Optic Nerve Diseases

ZUG, Switzerland, May 01, 2025 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS / ICX: OCS.IC) (“Oculis”), a global biopharmaceutical company focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs, today announced upcoming presentations highlighting its innovative late-stage pipeline at Eyecelerator 2025, the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting and the Retina World Congress (RWC). The presentation of the DME AWARE Delphi Study interim results will highlight key areas of consensus on unmet needs in DME patient management among leading global experts. Further insights from Stage 1 of the Phase 3 DIAMOND program reinforcing the efficacy and safety profile of OCS-01 eye drops for DME will also be shared. OCS-01 is being developed to be the first non-invasive treatment for DME, addressing key unmet needs for earlier treatment intervention and for inadequate responders to the current standard of care. Data from the Phase 2b RELIEF trial investigating Licaminlimab (OCS-02) in signs of DED will be presented following positive and consistent results from phase 2 trials in symptoms. The genetic biomarker, previously identified, to predict response to Licaminlimab, enables the first genotype-based development plan to drive a personalized approach in dry eye disease (DED). Licaminlimab is being developed to transform the treatment paradigm in DED, currently driven by trial and error, and address unmet medical needs for this multifactorial disease with a dissatisfied patient population. Details of the presentations are as follows: Eyecelerator 2025 Company showcases – Retina: TKI and Drug Delivery Presenter: Sharon Klier, M.D., Chief Development Officer Date/Time: Friday, May 2, 2025, 1:30 PM – 3:00 PM MST ARVO Annual Meeting 2025 Interim results of the DME AWARE Delphi Study on unmet needs in DME patient management Presenter: Anat Loewenstein, M.D., MHA Session: #261 Presentation: #2587 Posterboard: #B0300 Date/Time: Monday, May 5, 2025, 3:00 PM – 4:45 PM MSTBCVA and CST Improvement over 12 weeks with OCS-01 Eye Drops in DME from DIAMOND Stage 1 trial Presenter: Carl Danzig, M.D. Session: 401 Presentation: #4011 Location: Room #255ABC Date/Time: Wednesday, May 7, 2025, 10:15 AM – 12:00 PM MSTLicaminlimab in the treatment of dry eye disease Presenter: Anat Galor, M.D., MSPH Session: #513 Presentation: #5682 Posterboard: #B0077 Date/Time: Thursday, May 8, 2025, 8:00 AM – 9:45 AM MST Retina World Congress 2025 Wet AMD, DR, RVO – Part 2, Panel Discussion Participant: Riad Sherif, M.D., Chief Executive Officer Date/Time: Thursday, May 8, 2025, 11:25 AM – 11:59 AM ETBCVA and CST Improvement over 12 weeks with OCS-01 Eye Drops in DME From DIAMOND-Stage 1 trial Presenter: David Almeida, M.D., PhD Date/Time: Thursday, May 8, 2025, 6:08 PM – 6:13 PM ET Anat Loewenstein, M.D., MHA, is Professor and Head of Retina, Division of Ophthalmology Tel Aviv Medical Center, VP Ambulatory Services Tel Aviv Medical Center, Sidney Fox Chair of Ophthalmology at the Sackler Faculty of Medicine at Tel Aviv University, and President of the EURETINA. In addition to being a member of Oculis’ DIAMOND Steering Committee, Dr. Loewenstein serves as a member of Oculis’ Scientific Advisory Board. Her main field of interest is the investigation of drug administration and toxicity to the retina, early detection of macular degeneration and home monitoring of retinal disease. She currently serves as the Editor in Chief of the Journal Case Reports in Ophthalmology, is an associate editor of Investigative Ophthalmology & Visual Science Journal, European Journal of Ophthalmology, and of Ophthalmologica. Professor Loewenstein published more than 500 papers in peer reviewed journals and contributed multiple chapters to ophthalmology textbooks. She is also actively involved as a leader in mentorship programs for young retina specialists including the mentorship educational programs of ARVO and EURETINA. Carl Danzig, M.D., is the Director of Vitreoretinal Services and Retina Clinical Research at Rand Eye Institute in Deerfield Beach, FL, where he has been practicing since September 2011. In private practice, he founded the retina department at Rand Eye Institute and served as Principal Investigator in dozens of clinical trials. In addition, Dr. Danzig has frequently presented his research at various international ophthalmology meetings. He is also an Affiliate Assistant Professor of Clinical Biomedical Science at the Charles E. Schmidt School of Medicine at Florida Atlantic University in Boca Raton, FL. Recently, Dr. Danzig completely five years serving on the ONE network, retina division for the American Academy of Ophthalmology. Dr. Danzig spent his undergraduate years in New Orleans, LA at Tulane University, receiving a B.A. in Philosophy in 2000. He returned to his hometown for medical school at Temple University and stayed in Philadelphia for his internship along with a year of ocular oncology research at Wills Eye