The trial is a prospective, multi-center, open label, single-armed trial which plans on enrolling 24 eligible subjects with cystoid macular edema.
Oculis has announced enrollment of the first patient in the LEOPARD trial evaluating OSC-01 eye drops for the treatment of cystoid macular edema (CME).
OSC-01 is a novel, high concentration preservative-free topical OPTIREACH formulation of dexamethasone, according to a press release from the company.1
The LEOPARD trial is administratively sponsored by the Global Ophthalmic Research Center and is led by Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology at the Byers Eye Institute, Stanford University School of Medicine.
Oculis states that the goal of the LEOPARD trial is to “evaluate the efficacy and safety profile of OCS-01 eye drops in the management of two different forms of CME: Uveitic Macular Edema (UME) and Post-Surgical Macular Edema (PSME).”1
The trial is a prospective, multi-center, open label, single-armed trial which plans on enrolling 24 eligible subjects, 12 with UME and 12 with PSME, according to the company. Two different doses will be used over the treatment period of 24 weeks. Primary endpoints will be assessed at 12 weeks and are improvement in central subfield thickness (CST) and visual acuity.1
OSC-01 eye drops are also being explored in treatment of diabetic macular edema (DME) as well as CME. Oculis recently released positive top-line results from the Phase 3, DIAMOND trial of OSC-01 for DME.
“I am very excited to investigate the potential of OCS-01 eye drops for the treatment of cystoid macular edema, one of the most common causes of decreased vision in patients following cataract and other ophthalmic surgeries, and in uveitis patients,” said Nguyen. “Given the recently announced DIAMOND Phase 3 Stage 1 data readout in DME, which showed statistically significant reduction in retinal thickness with OCS-01, we believe in its potential to provide a paradigm shift in the treatment of post-surgical and uveitic macular edema, in addition to DME.”
CME may occur as a complication of ocular conditions, including uveitis and ocular surgery, and is a leading cause of vision loss worldwide, according to a press release from Oculis. Additionally, 28% of patients who undergo ocular surgery, including patients with diabetes, uveitis and other risk factors, have a higher risk of developing CME following the procedure.2