# Effect of OTX-101 0.09% ciclosporin solution on clinical signs of dry eye disease in patients with moderate-to-severe corneal damage: a post-hoc analysis of randomized clinical trials

## TL;DR

A new eye drop treatment called OTX-101 0.09% ciclosporin improves symptoms and damage in patients with severe dry eye disease.

## Contribution

The study demonstrates the efficacy of OTX-101 in treating dry eye disease with moderate-to-severe corneal damage.

## Key findings

- OTX-101 significantly improved corneal and conjunctival staining compared to a placebo.
- Tear production increased in patients treated with OTX-101.
- Improvements were observed in six clinical parameters after 12 weeks of treatment.

## Abstract

This post-hoc analysis of two OTX-101 clinical trials assessed the efficacy of 0.09% ciclosporin in treating dry eye disease (DED) patients with moderate-to-severe corneal damage.

The criteria for moderate-to-severe corneal damage were defined as a CFS total score (5 zones) of ≥ 6 or single zone ≥ 2 at baseline (modified NEI scale). 516 patients (49% of the intention-to-treat population) met these criteria at baseline. Changes in ocular surface damage (cornea and conjunctiva) and aqueous tear deficiency from baseline were determined through corneal fluorescein staining (CSF), Lissamine green staining (LGS) and Schirmer’s test without anesthesia (ST).

After 12 weeks of treatment with OTX-101 versus (vs.) vehicle, outcomes improved across six parameters: (I) Central CFS mean change from baseline was -0.48 vs. -0.36, p = 0.0144. (II) Total CFS corneal staining change from baseline was -2.30 vs. -1.61 p = 0.0004. (III) Improvement ≥ 50% in total CFS from baseline was 44.8% vs. 33.4% p = 0. 0010. (IV) Conjunctival damage as measured by LGS mean change from baseline was -1.61 vs. -0.99, p = 0.0006. (V) Tear production as measured by ST as percentage of eyes with ≥ 10 mm increase from baseline was 18.2% vs. 8.3% p = 0.0003, and (VI) ST mean change from baseline was +2.94 vs. +0.28 p = 0.0008.

Administration of OTX-101 0.09% leads to statistically significant improvement across six parameters in ocular surface staining and tear production in DED patients with moderate to severe corneal damage.

OTX-101 0.09% CsA is a nanomicellar, aqueous formulation of ciclosporin A, designed to enhance ocular bioavailability and therapeutic efficacy for treating DED. The safety and efficacy of OTX-101 0.09% CsA have been validated in two randomized, double-masked, vehicle-controlled clinical trials.

OTX-101 0.09% CsA is a nanomicellar, aqueous formulation of ciclosporin A, designed to enhance ocular bioavailability and therapeutic efficacy for treating DED. The safety and efficacy of OTX-101 0.09% CsA have been validated in two randomized, double-masked, vehicle-controlled clinical trials.

This post-hoc analysis of pooled data from the two clinical trials focused on patients with moderate-to-severe corneal damage. In this subgroup, treatment with OTX-101 0.09% had a statistically significant benefit over vehicle across three clinical measures: Corneal Fluorescein Staining, Lissamine Green Staining and Schirmer’s Test.

This post-hoc analysis of pooled data from the two clinical trials focused on patients with moderate-to-severe corneal damage. In this subgroup, treatment with OTX-101 0.09% had a statistically significant benefit over vehicle across three clinical measures: Corneal Fluorescein Staining, Lissamine Green Staining and Schirmer’s Test.