TNF alpha inhibitor (Arthrogen)

ZUG, Switzerland and BOSTON, May 24, 2023 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, announces that its Head of Development, Dr. Bastian Dehmel, will be participating in the 2023 EuDES (European Dry Eye Society) Meeting in Munich, Germany on June 2-3, 2023, where he will be presenting in the session “Future developments in Dry Eye” among other innovative companies and experts in Dry Eye Disease. Date / Time: Saturday June 3, 2023, from 3pm – 4pm CETSession: Future developments in Dry EyePresentation Title: The clinical efficacy and safety of topical TNF alpha inhibitor (OCS-02) in Dry Eye DiseaseChairpersons: Prof. Christophe Baudouin, M.D., FARVO (co-director), Professor of Ophthalmology and Chairman of Ophthalmology III in Quinze-vingts National Ophthalmology Hospital, ParisProf. Elisabeth Messmer, M.D., F.E.B.O., Professor of Ophthalmology at Ludwig-Maximilians-University (LMU) Munich 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, Europe, and China, 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 Contacts Investor Relations LifeSci AdvisorsCorey Davis, Ph.D.cdavis@lifesciadvisors.com1-212-915-2577 Media Relations Consilium Strategic CommunicationsAmber Fennell, Tracy Cheung, David Daley oculis@consilium-comms.com Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements and information. For example, statements regarding 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’ proxy statement and the prospectus for Oculis’ offering, 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.

EMA’s human medicines committee ( CHMP ) has endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee ( PRAC ) to minimise the risk of serious side effects with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders. These side effects include cardiovascular conditions, blood clots, cancer and serious infections. These medicines should be used in the following patients only if no suitable treatment alternatives are available: those aged 65 years or above, those at increased risk of major cardiovascular problems (such as heart attack or stroke), those who smoke or have done so for a long time in the past and those at increased risk of cancer. JAK inhibitors should be used with caution in patients with risk factors for blood clots in the lungs and in deep veins (venous thromboembolism, VTE) other than those listed above. Further, the doses should be reduced in patient groups who are at risk of VTE, cancer or major cardiovascular problems, where possible. The recommendations follow a review of available data, including the final results from a clinical trial 1 of the JAK inhibitor Xeljanz (tofacitinib) and preliminary findings from an observational study involving Olumiant. The review also included advice from an expert group of rheumatologists, dermatologists, gastroenterologists and patient representatives. The review confirmed Xeljanz increases the risk of major cardiovascular problems, cancer, VTE, serious infections and death due to any cause when compared with medicines belonging to the class of TNF-alpha inhibitors. EMA has now concluded that these safety findings apply to all approved uses of JAK inhibitors in chronic inflammatory disorders(rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, ulcerative colitis, atopic dermatitis and alopecia areata). The product information for JAK inhibitors used to treat chronic inflammatory disorders will be updated with the new recommendations and warnings. In addition, the educational material for patients and healthcare professionals will be revised accordingly. Information for patients Janus kinase (JAK) inhibitors used to treat chronic inflammatory disorders have been found to increase the risk of major cardiovascular problems (such as heart attack or stroke), cancer, blood clots in the lungs and in deep veins, serious infections and death when compared with TNF alpha inhibitors. These JAK inhibitors (Xeljanz, Cibinqo, Olumiant, Rinvoq and Jyseleca) are used to treat one or more of the following chronic inflammatory disorders: rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, ulcerative colitis, atopic dermatitis and alopecia areata. If you are aged 65 years or above, have an increased risk of major cardiovascular problems or cancer or if you smoke or have done so for a long time in the past, you should only be prescribed these medicines if there are no suitable treatment alternatives for you. If you have certain risk factors, your doctor may reduce the dose of your JAK inhibitor or switch treatment depending on your inflammatory disorder and the JAK inhibitor you are taking to treat it. If, at any stage during your treatment, you experience chest pain or tightness (which may spread to arms, jaw, neck and back), shortness of breath, cold sweat, light headedness, sudden dizziness, weakness in arms and legs or slurred speech, contact your doctor immediately. Examine your skin periodically and let your doctor know if you notice any new growths on the skin. If you have any questions about your treatment, speak to your doctor. Information for healthcare professionals An EMA review has found that, compared with TNF-alpha inhibitors, Janus kinase (JAK) inhibitors used to treat chronic inflammatory disorders (rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, ulcerative colitis, atopic dermatitis and alopecia areata) are linked to a higher risk of major adverse cardiovascular events (MACE), venous thromboembolism (VTE), malignancy, serious infections and all-cause mortality. The review included the final results from an open-label clinical trial (ORAL Surveillance study) 1 of the JAK inhibitor Xeljanz (tofacitinib) in patients with rheumatoid arthritis and cardiovascular risk factors which found a higher risk of these events with Xeljanz than with TNF-alpha inhibitors. Preliminary findings from an observational study (B023) involving another JAK inhibitor, Olumiant (baricitinib), also suggest an increased risk of MACE and VTE in patients with rheumatoid arthritis treated with Olumiant compared with those treated with TNF-alpha inhibitors. EMA concluded that the identified risks apply to all JAK inhibitors approved for the treatment of chronic inflammatory disorders. These medicines (Xeljanz, Cibinqo, Olumaint, Rinvoq and Jyseleca) should only be used in the following patients if no suitable treatment alternatives are available: those aged 65 years or above, those who are current or past long-time smokers, those with a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors, or those with other malignancy risk factors. Cautious use is also recommended in patients with known risk factors for VTE other than those listed above. If JAK inhibitors are needed in patients with these risk factors, a lower dose may be recommended, depending on the medicine, the indication and the specific risk factor. Healthcare professionals should discuss the risks associated with JAK inhibitors with their patients. It is recommended that healthcare professionals carry out periodic examinations of their patients’ skin to check for skin cancer, particularly for patients at risk for skin cancer. Aletter will be sent to all healthcare professionals expected to prescribe these medicines to inform them of the outcome of the review.Full treatment recommendations will be included in the updated summary of product characteristics and the educational material for the respective products. More about the medicines The Janus kinase inhibitors subject to this review are Cibinqo (abrocitinib), Jyseleca (filgotinib), Olumiant (baricitinib), Rinvoq (upadacitinib) and Xeljanz (tofacitinib). These medicines are used to treat several chronic inflammatory disorders (rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, ulcerative colitis, atopic dermatitis and alopecia areata). The active substances in these medicines work by blocking the action of enzymes known as Janus kinases. These enzymes play an important role in the process of inflammation that occurs in these disorders. By blocking the enzymes’ action, the medicines help reduce the inflammation and other symptoms of these disorders. Some JAK inhibitors (Jakavi and Inrebic) are used to treat myeloproliferative disorders; the review did not include these medicines. The review also did not cover the use of Olumiant in the short-term treatment of COVID-19, which is under assessment by EMA. More about the procedure The review of JAK inhibitors in the treatment of inflammatory disorders was initiated at the request of the European Commission (EC) under Article 20 of Regulation (EC) No 726/2004 . The review was carried out by the Pharmacovigilance Risk Assessment Committee ( PRAC ), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations. The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use ( CHMP ), responsible for questions concerning medicines for human use, which adopted the Agency’s opinion. The final stage of the review procedure is the adoption by the EC of a legally binding decision applicable in all EU Member States. 1 Ytterberg SR, et al. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. New Engl J Med 2022; 3 86(4):316-326. doi: 10.1056/NEJMoa2109927