Hospital. Dr. Danzig completed his residency in ophthalmology at SUNY-Downstate Medical Center in Brooklyn, NY and went on to fellowship training in vitreoretinal surgery at University of Texas-Southwestern Medical Center in Dallas, TX. Anat Galor, M.D., is a cornea and uveitis trained specialist with a dual appointment at the Bascom Palmer Eye Institute and the Miami VA medical center. Dr. Galor completed an ophthalmology residency at the Cole Eye Cleveland Clinic, a uveitis fellowship at the Wilmer Eye Institute, and a cornea and external diseases fellowship at Bascom Palmer Eye Institute. Dr. Galor currently runs the ocular surface program at the Miami VA and has focused her research on understanding mechanisms of pain in dry eye, with an emphasis on studying new diagnostic and treatment modalities. Some of her research focused on how ocular surface symptoms, including pain, affect the quality of life. She has brought to light the role of nerve dysfunction in dry eye and has developed novel diagnostic and therapeutic metrics to address dry eye symptoms and ocular pain due to nerve sensitization. She first demonstrated that symptoms and signs of dry eye were often discordant. This observation prompted her to study whether nerve dysfunction was the missing link between the observed discordance. She demonstrated that many symptoms of dry eye, such as burning and sensitivity to wind and light, were shared with chronic pain conditions outside the eye. She has published her work in high-impact ophthalmology and pain journals. Dr. Galor was named to The Ophthalmologist Power List 2021.David R.P. Almeida, M.D., M.BA., Ph.D., FRCSC, DABO, is a highly accomplished vitreoretinal surgeon and researcher with extensive experience in ophthalmic and vitreoretinal studies. As Executive Chairman of Erie Retina Research and The Centers for Advanced Surgical Exploration (CASEx), Dr. Almeida leads innovative clinical research initiatives across multiple international sites. Dr. Almeida is a recognized thought leader in the field with over 300 peer-reviewed publications and more than 125 presentations at major conferences. His research interests span age-related macular degeneration, diabetic eye disease, complex surgery, and practice efficiency. As Principal Investigator, he has led over 100 clinical trials across all phases of development on three continents. Recognized for his expertise, Dr. Almeida has received numerous awards, including the American Society of Retina Specialists (ASRS) Honor Award, and has been named to The Ophthalmologist Power List Top 50 Rising Stars in Ophthalmology. Dr. Almeida’s academic background includes an Honors Bachelor of Science from the University of Toronto, a Ph.D. in pharmaceutical research from the University of Szeged, and an MBA in healthcare management from George Washington University. He completed medical school (Queen’s University, Canada), ophthalmology residency (Queen’s University, Canada), and a vitreoretinal diseases and surgery fellowship (University of Iowa, USA). - END - About OCS-01 eye drops and the OPTIREACH® technology Leveraging Oculis’ proprietary technology, OCS-01 is an OPTIREACH® formulation of high concentration dexamethasone eye drop. It is being developed as an eye drop to treat the retina to offer a non-invasive treatment alternative for diabetic macular edema (DME). This route of administration enables easy access to treatment in the early stages of the disease and can be used in combination with other therapies in later stages. In contrast, all currently available treatments require invasive delivery methods, such as intravitreal injections or ocular implants, to reach the retina. 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 the drug passage from the eye surface to the posterior segment of the eye. Oculis’ OCS-01 is being developed with the aim to transform the current treatment paradigm in DME as a non-invasive topical treatment option. OCS-01 is an investigational drug in Phase 3 that has not received regulatory approval for commercial use in any country. About Diabetic Macular Edema (DME) DME is the leading cause of visual loss and legal blindness in patients with diabetes. Currently, it is estimated to affect around 37 million people worldwide and, with the rise of diabetes, the prevalence is expected to increase to 53 million by 20401,2. DME is an irreversible and progressive complication of diabetic retinopathy and is related to consistently having high blood sugar levels that damage nerves and blood vessels in the macula, the area of the retina responsible for sharp vision. DME occurs when blood vessels in the retina swell, and then leak, leading to a fluid build-up (edema) into the retina. There remains a significant need for safe, efficacious, and less burdensome treatments for DME patients. About Licaminlimab (OCS-02)Licaminlimab is an anti-TNFα eye drop candidate being developed with a single chain antibody fragment (scFv) technology specifically designed to