Uveitis

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

PALO ALTO, Calif., May 1, 2025 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases, announced today that seven scientific presentations on its research programs will be made at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting, being held from May 4-8 in Salt Lake City, Utah. "We are pleased to share new data from Kodiak's research and development efforts at this year's ARVO meeting. This body of work further highlights the power and versatility of Kodiak's ABC® (Antibody Biopolymer Conjugate) platform for the design and development of new medicines for complex multifactorial diseases with a high unmet need," said Dr. Victor Perlroth, MD and Chief Executive Officer. "Our bispecific protein platform, the basis for KSI-101 currently in clinical development for macular edema secondary to inflammation (MESI), is fueling two new research programs in two new therapeutic categories: ocular inflammatory disease and geographic atrophy. We also present new data from our ABC® platform extension in which we embed diverse therapeutic payloads, such as oligonucleotides and peptides, into the biopolymer backbone at a high drug-antibody ratio (DAR) and deliver these payloads into targeted cells. We believe this is a promising strategy to power a next generation of targeted, high-DAR, multi-specific and multi-modality therapeutic candidates with relevance for retinal and systemic diseases." The seven poster presentations are listed below, grouped by topic. The posters will also be made available under Kodiak's "Scientific Presentations" page on kodiak.com. Ocular Inflammatory Disease Ocular inflammatory disease, often called uveitis, is the fourth leading cause of vision loss for working aged adults in the developed world. One-third of patients with ocular inflammation develop macular edema, which is the leading cause of vision loss among patients with ocular inflammation. Steroids remain the mainstay treatment but can cause significant and permanent ocular adverse effects especially with long-term use or high doses. This body of work demonstrates Kodiak's strong protein engineering expertise to design innovative therapies, including KSI-101 (currently in Phase 1b) and KSI-102, by targeting the underlying and complex cytokine interactions underlying chronic inflammatory ocular diseases. 1. Title: Development of Anti-inflammatory Bispecific anti-TNF-α VHH anti-IL-6 Antibody Fusion for the Treatment of Inflammatory Retinal Diseases Session Title: Anti-inflammatory agents, ocular toxicity, cytokines and growth factors Presentation Date and Time: May 4, 2025; 8:00 – 9:45 AM (MT) Presentation Type: Poster Session Poster Number: 195-A0416 Elevated levels of pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) play distinct yet complementary roles in driving inflammatory retinal diseases such as non-infectious uveitis. Treatments targeting these cytokines individually may fail to control inflammation in a comprehensive manner. Here we present preclinical data of KSI-102, a novel bispecific antibody that potently inhibits both TNF-α and IL-6 simultaneously, offering enhanced therapeutic potential for inflammatory ocular diseases. 2. Title: Preserving Endothelial Barrier Function with Novel Bispecific Anti-Inflammatory Agents for the Treatment of Retinal Inflammatory Diseases Session Title: Anti-inflammatory agents, ocular toxicity, cytokines and growth factors Presentation Date and Time: May 4, 2025; 8:00 – 9:45 AM (MT) Presentation Type: Poster Session Poster Number: 196-A0417 Inflammation contributes to ocular disease by triggering a cascade of pathological events, including disruption of the blood-retinal-barrier and recruitment of immune cells to retinal tissues. These processes can lead to edema and tissue damage, which are hallmark features of conditions such as macular edema and uveitis. Adalimumab is an anti-TNF-α biologic approved as a steroid-sparing agent for the treatment of non-infectious uveitis (NIU). However, more than 50% of patients with NIU experienced treatment failure over 85 weeks in the VISUAL I trial. This preclinical presentation demonstrates that Kodiak's anti-TNF-α, anti-IL-6 fusion protein normalizes human endothelial morphology and junctional proteins better than monotherapy agents. 3. Title: Ocular Toxicity Study of KSI-101 Demonstrates Tolerability after Intravitreal Administration in Cynomolgus Monkeys Session Title: Retina/RPE: New drugs, mechanisms of action, and toxicity Presentation Date and Time: May 8, 2025; 11:45 AM – 1:30 PM (MT) Presentation Type: Poster Session Poster Number: 5998-A0183 KSI-101 is a first-in-class, local, high-strength bispecific protein in clinical development for the treatment of macular edema secondary to inflammation (MESI). Early clinical data of KSI-101 in the Phase 1b APEX study, which is enrolling patients with MESI, demonstrates that at all dose levels, KSI-101 rapidly normalizes macular edema and improves vision. To inform and support further clinical development of KSI-101, which has demonstrated a positive safety profile in patients, here we demonstrate that repeated bilateral intravitreal administration of KSI-101 in non-human primates was safe and well tolerated. The following poster was developed in collaboration with Chang Gung Memorial Hospital, Department of Ophthalmology: 4. Title: Systemic Review of Uveitic Macular Edema (UME) Outcomes in Children Versus Adults Session Title: Uveitis Epidemiology and Clinical Characterization Presentation Date and Time: May 6, 2025; 8:30-10:15 AM (MT) Presentation Type: Poster Session Poster Number: 2849-A0142 Macular edema secondary to inflammation affects adults and children, with differing underlying causes, inflammation patterns and clinical presentations. Treatment options vary by etiology, and steroids are generally avoided in children due to serious adverse effects. This study highlights the serious impact UME in particular has on vision, especially in children, and underscores the critical need for dedicated research and the development of safe and effective therapies tailored for pediatric UME. Geographic Atrophy Geographic atrophy (GA), the advanced form of dry age-related macular degeneration, affects approximately one million patients in the U.S. and is characterized by atrophic lesions in the retina that progressively expand to the central macular and fovea, leading to irreversible vision loss. Currently there are two approved therapies for GA, both are anti-complement therapies that offer modest therapeutic benefit and require monthly or every other month intravitreal injections. 