Oculis to Present a Late-Breaking Abstract at the 23rd EURETINA Congress on Positive Phase 3 Stage 1 DIAMOND Trial Results for Diabetic Macular Edema
A 12-week Phase 2/3 Double-masked, Randomized, Multicenter Study of OCS-01 OPTIREACH® Technology Topical Dexamethasone Eye Drops in Subjects with Diabetic Macular Edema (DME): Efficacy and Safety Findings
ZUG, Switzerland, and BOSTON, Oct. 05, 2023 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis” or the “Company”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced that the positive readout from Stage 1 of its Phase 3 DIAMOND trial of OCS-01 in patients with diabetic macular edema (DME) will be presented as a late-breaking abstract at the 23rd EURETINA Congress, taking place Thursday, October 5, 2023 through Sunday, October 8, 2023 in Amsterdam, the Netherlands.
23rd EURETINA Congress
| Session: | Landmarks and Late Breakings session |
| Presenter: | Ramin Tadayoni, M.D., Ph.D. |
| Title: | A 12-week Phase 2/3 Double-masked, Randomized, Multicenter Study of OCS-01 OPTIREACH® Technology Topical Dexamethasone Eye Drops in Subjects with Diabetic Macular Edema (DME): Efficacy and Safety Findings |
| Presentation time: | Friday, October 6, 2023, at 12:15 pm CEST |
| Location: | RAI Amsterdam |
OCS-01 is Oculis’ lead product candidate and the first investigational eye drop for both front and back of the eye indications, with positive results in Stage 1 of the Phase 3 DIAMOND trial for diabetic macular edema (DME) announced in May 2023, and positive Phase 3 OPTIMIZE trial results for inflammation and pain following cataract surgery announced in August 2023. Furthermore, the investigator-initiated LEOPARD study evaluating OCS-01 for the treatment of cystoid macular edema (CME) enrolled its first patient in August 2023.
Leveraging Oculis’ proprietary Optireach® technology, OCS-01 is a novel, high concentration (15 mg/ml), topical formulation of dexamethasone. It is developed to reach the retina via an eye drop, a route of administration that is differentiated from currently available therapies, that are all invasive such as ocular implants or intravitreal injections to deliver the medication to the retina. If approved, OCS-01 has the potential to become the first topical preservative-free eye drop for the treatment of DME, the leading cause of vision loss and legal blindness in patients with diabetes.
About Oculis
Oculis (Nasdaq: OCS) is a global biopharmaceutical company purposefully driven to save sight and improve eye care. Oculis’ 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’ 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
Mrs. Sylvia Cheung, CFO
[email protected]
Investor & Media Relations
LifeSci Advisors
Corey Davis, Ph.D.
[email protected]
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 for OCS-01 to become the first topical preservative-free eye drop for the treatment of DME; the potential for OCS-01 to become the first eye drop for both front and back of the eye indications; the potential of OCS-01 for the treatment of DME and inflammation and pain following ocular surgery; the potential of OCS-01 for the treatment of CME; expected future milestones and catalysts; 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 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.
