Swiss biopharmaceutical company Oculis has enrolled the first patient in its investigator-initiated LEOPARD trial of OCS-01 eye drops to treat cystoid macular oedema (CME).
The open-label, multi-centre study aims to assess the efficacy and safety of two different doses of OCS-01 eye drops in treating two different forms of CME, namely Uveitic Macular Oedema (UME) and Post-Surgical Macular Oedema (PSME).
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It is due to enrol 12 patients with UME and the same number of individuals with PSME, who will each receive treatment for 24 weeks.
The trial’s primary endpoints include improvement in central subfield thickness (CST) and visual acuity, which will be evaluated after 12 weeks.
It will be sponsored by the Global Ophthalmic Research Center in California and led by Quan Dong Nguyen, a member of Oculis’ scientific advisory board.
Oculis CEO Riad Sherif said: “Oculis is proud to support this investigator-initiated trial led by Professor Nguyen in cystoid macular edema with OCS-01 eye drops, to explore its potential in this vision-threatening eye condition.
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By GlobalData“OCS-01 is Oculis’ lead compound currently being investigated in two Phase III clinical trials in DME, as well as inflammation and pain following ocular surgery, with promising efficacy and safety data.”
Earlier this year, Oculis reported that data from the first stage of the Phase III DIAMOND trial of OCS-01 had met its primary efficacy endpoint of mean change in best corrected visual acuity (BCVA) from baseline at week six.
The data from Stage I of the DIAMOND trial and a pilot study of OCS-01 also showed improvements in retinal thickness in DME patients and UME patients respectively.
OCS-01 eye drops are a high-concentration, preservative-free, topical OPTIREACH formulation of dexamethasone.
Other product candidates in Oculis’ portfolio include OCS-02 for dry eye disease and OCS-05 for acute optic neuritis.
