Oculis announces positive results from phase 3 OPTIMIZE trial
Oculis has announced positive topline results from its phase 3 OPTIMIZE trial for its OCS-01 eyedrops, a once daily, high concentration, preservative free, topical Optireach formulation of dexamethasone to treat inflammation and pain following ocular surgery.
The trial took place across 25 sites in the US and included 241 patients who were randomised to receive either the eyedrops or vehicle for 14 days following cataract surgery. The drug met both primary efficacy endpoints: absence of inflammation a day 15 and absence of pain at day 4, both with statistical significance.
Eric Donnenfeld, MD, co-chair of Oculis’ scientific advisory board, commented: “The results of the phase 3 OPTIMIZE trial are exciting because once daily OCS-01 showed to be superior and highly potent in reducing inflammation and pain compared to vehicle with a favorable safety profile. This is significant for patients who have undergone cataract surgery, as they currently need to self-administer multiple daily doses of eye drops to alleviate inflammation and pain. The availability of a preservative-free treatment that requires only a once-daily eye drop could greatly benefit a large number of patients who undergo ocular surgeries worldwide.”
Riad Sherif, MD, Oculis’ CEO, added: “I am very pleased with the positive readout of OPTIMIZE. A once daily topical steroid eye drop has shown solid results in reduction of inflammation and pain and offers the potential of a truly simplified dosing regimen. We are on track to advance OCS-01 for inflammation and pain following ocular surgery towards an NDA submission with FDA. We now have positive phase 3 topline results with OCS-01 preservative-free eye drops in treating front-of-the-eye inflammation and pain following ocular surgery, as well as stage 1 phase 3 results for back-of-the-eye diabetic macular edema (DME) from the DIAMOND program, opening for the first time ever new opportunities for topical eye drops to address highly unmet patient needs in both front- and back-of-the-eye indications.”
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