treat ocular inflammatory diseases. The dual anti-inflammatory and anti-necrotic mechanism of action of TNF-α inhibition has been well-established in inflammatory disorders where the systemic use of TNF-α inhibitors has led to marked improvements in the disease management and treatment outcomes. In Phase 2 trials, Licaminlimab has shown a positive treatment effect on both the signs and symptoms of DED and has been well tolerated. In addition, a genetic biomarker has been identified which showed an improved response to Licaminlimab in patients with a variant in the TNFR1 gene. Licaminlimab is an investigational drug in Phase 2 and has not received regulatory approval for commercial use in any country. About Dry Eye Disease (DED) DED is a common condition estimated to impact more than 110 million people in the G7 countries (U.S., U.K., Germany, France, Spain, Italy, Japan) and 40 million people in the U.S. alone3. It is a multifactorial disease in which ocular surface inflammation plays a central role in sustaining the pathological state4,5. It usually affects both eyes and patients may experience a stinging, burning or scratchy sensation. In addition, some patients experience sensitivity to light, eye redness, difficulty wearing contact lenses, difficulty with nighttime driving, and blurred vision which can greatly affect their quality of life. Of the approximately 20 million patients who are diagnosed with DED in the U.S., about half or 10 million are considered to have moderate to severe disease3. However, only 13% receive prescription treatment, primarily with an anti-inflammatory medications3. Despite currently available treatments, 87% of chronic patients still unsatisfied6 highlighting the tremendous unmet need remaining in this underserved patient population. Furthermore, given the heterogenicity of the DED patient population, there is a need for personalized treatment approaches to improve outcomes for patients. About Oculis Oculis is a global biopharmaceutical company (Nasdaq: OCS / XICE: OCS) focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs. Oculis’ highly differentiated pipeline of multiple innovative product candidates in clinical development includes: OCS-01, a topical eye drop candidate for diabetic macular edema (DME); Privosegtor (OCS-05), a neuroprotective candidate for acute optic neuritis with potentially broad clinical applications in other neuro-ophthalmic diseases; and Licaminlimab (OCS-02), a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is led by an experienced management team with a successful track record and is supported by leading international healthcare investors.For more information, please visit: www.oculis.com -ENDS- Oculis ContactsMs. Sylvia Cheung, CFOsylvia.cheung@oculis.com Investor Relations LifeSci AdvisorsCorey Davis, Ph.D.cdavis@lifesciadvisors.com Media RelationsICR HealthcareAmber Fennell / David Daley / Sean Leousoculis@icrhealthcare.com 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 and Licaminlimab (OCS-02), including patient impact and market opportunity; the potential of OCS-01 to transform the treatment paradigm in DME as a non-invasive topical treatment option; the potential of Licaminlimab (OCS-02) to transform the treatment paradigm in DED; the initiation, timing, progress and results of Oculis’ clinical trials; Oculis’ research and development programs, regulatory and business strategy and future development plans; and Oculis’ ability to advance product candidates into, and successfully complete, clinical trials, 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 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. Yau et al. Global Prevalence and Major Risk Factors of Diabetic Retinopathy, Diabetes Care 2012 Mar; 35(3): 556-564International Diabetes Federation – diabetesatlas.org Estimated diabetes prevalence worldwide in 2021: 537m, reaching 783m in 2045DRG (part of Clarivate) – Dry Eye Disease Landscape and Forecast report 2020TFOS DEWS II The Ocular Surface 15 (2017)Baudouin C. Dry Eye Disease, the complex interactions of vicious cycles. EuDES European Dry Eye Society https://www.dryeye-society.com/resources/dry-eye-disease-complex-interactions-vicious-cycles Mukamal, R. Why is Dry Eye So Difficult to Treat? 2021 https://www.aao.org/eye-health/tips-prevention/fix-dry-eye-treatment-eyedrops

