Oculis announced that it has successfully completed an end-of-phase 2 meeting with the 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,” Riad Sherif, MD, Chief Executive Officer of Oculis, said in a company news release. “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.”
Oculis also announced the appointment of David P. Bingaman, DVM, PhD, D. ACVO, as Vice President, Global Clinical Development to further strengthen the company’s development capabilities. Dr. Bingaman brings more than 20 years of pharmaceutical experience in discovery research and clinical development in the ophthalmology area.
In this new position at Oculis, he will play a key leadership role in all clinical development programs to advance the company’s pipeline of novel therapeutic candidates, including OCS-01 and OCS-02. A priority for Dr. Bingaman and Oculis in the coming months will be the planning and implementation of the phase 3 trials. The design of the phase 3 programs in both indications will be based on the positive phase 2 trials with OCS-01 in each indication reported earlier in 2020 and feedback recently received from the FDA at end-of-phase 2 meeting and scientific advice from the European Medicines Agency.
“I am delighted to welcome David to the Oculis team,” commented Dr. Sherif. “David brings therapeutic expertise as well as in-depth clinical development experience that will be very valuable to the company as we advance our novel topical anti-inflammatory treatments OCS-01 and OCS-02 through late-stage clinical development. David will be based in the U.S., where we are currently establishing our operations.”
“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,” Mr. Bingaman said.
“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 intraocular injections or implants,” he said “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.