Efficacy of a Novel Water-Free Topical Cyclosporine 0.1 % Solution for Optimizing the Ocular Surface in Patients with Dry Eye and Cataract

Esen K Akpek; John D Sheppard; Adam Hamm; Simone Angstmann-Mehr; Sonja Krösser

doi:10.1097/j.jcrs.0000000000001423

Efficacy of a Novel Water-Free Topical Cyclosporine 0.1 % Solution for Optimizing the Ocular Surface in Patients with Dry Eye and Cataract

J Cataract Refract Surg. 2024 Feb 9. doi: 10.1097/j.jcrs.0000000000001423. Online ahead of print.

Authors

Esen K Akpek¹, John D Sheppard², Adam Hamm³, Simone Angstmann-Mehr⁴, Sonja Krösser⁴

Affiliations

¹ The Wilmer Eye Institute, The Johns Hopkins University, Baltimore, MD, USA.
² Virginia Eye Consultants, Norfolk, VA, USA.
³ Statistics & Data Corporation, Tempe, AZ, USA.
⁴ Novaliq GmbH, Heidelberg, Germany.

PMID: 38334413
DOI: 10.1097/j.jcrs.0000000000001423

Abstract

This is a pooled analysis from two phase III clinical trials investigating a water-free topical cyclosporine 0.1% for the treatment of moderate to severe dry eye. The analyses included 1162 patients: 35% with cataract, 20% with pseudophakia and 45% without cataract. Demographics or baseline characteristics were comparable across groups except for age and vision. The cyclosporine treated patients achieved large mean improvements from baseline by day 15: -3.7 in patients without cataract, -3.2 in patients with cataract and -3.1 in pseudophakic patients. These improvements were statistically significantly higher compared to the respective vehicle groups. In the cataract subgroup, 59% of patients treated with cyclosporine achieved ≥3 grade improvements in corneal staining score, as early as day 15. The magnitude of the effect and early onset of action make this novel cyclosporine solution a promising candidate for pre-operative management of ocular surface in patients undergoing cataract surgery.