ZUG, Switzerland, May 01, 2025 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS / ICX: OCS.IC) (“Oculis”), a global biopharmaceutical company focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs, today announced upcoming presentations highlighting its innovative late-stage pipeline at Eyecelerator 2025, the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting and the Retina World Congress (RWC). The presentation of the DME AWARE Delphi Study interim results will highlight key areas of consensus on unmet needs in DME patient management among leading global experts. Further insights from Stage 1 of the Phase 3 DIAMOND program reinforcing the efficacy and safety profile of OCS-01 eye drops for DME will also be shared. OCS-01 is being developed to be the first non-invasive treatment for DME, addressing key unmet needs for earlier treatment intervention and for inadequate responders to the current standard of care. Data from the Phase 2b RELIEF trial investigating Licaminlimab (OCS-02) in signs of DED will be presented following positive and consistent results from phase 2 trials in symptoms. The genetic biomarker, previously identified, to predict response to Licaminlimab, enables the first genotype-based development plan to drive a personalized approach in dry eye disease (DED). Licaminlimab is being developed to transform the treatment paradigm in DED, currently driven by trial and error, and address unmet medical needs for this multifactorial disease with a dissatisfied patient population. Details of the presentations are as follows: Eyecelerator 2025 Company showcases – Retina: TKI and Drug Delivery Presenter: Sharon Klier, M.D., Chief Development Officer Date/Time: Friday, May 2, 2025, 1:30 PM – 3:00 PM MST ARVO Annual Meeting 2025 Interim results of the DME AWARE Delphi Study on unmet needs in DME patient management Presenter: Anat Loewenstein, M.D., MHA Session: #261 Presentation: #2587 Posterboard: #B0300 Date/Time: Monday, May 5, 2025, 3:00 PM – 4:45 PM MST BCVA and CST Improvement over 12 weeks with OCS-01 Eye Drops in DME from DIAMOND Stage 1 trial Presenter: Carl Danzig, M.D. Session: 401 Presentation: #4011 Location: Room #255ABC Date/Time: Wednesday, May 7, 2025, 10:15 AM – 12:00 PM MST Licaminlimab in the treatment of dry eye disease Presenter: Anat Galor, M.D., MSPH Session: #513 Presentation: #5682 Posterboard: #B0077 Date/Time: Thursday, May 8, 2025, 8:00 AM – 9:45 AM MST Retina World Congress 2025 Wet AMD, DR, RVO – Part 2, Panel Discussion Participant: Riad Sherif, M.D., Chief Executive Officer Date/Time: Thursday, May 8, 2025, 11:25 AM – 11:59 AM ET BCVA and CST Improvement over 12 weeks with OCS-01 Eye Drops in DME From DIAMOND-Stage 1 trial Presenter: David Almeida, M.D., PhD Date/Time: Thursday, May 8, 2025, 6:08 PM – 6:13 PM ET Anat Loewenstein, M.D., MHA, is Professor and Head of Retina, Division of Ophthalmology Tel Aviv Medical Center, VP Ambulatory Services Tel Aviv Medical Center, Sidney Fox Chair of Ophthalmology at the Sackler Faculty of Medicine at Tel Aviv University, and President of the EURETINA. In addition to being a member of Oculis’ DIAMOND Steering Committee, Dr. Loewenstein serves as a member of Oculis’ Scientific Advisory Board. Her main field of interest is the investigation of drug administration and toxicity to the retina, early detection of macular degeneration and home monitoring of retinal disease. She currently serves as the Editor in Chief of the Journal Case Reports in Ophthalmology, is an associate editor of Investigative Ophthalmology & Visual Science Journal, European Journal of Ophthalmology, and of Ophthalmologica. Professor Loewenstein published more than 500 papers in peer reviewed journals and contributed multiple chapters to ophthalmology textbooks. She is also actively involved as a leader in mentorship programs for young retina specialists including the mentorship educational programs of ARVO and EURETINA. Carl Danzig, M.D., is the Director of Vitreoretinal Services and Retina Clinical Research at Rand Eye Institute in Deerfield Beach, FL, where he has been practicing since September 2011. In private practice, he founded the retina department at Rand Eye Institute and served as Principal Investigator in dozens of clinical trials. In addition, Dr. Danzig has frequently presented his research at various international ophthalmology meetings. He is also an Affiliate Assistant Professor of Clinical Biomedical Science at the Charles E. Schmidt School of Medicine at Florida Atlantic University in Boca Raton, FL. Recently, Dr. Danzig completely five years serving on the ONE network, retina division for the American Academy of Ophthalmology. Dr. Danzig spent his undergraduate years in New Orleans, LA at Tulane University, receiving a B.A. in Philosophy in 2000. He returned to his hometown for medical school at Temple University and stayed in Philadelphia for his internship along with a year of ocular oncology research at Wills Eye Hospital. Dr. Danzig completed his residency in ophthalmology at SUNY-Downstate Medical Center in Brooklyn, NY and went on to fellowship training in vitreoretinal surgery at University of Texas-Southwestern Medical Center in Dallas, TX. Anat Galor, M.D., is a cornea and uveitis trained specialist with a dual appointment at the Bascom Palmer Eye Institute and the Miami VA medical center. Dr. Galor completed an ophthalmology residency at the Cole Eye Cleveland Clinic, a uveitis fellowship at the Wilmer Eye Institute, and a cornea and external diseases fellowship at Bascom Palmer Eye Institute. Dr. Galor currently runs the ocular surface program at the Miami VA and has focused her research