Oculis’ product candidate enters Phase2b clinical trial

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09.10.2019
Eye

Oculis mission is to develop novel topical treatments (eye drops) for ophthalmic diseases. The company announced the dosing of the first patient in a Phase 2b clinical trial evaluating the efficacy and safety of OCS-01 for the treatment of inflammation and pain following cataract surgery.

OCS-01 is a unique topical formulation of dexamethasone based on the Company’s proprietary Solubilizing NanoParticle (SNP) technology platform and has the potential to become the first once daily topical steroid to treat inflammation and pain following ocular surgery.

The prospective, multi-center, randomized Phase 2b clinical trial will evaluate the efficacy and safety of OCS-01 in the management of pain and inflammation following cataract surgery. The study is being conducted in 20 specialized ocular surgery centers in the U.S.

“Our SNP platform enables us to formulate topical therapeutics for delivery to both the back- and front-of-the eye,” said Riad Sherif, M.D., Chief Executive Officer of Oculis. “This study initiates the clinical evaluation of OCS-01 in a second indication, which is its first for the front-of-the eye. Our lead program is in a Phase 2b trial of OCS-01 in patients with DME. That study has completed enrollment and we anticipate presenting the study results early in 2020. We look forward to updating you on both of these trials.”

Oculis is a clinical-stage biopharmaceutical company whose mission is to develop novel topical treatments (eye drops) for ophthalmic diseases for both back- and front-of-the-eye in order to improve the sight and lives of patients worldwide. These topical treatments represent an unprecedented technical advance for patients with back-of-the-eye diseases that are currently managed only by intra-ocular injections or implants; while topical treatments for front-of-the-eye disease are designed to improve patient outcomes by increasing drug bioavailability, reducing dosing frequency and improving patient compliance.

(Press release)

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