Oculis Announces Successful End-of-Phase 2 Meeting with the FDA for OCS-01 in Two Ophthalmology Indications
Dr. David P. Bingaman Appointed as Vice President, Global Clinical Development
LAUSANNE, Switzerland, July 27, 2020 (GLOBE NEWSWIRE) -- Oculis S.A., a biopharmaceutical company focused on developing transformative topical (eye drop) ophthalmic treatments using its innovative formulation technologies to improve the sight and lives of patients, today announced that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for OCS-01 in two indications: for the treatment of inflammation and pain following cataract surgery and for the treatment of diabetic macular edema (DME). As a result, the Company is currently planning the Phase 3 trials for both indications, which are expected to begin in the first half of 2021.
“We are very pleased with the guidance received from FDA on key elements of the Phase 3 programs that will support the submission of a New Drug Application (NDA) in both of our targeted indications,” said Riad Sherif, M.D., Chief Executive Officer of Oculis. “We look forward to further demonstrating, in our Phase 3 programs, the potential of OCS-01 as a transformative topical treatment for DME and as potentially the first once a day steroid for the treatment of inflammation and pain following cataract surgery.”
David Bingaman added: “The potential of Oculis’ pipeline candidates is very exciting. I am convinced that if the advanced product candidates, as well as the topical formulation technologies, come to market, they will have a positive impact on the vision and quality of life of millions of people worldwide. Results from two Phase 2 clinical trials reported earlier this year highlighted OCS-01’s ability to provide anti-inflammatory activity following topical ocular dosing in both front- and back-of-the-eye diseases. Not only could OCS-01 be a once-daily steroid for front-of-the-eye inflammation following cataract surgery, it also may be transformational for patients with sight-threatening DME for whom current approved treatments are invasive intra-ocular injections or implants. OCS-02 is another exciting prospect, as it could become the world’s first topical ocular biologic to address other common inflammatory eye conditions, such as uveitis or offer a personalized treatment for severe dry eye patients. Oculis is at a pivotal time in its development and I am very much looking forward to joining the team to advance these innovative candidates towards patients in need.”
Dr. Bingaman joins Oculis from Panoptica where he was Senior Director and Head of Retina Development since 2011, overseeing all development functions and the execution of multiple trials in neovascular age-related macular degeneration (AMD) and diabetic retinopathy using a topical ocular anti-VEGF candidate. Prior to Panoptica, he held several leadership roles with Alcon Research, the former eye-care division of Novartis, moving from Discovery to Development as his teams’ programs were elevated into first-in-man trials.
Oculis S.A. is a biopharmaceutical company focused on developing transformative topical ophthalmic treatments using its innovative formulation technologies to improve the sight and lives of patients.
In addition, Oculis’ formulation discovery focus and capabilities are enabling the development of a pipeline of topical drugs targeting sight-threatening eye diseases that affect both the anterior and posterior segments of the eye.
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