on understanding mechanisms of pain in dry eye, with an emphasis on studying new diagnostic and treatment modalities. Some of her research focused on how ocular surface symptoms, including pain, affect the quality of life. She has brought to light the role of nerve dysfunction in dry eye and has developed novel diagnostic and therapeutic metrics to address dry eye symptoms and ocular pain due to nerve sensitization. She first demonstrated that symptoms and signs of dry eye were often discordant. This observation prompted her to study whether nerve dysfunction was the missing link between the observed discordance. She demonstrated that many symptoms of dry eye, such as burning and sensitivity to wind and light, were shared with chronic pain conditions outside the eye. She has published her work in high-impact ophthalmology and pain journals. Dr. Galor was named to The Ophthalmologist Power List 2021. David R.P. Almeida, M.D., M.BA., Ph.D., FRCSC, DABO, is a highly accomplished vitreoretinal surgeon and researcher with extensive experience in ophthalmic and vitreoretinal studies. As Executive Chairman of Erie Retina Research and The Centers for Advanced Surgical Exploration (CASEx), Dr. Almeida leads innovative clinical research initiatives across multiple international sites. Dr. Almeida is a recognized thought leader in the field with over 300 peer-reviewed publications and more than 125 presentations at major conferences. His research interests span age-related macular degeneration, diabetic eye disease, complex surgery, and practice efficiency. As Principal Investigator, he has led over 100 clinical trials across all phases of development on three continents. Recognized for his expertise, Dr. Almeida has received numerous awards, including the American Society of Retina Specialists (ASRS) Honor Award, and has been named to The Ophthalmologist Power List Top 50 Rising Stars in Ophthalmology. Dr. Almeida’s academic background includes an Honors Bachelor of Science from the University of Toronto, a Ph.D. in pharmaceutical research from the University of Szeged, and an MBA in healthcare management from George Washington University. He completed medical school (Queen’s University, Canada), ophthalmology residency (Queen’s University, Canada), and a vitreoretinal diseases and surgery fellowship (University of Iowa, USA). About OCS-01 eye drops and the OPTIREACH® technology Leveraging Oculis’ proprietary technology, OCS-01 is an OPTIREACH® formulation of high concentration dexamethasone eye drop. It is being developed as an eye drop to treat the retina to offer a non-invasive treatment alternative for diabetic macular edema (DME). This route of administration enables easy access to treatment in the early stages of the disease and can be used in combination with other therapies in later stages. In contrast, all currently available treatments require invasive delivery methods, such as intravitreal injections or ocular implants, to reach the retina. 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 the drug passage from the eye surface to the posterior segment of the eye. Oculis’ OCS-01 is being developed with the aim to transform the current treatment paradigm in DME as a non-invasive topical treatment option. OCS-01 is an investigational drug in Phase 3 that has not received regulatory approval for commercial use in any country. About Diabetic Macular Edema (DME) DME is the leading cause of visual loss and legal blindness in patients with diabetes. Currently, it is estimated to affect around 37 million people worldwide and, with the rise of diabetes, the prevalence is expected to increase to 53 million by 20401,2. DME is an irreversible and progressive complication of diabetic retinopathy and is related to consistently having high blood sugar levels that damage nerves and blood vessels in the macula, the area of the retina responsible for sharp vision. DME occurs when blood vessels in the retina swell, and then leak, leading to a fluid build-up (edema) into the retina. There remains a significant need for safe, efficacious, and less burdensome treatments for DME patients. About Licaminlimab (OCS-02) Licaminlimab is an anti-TNFα eye drop candidate being developed with a single chain antibody fragment (scFv) technology specifically designed to treat ocular inflammatory diseases. The dual anti-inflammatory and anti-necrotic mechanism of action of TNF-α inhibition has been well-established in inflammatory disorders where the systemic use of TNF-α inhibitors has led to marked improvements in the disease management and treatment outcomes. In Phase 2 trials, Licaminlimab has shown a positive treatment effect on both the signs and symptoms of DED and has been well tolerated. In addition, a genetic biomarker has been identified which showed an improved response to Licaminlimab in patients with a variant in the TNFR1 gene. Licaminlimab is an investigational drug in Phase 2 and has not received regulatory approval for commercial use