Oculis’ OCS-01 Eye Drops Studied in LEOPARD Trial to Treat Cystoid Macular Edema

Oculis announced that the first patient has been enrolled in the investigator-initiated LEOPARD trial evaluating the potential of OCS-01 eye drops, Oculis’ high-concentration preservative-free topical Optireach formulation of dexamethasone, for the treatment of cystoid macular edema (CME).

According to the company, the LEOPARD trial is administratively sponsored by the Global Ophthalmic Research Center of Los Altos, California and led by Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology at the Byers Eye Institute, Stanford University School of Medicine, in Palo Alto, California.

The trial aims 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). The prospective, multicenter, open-label, single-armed trial is planned to enroll 24 eligible patients (12 with UME and 12 with PSME). Two different doses will be used. The total treatment period is 24 weeks. The primary endpoints, which will be assessed at 12 weeks, are improvement in central subfield thickness (CST) and visual acuity.

In addition to CME, OCS-01 eye drops are being evaluated to treat diabetic macular edema (DME) as well as inflammation and pain post ocular surgery. Both indications are currently in phase 3 clinical development.

OCS-01 has demonstrated its potential to reduce macular edema as measured by improvements in retinal thickness in a pilot study with uveitic macular edema patients as well as in the recently completed stage 1 of the phase 3 DIAMOND trial in patients with DME, advised Oculis. The company announced the topline results from stage 1 on May 22, 2023.

“I am very excited to investigate the potential of OCS-01 eye drops for the treatment of CME, one of the most common causes of decreased vision in patients following cataract and other ophthalmic surgeries, and in uveitis patients,” commented Professor Nguyen in the company’s press release. “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.”