Oculis Holding AG has enrolled the first patient in its investigator-initiated Efficacy and Safety of Dexamethasone ophthaLmic Suspension Eye drOps in Uveitic and Post Surgical mAculaR eDema (LEOPARD) trial assessing the use of OCS-01 eye drops to treat cystoid macular edema (CME).
Give me a rundown on OCS-01.
OCS-01 is a novel, high-concentration, once-daily (QD), and preservative-free topical drug candidate of dexamethasone currently in clinical trials for treating:
- Inflammation and pain post-ocular surgery
- Diabetic macular edema (DME) (NCT05066997)
- CME
To note, Oculis reported positive topline data for the phase 3 DIAMOND trial on OCS-01 for DME back in May 2023. Read about that here.
How does it work?
The eye drop employs Oculis’ OPTIREACH solubilizing nanoparticle technology, which is a proprietary platform designed to enable the formulation of drugs as non-invasive topical treatments.
The result: potentially extending their residence time on the ocular surface and enhancing bioavailability in relevant ocular tissues.
How has it performed in previous trials?
In May 2023, the company reported positive topline data from the phase 3 DIAMOND trial (NCT05066997), where its primary objective was to determine an optimal dosing regimen for treating DME. See our coverage here.
And more recently, the company released positive topline data from the phase 3 LEOPARD trial (for post-op pain/inflammation). Click here for the details.
Now talk about this trial.
The LEOPARD phase 3 trial (NCT05066997) is a prospective, multi-center, double-masked, randomized, controlled study enrolling an estimated 24 patients (ages 18+):
- 12 patients with uveitic macular edema (UME)
- 12 with post-surgical macular edema (PSME)
Conducted across the 5 sites over the course of 24 weeks, the investigator-initiated trial will include four phases:
- Screening
- Loading
- Treatment
- Follow-up
What’s the dosing schedule?
Patients will randomly be assigned to four separate groups to receive one of two different doses of OCS-01:
- High dose UME → 6 drops OCS-01 per day
- Low dose UME → 3 drops OCS-01, 3 drops placebo group (both per day)
- High dose PSME → 6 drops OCS-01 per day
- Low dose PSME → 3 drops OCS-01, 3 drops placebo (both per day)
Now break these 24 weeks down.
Per Clinical Trials, participants will receive their assigned treatments until Week 4, after which they will then be randomized into groups and continue the assigned treatments until Week 12.
At Week 12, if edema is still present (indicated via optical coherence tomography [OCT]), patients will receive treatment per the study’s retreatment criteria.
What’s being measured?
Primary outcome measures include the mean change, at Week 12, in:
- Central subfield thickness (CST) compared to baseline (measured via OCT)
- Early treatment of diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA) letter score
Secondary and other outcomes (including potential adverse effects) can be found here.
Any input from the experts yet?
While the trial is being administratively sponsored by the Global Ophthalmic Research Center (Los Altos, California), Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology at the Byers Eye Institute, Stanford University School of Medicine, will serve as lead investigator.
“We believe in (OCS-01’s) potential to provide a paradigm shift in the treatment of post-surgical and uveitic macular edema, in addition to DME,” he stated in a news release.
When can we expect data?
According to ClinicalTrials, the study is slated for completion by April 2024. Stay tuned for interim data in the meantime!