in any country. About Dry Eye Disease (DED) DED is a common condition estimated to impact more than 110 million people in the G7 countries (U.S., U.K., Germany, France, Spain, Italy, Japan) and 40 million people in the U.S. alone3. It is a multifactorial disease in which ocular surface inflammation plays a central role in sustaining the pathological state4,5. It usually affects both eyes and patients may experience a stinging, burning or scratchy sensation. In addition, some patients experience sensitivity to light, eye redness, difficulty wearing contact lenses, difficulty with nighttime driving, and blurred vision which can greatly affect their quality of life. Of the approximately 20 million patients who are diagnosed with DED in the U.S., about half or 10 million are considered to have moderate to severe disease3. However, only 13% receive prescription treatment, primarily with an anti-inflammatory medications3. Despite currently available treatments, 87% of chronic patients still unsatisfied6 highlighting the tremendous unmet need remaining in this underserved patient population. Furthermore, given the heterogenicity of the DED patient population, there is a need for personalized treatment approaches to improve outcomes for patients. About Oculis Oculis is a global biopharmaceutical company (Nasdaq: OCS / XICE: OCS) focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs. Oculis’ highly differentiated pipeline of multiple innovative product candidates in clinical development includes: OCS-01, a topical eye drop candidate for diabetic macular edema (DME); Privosegtor (OCS-05), a neuroprotective candidate for acute optic neuritis with potentially broad clinical applications in other neuro-ophthalmic diseases; and Licaminlimab (OCS-02), a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED). Headquartered in Switzerland with operations in the U.S. and Iceland, Oculis is led by an experienced management team with a successful track record and is 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 Relations LifeSci Advisors Corey Davis, Ph.D. cdavis@lifesciadvisors.com Media Relations ICR Healthcare Amber Fennell / David Daley / Sean Leous oculis@icrhealthcare.com 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 and Licaminlimab (OCS-02), including patient impact and market opportunity; the potential of OCS-01 to transform the treatment paradigm in DME as a non-invasive topical treatment option; the potential of Licaminlimab (OCS-02) to transform the treatment paradigm in DED; the initiation, timing, progress and results of Oculis’ clinical trials; Oculis’ research and development programs, regulatory and business strategy and future development plans; and Oculis’ ability to advance product candidates into, and successfully complete, clinical trials, 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 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. (1) Yau et al. Global Prevalence and Major Risk Factors of Diabetic Retinopathy, Diabetes Care 2012 Mar; 35(3): 556-564 (2) International Diabetes Federation – diabetesatlas.org Estimated diabetes prevalence worldwide in 2021: 537m, reaching 783m in 2045 (3) DRG (part of Clarivate) – Dry Eye Disease Landscape and Forecast report 2020 (4) TFOS DEWS II The Ocular Surface 15 (2017) (5) Baudouin C. Dry Eye Disease, the complex interactions of vicious cycles. EuDES European Dry Eye Society https://www.dryeye-society.com/resources/dry-eye-disease-complex-interactions-vicious-cycles (6) Mukamal, R. Why is Dry Eye So Difficult to Treat? 2021 https://www.aao.org/eye-health/tips-prevention/fix-dry-eye-treatment-eyedrops

Six abstracts accepted for presentation includes post hoc analyses and real-world evidence for ZYMFENTRA® (infliximab-dyyb) Findings reinforce clinical decision-making in long-term management of moderate-to-severe Crohn's disease and ulcerative colitis and underscore Celltrion's commitment to advancing scientific understanding in the field of IBD Findings reinforce clinical decision-making in long-term management of moderate-to-severe Crohn's disease and ulcerative colitis and underscore Celltrion's commitment to advancing scientific understanding in the field of IBD INCHEON, South Korea, April 28, 2025 -- Celltrion, Inc. today announced that six abstracts will be presented at the 2025 Digestive Disease Week® (DDW) Annual Meeting, taking place May 3-6 in San Diego, California. The oral and poster presentations will feature data including post hoc analyses of its pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) of ZYMFENTRA®, the first and only FDA-approved subcutaneous infliximab. "We are excited by the opportunity to present further analyses reinforcing ZYMFENTRA's clinical value for HCPs and patients," said Hetal Patel, PharmD MBA, Vice President of Medical Affairs at Celltrion USA. "With IBD management becoming increasingly individualized, we anticipate these analyses will help clarify how ZYMFENTRA performs across a wide range of patient