Oculis Announces Dosing of First Patient in Randomized Phase 2b (SKYGGN) Clinical Trial of OCS-01 for the Treatment of Inflammation and Pain Following Cataract Surgery
OCS-01 is a proprietary topical nanoparticle formulation of dexamethasone also in a Phase 2b trial for diabetic macular edema (DME)
LAUSANNE, Switzerland, Oct. 07, 2019 (GLOBE NEWSWIRE) - Oculis S.A., a clinical-stage biopharmaceutical company whose mission is to develop novel topical treatments (eye drops) for ophthalmic diseases, today 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.
The company’s leading clinical candidates include, OCS-01 and OCS-02. OCS-01 is currently in clinical trial in patients with DME and post-cataract patients. If approved in DME, OCS-01 has the potential to provide a new non-invasive treatment option for DME patients. OCS-02 is a novel topical anti-TNF alpha antibody in Phase 2 for inflammatory eye diseases and was in-licensed from Novartis.
In addition to its lead clinical candidates, Oculis’ proprietary Solubilizing NanoParticle (SNP) technology platform enables the formulation of drugs as non-invasive topical treatments and enhances their bioavailability in the relevant eye tissues. The Company is leveraging this proprietary technology to generate a pipeline of topical drugs targeting sight-threatening eye diseases.
Oculis has an experienced management team from global ophthalmic companies and is supported by leading international life science investors. Oculis is headquartered in Lausanne, Switzerland, with research operations in Reykjavik, Iceland.
To learn more visit www.oculis.com
Dr. Riad Sherif, CEO
Louie-Anne Gauthier, VP, Strategic Marketing and BD&L