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Multi-center Retrospective Study Demonstrates Statistically Significant Reduction in Signs and Symptoms of Dry Eye Disease
NASHVILLE, Tenn., May 17, 2021 (GLOBE NEWSWIRE) -- ImprimisRx, the nation’s leading ophthalmic-focused outsourcing facility and pharmaceutical compounding business and a wholly owned subsidiary of Harrow Health, Inc. (NASDAQ: HROW), today announced that a study of its Klarity-C Drops® (cyclosporine 0.1% ophthalmic emulsion PF) has been published in the peer-reviewed journal, Clinical Ophthalmology.1 Klarity-C is a compounded cyclosporine eye drop currently prescribed by thousands of doctors across the United States. The preservative-free drop contains an emulsion with chondroitin sulfate and the active ingredient cyclosporine 0.1%, which has long been used to improve tear quality.2-4
“We’re pleased with the outstanding results of this multi-center retrospective study, which illuminate the clinical benefits that twice-daily treatment with our proprietary Klarity-C formulation may offer patients suffering from signs and symptoms of dry eye. More and more U.S. eyecare professionals are recognizing that Klarity-C is an important prescribing choice for the millions of patients suffering with the discomfort and dissatisfaction associated with many other treatment options,” said ImprimisRx President John Saharek. “We developed Klarity-C as an easy-to-use, preservative-free, affordable option that requires no insurance company prior authorizations, manufacturer coupons or rebate forms. We believe this study, performed by three renowned ophthalmologists with extensive dry eye disease pedigrees, supports the positive experiences of the many tens of thousands of patients who have been prescribed Klarity-C.”
Klarity-C is compounded in a 503B FDA-registered and inspected outsourcing facility and is protected by patents issued in the United States and abroad.
Summary of the Study
In this multi-center retrospective study of 50 adult patients (100 eyes), dry eye disease was defined as an ocular surface disease index (OSDI) score over 12 or a corneal staining grade over 1. All patients were treated with Klarity-C. At 3 months, mean OSDI scores improved significantly (38.19 vs 24.18, p < 0.001), as did the mean corneal staining grades (3.62 vs 2.20, p < 0.001). Based on OSDI scores, the number of patients with severe dry eye dropped from 31 to 10, and 17 reached the normal range. Eyes with corneal staining grades of 2 or 3 dropped from 21 to 8; 50 eyes had no corneal staining. No adverse events were observed.
The complete study is now available online.
ImprimisRx is one of the nation’s leading ophthalmic-focused prescription pharmaceutical companies, serving thousands of ophthalmologists and optometrists in all 50 states, with 40 proprietary ophthalmic formulations. For more information about ImprimisRx, including product ordering instructions, please visit imprimisrx.com.
About Harrow Health
Harrow Health, Inc. (NASDAQ: HROW) is an ophthalmic-focused healthcare company. The Company owns ImprimisRx, the nation’s leading ophthalmology outsourcing and pharmaceutical compounding business, and Visionology, a direct-to-consumer eye care subsidiary focused on chronic eye disease. Harrow Health also holds large equity positions in Eton Pharmaceuticals, Surface Ophthalmics and Melt Pharmaceuticals, all of which started as Harrow Health subsidiaries. Harrow Health also owns royalty rights in four clinical stage drug candidates being developed by Surface Ophthalmics and Melt Pharmaceuticals. For more information about Harrow Health, please visit the Investors section of the corporate website, harrowinc.com.
No ImprimisRx compounded formulation is FDA-approved. All ImprimisRx formulations are customizable. Other than drugs compounded at a registered outsourcing facility, all ImprimisRx compounded formulations require a prescription for an individually identified patient consistent with federal and state laws.
1Matossian C, Trattler W, Loh J. Dry Eye Treatment with Topical Cyclosporine 0.1% in Chondroitin Sulfate Ophthalmic Emulsion. Clin Ophthalmol. 2021;15:1979-1984. 2Barber LD, Pflugfelder SC, Tauber J, Foulks GN. Phase III safety evaluation of cyclosporine 0.1% ophthalmic emulsion administered twice daily to dry eye disease patients for up to 3 years. Ophthalmology. 2005;112(10):1790–1794. 3Stevenson D, Tauber J, Reis BL. Efficacy and safety of cyclosporin A ophthalmic emulsion in the treatment of moderate-to-severe dry eye disease: a dose-ranging, randomized trial. The Cyclosporin A Phase 2 Study Group. Ophthalmology. 2000;107(5):967–974. 4Wirta DL, Torkildsen GL, Moreira HR, et al. A Clinical Phase II study to assess efficacy, safety, and tolerability of waterfree cyclosporine formulation for treatment of dry eye disease. Ophthalmology. 2019;126(6):792–800.
For Harrow Health, Inc.:
Jamie Webb, Director of Communications and IR
Holliday Communications, Inc.
Harrow Health, Inc.