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A Phase 3, randomized, double-masked study of OTX-101 ophthalmic solution 0.09% in the treatment of dry eye disease. Ophthalmology. 2019;126(9):1230-37. 4. Drugs for common eye disorders. Med Lett Drugs Ther. 2019;1586. 5. Hessen M. Cyclosporine Shoot-out: How Do They Match Up? Rev Optom. 2019 May 15;156(5):58-65. 42-9. 6. Lee H, Chung B, Kim KS, et al. Effects of topical loteprednol etabonate on tear cytokines and clinical outcomes in moderate and severe meibomian gland dysfunction: randomized clinical trial. Am J Ophthalmol. 2014 Dec;158(6):1172-1183.e1. 7. Karakus S, Agrawal D, Hindman HB, et al. Effects of Prolonged Reading on Dry Eye. Ophthalmology. 2018 Oct;125(10):1500-05. 8. Moore QL, De Paiva CS, Pflugfelder SC. Effects of Dry Eye Therapies on Environmentally Induced Ocular Surface Disease. Am J Ophthalmol. 2015 Jul;160(1):135-42.e1. 9. Yin J, Kheirkhah A, Dohlman T, et al. Reduced efficacy of low-dose topical steroids in dry eye disease associated with graft-versus-host disease. Ophthalmology. June 2018;190:17- 23. 10. White DE. Annual anti-inflammatory review. Ocular Surgery News. 2020 Feb 25. 11. Stevenson W, Chauhan SK, Dana R. Dry eye disease: an immune-mediated ocular surface disorder. Arch Ophthalmol. 2012 Jan;130(1):90-100. 12. Saldahna IJ, Petris R, Han G, et al. Research Questions and Outcomes Prioritized by Patients With Dry Eye. JAMA Ophthalmol. 2018;136(10):1170-1179. SECTION II: ANTERIOR SEGMENT CARE NEW DED DRUG STUDY CONFIRMS OUR RATIONALE • A 0.25% loteprednol etabonate suspension is being evaluated for use in dry eye. • Studies show that “results indicate that LE 0.25% suspension is a rapid-acting, safe and effective anti-inflammatory therapy.”1 • The study used the loteprednol QID for two weeks, and (unsurprisingly) none of the hundreds of patients experienced an IOP increase greater than 5mm Hg.1 • We have been making these general statements for over 20 years with regard to loteprednol! 1. Guttman Krader C. Investigational topical corticosteroid demonstrates efficacy for dry eye, Oph Times, April 15, 2020 SIGNS vs. SYMPTOMS: WHICH MATTERS TO PATIENTS? Key findings from a survey of 420 patients in 15 countries: • “The three most important questions pertained to effectiveness of patient education, environmental modifications and topical anti-inflammatory eye drops.” • Patient interest in “education was top ranked by all subgroups.” • The three most important outcomes were ocular burning and stinging, ocular discomfort, and ocular pain.” • There was little interest in “signs” as patient-centric outcomes (symptoms) were deemed most relevant to patients. —JAMA Ophthalmol, October 2018 (see ref. 12) DRY EYE DISEASE: IT’S ALL ABOUT THE SYMPTOMS • “The most important metric when treating DED is patient symptoms.” (Our take: We have been stressing this in our collective lectures for over a decade.) • “Your patient is not really interested in corneal clearance or the slope of tear osmolarity decline.