types, from long-term drug persistence to recapture following dose escalation." The presentations reflect Celltrion's continued commitment to making comprehensive clinical and real-world evidence accessible to healthcare professionals in the U.S., supporting informed treatment decisions in a complex and evolving IBD landscape. The details of Celltrion's abstract presentations are as follows: Abstract Title Presentation Details All times PDT Endoscopic and histologic outcomes in patients with moderate-to-severe ulcerative colitis treated with subcutaneous infliximab: A post hoc analysis of the LIBERTY-UC study Poster Presentation #0035 IMIBD_POS: IBD: Controlled Clinical Trials in Humans Sunday May 4, 2025 / 12:30-13:30 Time to clinical recapture after dose escalation of subcutaneous infliximab following loss of response: A post hoc analysis of the 2-year Phase 3 LIBERTY-CD & LIBERTY-UC trials Poster Presentation #0016 IMIBD_POS: IBD: Controlled Clinical Trials in Humans Sunday May 4, 2025 / 12:30-13:30 Efficacy of subcutaneous infliximab maintenance therapy according to disease location in patients with moderate-to-severe Crohn's disease: A post hoc analysis of the Phase 3 LIBERTY-CD study Poster Presentation #0039 IMIBD_POS: IBD: Controlled Clinical Trials in Humans Sunday May 4, 2025 / 12:30-13:30 Impact of immunogenicity on 2-year clinical outcomes in patients with moderate-to-severe Crohn's disease treated with subcutaneous infliximab: A post hoc analysis of the Phase 3 LIBERTY-CD study Poster Presentation #0011 IMIBD_POS: IBD: Controlled Clinical Trials in Humans Sunday May 4, 2025 / 12:30-13:30 Characterization of patients who experience loss of response during maintenance treatment with subcutaneous infliximab: A post hoc analysis of the 2-year Phase 3 LIBERTY-CD & LIBERTY-UC trials Poster Presentation #0017 IMIBD_POS: IBD: Controlled Clinical Trials in Humans Sunday May 4, 2025 / 12:30-13:30 Nationwide population-based cohort study on the use and persistence of infliximab IV and SC in France: Riposte IBD study Poster Presentation #0014 IMIBD_POS: IBD: Comparative Effectiveness Studies Tuesday May 6, 2025 / 12:30-13:30 Notes to Editors: About ZYMFENTRA® (infliximab-dyyb) ZYMFENTRA® (infliximab-dyyb) is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of moderately-to-severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV), Moderately-to-severely active Crohn's disease following treatment with an infliximab product given by intravenous infusion (IV). ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body. ZYMFENTRA was approved by the FDA through the Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a "stand-alone" BLA). ZYMFENTRA is considered a new biologic with a first-approved subcutaneous administration form and thus will be under patent protection for its dosage form by 2037 and for its route of administration by 2040. Indication and Important Safety Information ZYMFENTRA® is a prescription medicine indicated in adults for maintenance treatment of: Moderately-to-severely active Crohn's disease following treatment with an infliximab product administered intravenously. Moderately-to-severely active ulcerative colitis following treatment with an infliximab product administered intravenously. Moderately-to-severely active ulcerative colitis following treatment with an infliximab product administered intravenously. It is not known if ZYMFENTRA is safe and effective in children under 18 years of age. What is the most important information I should know about ZYMFENTRA? SERIOUS INFECTIONS Patients treated with ZYMFENTRA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with ZYMFENTRA. Treatment for latent infection should be initiated prior to treatment with ZYMFENTRA. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. The risks and benefits of treatment with ZYMFENTRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with ZYMFENTRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Risk of infection may be higher in patients greater than 65 years of age, patients with comorbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab included arthritis bacterial, pneumonia, and urinary tract infection. MALIGNANCIES Malignancies, some fatal, have been reported in children, adolescents, and young adults treated with TNF blockers, including infliximab products. Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants. Post-marketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn's disease or ulcerative colitis, and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with ZYMFENTRA, especially in these patient types. In clinical trials of all TNF blockers, more cases of malignancies were observed compared with controls and the expected rate in the general population. In clinical trials of some TNF blockers, including infliximab products, more cases of other malignancies were observed compared with controls. As the potential role of TNF blocker therapy in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. CONTRAINDICATIONS ZYMFENTRA is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients of ZYMFENTRA or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension and serum sickness). HEPATITIS B VIRUS REACTIVATION TNF blockers, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating ZYMFENTRA. