- OCS-01 positive results in the first Phase 3 OPTIMIZE-1 trial were presented at the
American Society of Cataract and Refractive Surgery (ASCRS) while topline readout from the second Phase 3 OPTIMIZE-2 is anticipated later this year to support NDA submission - If approved, OCS-01 would be the first once-daily, topical, preservative-free corticosteroid for treating inflammation and pain following ocular surgery
- OCS-01 is also in Phase 3 development as potentially the first eye drop treatment for Diabetic Macular Edema (DME)
Oculis initiated the second Phase 3 OPTIMIZE-2 trial with OCS-01 once daily eye drop in late 2023 and topline readout is expected before the end of 2024. The two Phase 3 OPTIMIZE trials are expected to support an NDA submission.
For more information about ASCRS 2024 visit: https://annualmeeting.ascrs.org/.
About inflammation and pain following ocular surgery
Ophthalmic surgeries are on the rise, mainly due to the aging population and lifestyle changes, and are expected to reach close to 10 million procedures per year in the
About OCS-01 eye drops and the OPTIREACH® technology
Leveraging Oculis’ proprietary OPTIREACH® technology, OCS-01 is a novel, high concentration dexamethasone eye drop. The OPTIREACH® solubilizing formulation technology addresses the main limitations of conventional eye drops by improving the solubility of lipophilic drugs, increasing the residence time on the eye surface and thereby, enabling less frequent administration for front-of-the-eye and the drug passage from the eye surface to the posterior segment for back-of-the-eye diseases.
1 2016 HCUP procedure volume and growth rate, and corroborated by Rochester Epidemiology Project Paper. Third party market research.
2 Meddevicetracker – Ophthalmic Surgical Products Market 2017.
About Oculis
Oculis is a global biopharmaceutical company (Nasdaq: OCS) purposefully driven to save sight and improve eye care. Oculis’ highly differentiated pipeline comprises multiple innovative product candidates in development. It includes OCS-01, a topical eye drop candidate for diabetic macular edema (DME) and for the treatment of inflammation and pain following cataract surgery; OCS-02, a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED) and for non-infectious anterior 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. Headquartered in
For more information, please visit: www.oculis.com
Oculis Contacts
Ms.
sylvia.cheung@oculis.com
Investor & Media Relations
cdavis@lifesciadvisors.com
1-212-915-2577
Cautionary Statement Regarding Forward Looking Statements
This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of OCS-01, including patient impact and market opportunity; the potential of OCS-01 for treating front- and back-of-the-eye diseases; the potential for OCS-01 to become a new standard of care with the first once-daily, topical, preservative-free corticosteroid for treating inflammation and pain following ocular surgery; the potential of OCS-01 for the treatment of DME, inflammation and pain following ocular surgery and CME; expected future milestones and catalysts; expected topline clinical readouts, including the expected topline readout from OPTIMIZE-2; 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; and the timing or likelihood of regulatory filings and approvals, 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
Source:
2024 GlobeNewswire, Inc., source