A Phase II, prospective, multi-center, single masked, randomized, controlled, study to determine the efficacy and safety of dexamethasone ophthaLmic suspension Eye drOps in uveitic and Post-surgicAl maculaR eDema: The LEOPARD Study

Abstract

Purpose : Cystoid macular edema (CME) is a leading cause of central vision loss in developed countries. The physiological and anatomical barriers of the eye, create a challenge for topical drugs to treat posterior segment pathology. OCS-01 is a novel and innovative high-concentration eye drop formulation of dexamethasone, designed to enhance drug penetration to the back of the eye. The LEOPARD Study aims to evaluate the efficacy and safety of OCS-01, in the management of uveitic macular edema (UME) and post-surgical macular edema (PSME).

Methods : LEOPARD is a Phase II, multi center, single masked, randomized, controlled trial. 24 subjects (12 UME, 12 PSME) with new or recurrent CME < 1 year, intraretinal and/or subretinal fluid, and central subfield thickness (CST) ≥ 320 µm by SD-OCT at baseline, are to be enrolled across at least 5 sites. All subjects receive 1 drop of OCS-01 6 times a day (every 4 hours) for 4 weeks. At week 4, both UME and PSME subjects are randomized into a High-dose group or Low-dose group. High-dose group continues to receive 6 drops of OCS-01 per day and the Low dose group receives 3 drops of OCS-01 and 3 drops of Placebo. Subjects receive assigned treatments until week 12 at which primary endpoint assessments of changes in BCVA and CST are performed. Starting week 12, if CME persists on OCT, subjects are retreated based on the retreatment criteria.

Results : 8 subjects are enrolled; 4 UME and 4 PSME. 3 have reached the primary end point. No drug-related AEs have been reported.

Conclusions : OCS-01 up to 6 drops daily has been well tolerated by subjects with CME who have received OCS-01 treatment. The ongoing study will examine the efficacy and safety of OCS-01.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.