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing ZYMFENTRA for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with ZYMFENTRA. Discontinue ZYMFENTRA in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of ZYMFENTRA and monitor patients closely. HEPATOTOXICITY Hepatobiliary disorders, including acute liver failure, jaundice abnormal hepatic function, hepatic steatosis, hepatitis, hepatotoxicity, hyperbilirubinemia and non-alcoholic fatty liver, have been reported in patients receiving infliximab products post-marketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, ZYMFENTRA should be discontinued and a thorough investigation of the abnormality should be undertaken. CONGESTIVE HEART FAILURE Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Some cases had a fatal outcome. In several exploratory trials of other TNF blockers in the treatment of CHF, there were greater proportions of TNF-blocker-treated patients who had CHF exacerbations requiring hospitalization or increased mortality. ZYMFENTRA has not been studied in patients with a history of CHF and ZYMFENTRA should be used with caution in patients with CHF. HEMATOLOGIC REACTION Cases of leukopenia, neutropenia, thrombocytopenia and pancytopenia (some fatal) have been reported. The causal relationship to infliximab-product therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of ZYMFENTRA in patients who develop significant hematologic abnormalities. HYPERSENSITIVITY AND OTHER ADMINISTRATION REACTIONS In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylaxis, hypotension and serum sickness) have been reported following administration of infliximab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA. INJECTION SITE REACTIONS In clinical studies, localized injection-site reactions were reported following administration of ZYMFENTRA. If a clinically significant injection-site reaction occurs, institute appropriate therapy and discontinue ZYMFENTRA. NEUROLOGIC REACTIONS Agents that inhibit TNF have been associated with central nervous system (CNS) manifestation of systemic vasculitis, seizure and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering ZYMFENTRA in patients with these disorders and consider discontinuation if these disorders develop. RISK OF INFECTION WITH CONCURRENT ADMINISTRATION OF OTHER BIOLOGICS PRODUCTS Serious infections and neutropenia have been reported with concurrent use of ZYMFENTRA with other immunosuppressive biological products. The concurrent use of ZYMFENTRA with other immunosuppressive biological products used to treat UC and CD may increase the risk of infection and is not recommended. RISK OF ADDITIVE IMMUNOSUPPRESSIVE EFFECTS FROM PRIOR BIOLOGICAL PRODUCTS Consider the half-life and mode of action of prior biological products to avoid unintended additive immunosuppressive effects when initiating ZYMFENTRA. AUTOIMMUNITY Treatment with TNF blockers may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue ZYMFENTRA treatment if symptoms of a lupus-like syndrome develop. VACCINATIONS AND USE OF LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS Prior to initiating ZYMFENTRA, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with ZYMFENTRA due to the possibility of clinical infections, including disseminated infections. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to ZYMFENTRA. ADVERSE REACTIONS In clinical trials with ZYMFENTRA, the most common adverse reactions occurring in ≥3% of ZYMFENTRA-treated patients included site reactions, COVID-19, anemia, arthralgia, infection site reaction, increased alanine aminotransferase and abdominal pain for UC, and COVID-19, headache, upper respiratory tract infection, injection site reaction, diarrhea, increased blood creatine phosphokinase, arthralgia, increased alanine aminotransferase, hypertension, urinary tract infection, neutropenia, dizziness and leukopenia for CD. Please click for Full U.S. Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About Digestive Disease Week® Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 3-6, 2025. The meeting showcases more than 5,600 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org About Celltrion, Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website www.celltrion.com/en-us. and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba), STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo) and OMLYCLO® (omalizumab-igec), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit www.celltrionusa.com and stay updated with our latest news and events on our social media: LinkedIn. FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", "anticipate" the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws.