient EducationWe 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 mem-ber or me. The discussion can include self-pay in-office procedures such as intense pulsed light therapy and treat-ment for meibomian gland disease.

Progress ChecksWe 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 addi-tional opportunity to discuss the chronic and progressive nature of the disease, encourage compliance with prescribed therapies, identify any challenges with obtaining the recom-mended products, and refine treat-ment goals and management strate-gies. An in-office follow-up is typically scheduled after this virtual visit at an appropriate time interval.

Prescribing From AfarWe 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 treat-ment 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 pre-dict that a hybrid approach of peri-odic 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 treat-ment 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 main-taining the standard of care.

INNOVATIONS IN DRY EYE TREATMENT

What’s coming and what’s on the horizon. BY DAMON DIERKER, OD, FAAO

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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 com-

ponent in the pathogenesis of dry eye.1 Cyclosporine ophthalmic emulsion 0.05% (Restasis, Allergan) and lifitegrast ophthalmic solution 5% (Xiidra, Novartis) are FDA-approved antiinflam-matory 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 corti-costeroid that was engineered with the goal of maintaining robust antiinflam-matory 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 eta-bonate ophthalmic suspension 0.25% (KPI-121, Kala Pharmaceuticals) for the treatment of DED.5 The company plans to commercialize this prod-uct under the brand name Eyesuvis. Compared with placebo, KPI-121, utilizing Kala’s Ampplify mucus-pen-etrating particle technology, demon-strated a statistically significant reduc-tion 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 corticoste-roid with labeling for DED flares.

NEXT-GENERATION NEUROSTIMULATION Intranasal Tear Neurostimulator

The lacrimal functional unit (LFU) consists of the lacrimal gland,

goblet cells, and meibomian glands.6 Coordination of the LFU helps main-tain a healthy ocular surface. The parasympathetic nervous system con-trols tear film homeostasis partially via the trigeminal nerve.7 Activation of this pathway can activate all com-ponents of the LFU.8

TrueTear (Allergan) is a handheld intranasal tear neurostimulation device indicated to provide a tem-porary 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 NeurostimulatorThe iTEAR100 (Olympic

Ophthalmics) is an external tear neuro-stimulation 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 trigemi-nal parasympathetic pathway to stimu-late 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

Nasal SprayIn the recently completed phase 3

ONSET-2 study, the use of vareni-cline (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 rang-ing from mild to severe.

OC-01 is a highly selective nicotinic acetylcholine agonist preservative-free

Figure. Demodex mite in a microscope view.

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COVER FOCUS MASTER THE MANAGEMENT OF OCULAR SURFACE DISEASE

nasal spray that also activates the trigeminal parasympathetic pathway. A pharmacologic neurostimulation treatment option with a broad indica-tion would be a welcome addition for both primary and adjunctive treat-ment of DED patients.

A BREAKTHROUGH IN MANAGING DEMODEX?

Demodex mites (Figure) are a com-mon 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 specifi-cally 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 num-ber of our patients with DED. n

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 kera-toconjunctivitis 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 retrometa-bolically 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 EYESUVIS 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-pharmaceu-ticals-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.

DAMON DIERKER, OD, FAAOn Director, Optometric Services, Eye Surgeons of

Indiana, Indianapolisn Member, Modern Optometry Editorial Advisory Boardn damon.dierker@esi-in.com; Twitter @damondierkern Financial disclosure: Consultant (Allergan, Notal

Vision, Novartis, Oyster Point Pharma)