Leading Peer-Reviewed Ophthalmic Journal Publishes Study on ImprimisRx’s Proprietary Klarity-C® Drops

Rhea-AI Summary

Harrow Health, Inc. (NASDAQ: HROW) announced a multi-center retrospective study demonstrating significant improvements in patients with dry eye disease using its Klarity-C Drops® (cyclosporine 0.1%). Published in Clinical Ophthalmology, the study involved 50 patients and showed a marked decrease in ocular surface disease index (OSDI) scores and corneal staining grades after three months of treatment. The study highlighted no adverse events and emphasized Klarity-C's advantages over existing treatments, including its affordability and lack of insurance hurdles.

Positive

• Significant improvement in OSDI scores from 38.19 to 24.18 (p < 0.001) after treatment.
• Reduction in severe dry eye cases from 31 to 10 patients.
• Klarity-C showed no adverse events during the study.
• Harrow Health's proprietary formulation is gaining wider acceptance among eye care professionals.

Negative

• None.

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.

About ImprimisRx
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.

Contacts:
For ImprimisRx:		For Harrow Health, Inc.:
Deb Holliday		Jamie Webb, Director of Communications and IR
Holliday Communications, Inc.		Harrow Health, Inc.
deb@hollidaycommuications.net		jwebb@harrowinc.com
412-877-4519		615-733-4737

FAQ

What were the results of the recent study on Harrow Health's Klarity-C Drops?

The study showed significant improvements in OSDI scores and corneal staining grades for patients treated with Klarity-C, indicating effective relief from dry eye symptoms.

How many patients were involved in the study of Klarity-C Drops?

The study involved 50 adult patients.

What is the significance of the p-value reported in the Klarity-C study?

The p-values (p < 0.001) indicate that the results from the treatment with Klarity-C Drops are statistically significant.

What is Klarity-C Drops and how is it used?

Klarity-C Drops is a compounded ophthalmic solution containing cyclosporine 0.1%, prescribed to improve tear quality in patients suffering from dry eye disease.

Does Klarity-C Drops have any side effects?

No adverse events were reported in the study, indicating a favorable safety profile.