- Following significant strides made in advancing its late-stage pipeline with dual positive readouts in 2023 and a few more anticipated this year, Oculis further expands its executive leadership team with the appointment of industry veteran as President of Research & Development
- Dr. Shah’s joins Oculis from Iveric Bio with extensive experience in drug development, regulatory affairs and ophthalmology, with over a dozen successful market approvals, which will be key as Oculis initiates preparations for global marketing applications including its first NDA submission to the U.S. FDA
ZUG, Switzerland and BOSTON, April 10, 2024 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced the appointment of Dr. Snehal Shah, executive leader with over two decades of research & development (R&D) and regulatory experience, to the role of President of R&D. In this new role, Dr. Shah will be responsible for leading research and development strategies, and working towards achieving market authorizations by directing global regulatory activities required for future New Drug Application (NDA) submissions to the U.S. Food and Drug Administration (FDA), and the equivalent for regulators in other territories.
Dr. Shah joins Oculis from Iveric Bio where he served as Chief Regulatory & Product Strategy Officer and led the successful approval of Izervay® for Geographic Atrophy in the U.S. He brings over 20 years of global experience in regulatory science, research & development, pharmacovigilance, and product strategy gained at leading large, medium and biotech pharmaceutical companies including Hoffmann La-Roche / Genentech, Noven Pharmaceuticals (Member of the Hisamitsu Group), Kyowa Kirin and Iveric Bio. He has a proven track record of spearheading innovative programs in various therapeutic areas including in ophthalmology for both small molecules and biologics through product development lifecycle phases from conception through commercialization.
Riad Sherif, M.D., Chief Executive Officer of Oculis: “We are thrilled to welcome Snehal to Oculis as we continue to expand our U.S. footprint. Snehal’s leadership and development expertise, especially in ophthalmology, will be pivotal to advancing our innovative and differentiated pipeline. His extensive strategic experience in leading R&D and regulatory functions, and successful track record of bringing over a dozen market applications to approval will play a pivotal role in our efforts to deliver transformative new therapies to patients suffering from eye diseases.”
Snehal Shah, Pharm.D., President of R&D of Oculis: “I am thrilled to join the exceptionally talented team at Oculis to lead R&D activities during a period of significant momentum and expansion which comes as we advance our leading candidate OCS-01 through Phase 3 trials towards our first anticipated NDA submission and expect the OCS-02 RELIEF Phase 2b trial results this quarter. Oculis’ highly diversified pipeline provides an opportunity to be part of an endeavour that aims to shift the treatment paradigm for ocular disorders, supporting patients throughout their disease continuum, which can lead to vision loss and ultimately blindness.”
About Oculis
Oculis (Nasdaq: OCS) is a global biopharmaceutical company purposefully driven to save sight and improve eye care. Oculis’s highly differentiated clinical-stage pipeline comprises multiple innovative product candidates in development for eye diseases of high unmet need. It includes OCS-01 eye drops, a topical candidate in Phase 3 development for diabetic macular edema (DME) and inflammation and pain following ocular surgery; OCS-02 eye drops, a topical biologic candidate in Phase 2 development for dry eye disease (DED) and uveitis; and OCS-05, a disease modifying candidate for acute optic neuritis (AON) and other neuro-ophthalmic disorders, such as glaucoma, diabetic retinopathy, geographic atrophy, and neurotrophic keratitis. The first in-patient, proof-of-concept trial with OCS-05 is currently ongoing in France. Headquartered in Switzerland and with operations in the US, Oculis’s goal is to deliver life-changing eye treatments to patients worldwide. The company is led by an experienced management team with a successful track record in the pharmaceutical industry, supported by leading international healthcare investors.
For more information, please visit: www.oculis.com
Oculis Contacts
Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com
Investor & Media Relations
LifeSci Advisors
Corey Davis, Ph.D.
cdavis@lifesciadvisors.com
1-212-915-2577
Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements and information. For example, the potential of Oculis to deliver transformative new therapies to patients suffering from eye diseases; expected future milestones and catalysts; anticipated clinical readouts, including the expected OCS-02 RELIEF Phase 2b trial results; the potential benefits of Oculis’ executive leadership team additions; the initiation, timing, progress and results of Oculis’ clinical and preclinical studies; Oculis’ research and development programs, regulatory and business strategy, future development plans, and management; Oculis’ ability to advance product candidates into, and successfully complete, clinical trials; the timing or likelihood of regulatory filings and approvals; and the timing or likelihood of Oculis’ NDA submissions to the U.S. FDA and the equivalent for regulators in other territories, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the U.S. Securities and Exchange Commission (the “SEC”). Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.