5. Title: Development of Potent Bispecific Inhibitors Targeting Complement Activation and Cytokines for the Treatment of Geographic Atrophy (GA) Session Title: New drugs, delivery systems, and mechanisms of action II Presentation Date and Time: May 7, 2025; 10:15 AM – 12:00 PM (MT) Presentation Type: Poster Session Poster Number: 4337-A0493 Here we present new data on a promising therapeutic strategy to treat GA by combining complement regulators with an anti-VEGF antibody to prevent wet AMD conversion and anti-IL-6 antibody to further reduce GA progression, to achieve potent concurrent inhibition of complement pathway activation and VEGF pathway signaling. Enhancing Therapeutic Efficacy with the ABCD Platform Antibody Drug Conjugates (ADCs) and Antibody Oligonucleotide Conjugates (AOCs) are promising platforms for targeted drug delivery but have a limited drug-antibody ratio (DAR), which poses significant challenges in optimizing therapeutic efficacy. Kodiak's Antibody Biopolymer Conjugate Drug (ABCD) platform addresses this limitation by utilizing a customizable biopolymer to enable the design and development of multifunctional, high DAR therapeutics for ophthalmic and systemic applications. 6. Title: Delivery of Therapeutic Oligonucleotides by Antibody Biopolymer Conjugates (ABC®) Session Title: New drugs, delivery systems, and mechanisms of action II Presentation Date and Time: May 7, 2025; 10:15 AM – 12:00 PM (MT) Presentation Type: Poster Session Poster Number: 4334-A0490 Here we demonstrate the intracellular drug delivery capability and target knockdown potency of Antibody Biopolymer Conjugate Oligonucleotides (ABCO) in the target cells, providing a proof of concept for ABC® mediated intracellular delivery of oligonucleotide therapeutics. We demonstrate that (a) anti-TfR1 ABCO maintains high binding affinity to TfR1, (b) the antibody and its conjugates exhibit concentration dependent uptake in HepG2 cells, enabling delivery of RNA payloads, and (c) anti-TfR1 ABCOs with siRNA or ASO effectively modulate target gene expression. 7. Title: Effect of Polymer Architecture on Properties of Antibody Biopolymer Conjugates Session Title: New drugs, delivery systems, and mechanisms of action II Presentation Date and Time: May 7, 2025; 10:15 AM – 12:00 PM (MT) Presentation Type: Poster Session Poster Number: 4325-A0481 This study demonstrates how polymer architecture, specifically molar mass and number of arms in homopolymers, influences conjugate properties and explores the role of structural design. These findings guide optimization and further development of biopolymer conjugated therapeutic candidates with Kodiak's ABCD platform. About Kodiak Sciences Inc. Kodiak Sciences (Nasdaq: KOD) is a biopharmaceutical company committed to researching, developing, and commercializing transformative therapeutics to treat a broad spectrum of retinal diseases. We are focused on bringing new science to the design and manufacture of next generation retinal medicines to prevent and treat the leading causes of blindness globally. Our ABC Platform® uses molecular engineering to merge the fields of protein-based and chemistry-based therapies and has been at the core of Kodiak's discovery engine. We are developing a portfolio of three clinical programs, two of which are late-stage today and derived from our ABC Platform and one which is platform-independent and which we believe can progress rapidly into pivotal studies. Kodiak's lead investigational medicine, tarcocimab, is a novel anti-VEGF antibody biopolymer conjugate under development for the treatment of high prevalence retinal vascular diseases. Tarcocimab is currently being studied in two Phase 3 clinical trials, GLOW2 in patients with diabetic retinopathy and DAYBREAK in patients with wet AMD. GLOW2 enrollment is complete, and DAYBREAK is actively enrolling patients. KSI-501 is our second investigational medicine, a first-in-class anti-IL-6, VEGF-trap bispecific antibody biopolymer conjugate designed to inhibit both IL-6 mediated inflammation and VEGF-mediated angiogenesis and vascular permeability. KSI-501 is being developed for the treatment of high prevalence retinal vascular diseases to address the unmet needs of extended durability and targeting disease biology beyond VEGF for differentiated efficacy. The Phase 3 DAYBREAK study of KSI-501 in wet AMD is actively enrolling patients. KSI-101, our third product candidate, is a novel anti-IL-6, VEGF-trap bispecific protein. Kodiak is developing KSI-101 for the treatment of retinal inflammatory diseases, as currently there are no available intravitreal biologic therapies addressing the spectrum of inflammatory conditions of the retina. The Phase 1b APEX study of KSI-101 is actively enrolling patients, as a precursor to activating the Phase 2b/3 PEAK and PINNACLE studies in patients with macular edema secondary to inflammation ("MESI"). Kodiak is advancing its platform technology to embed small molecules and other active pharmaceutical ingredients ("APIs") into Kodiak's proprietary biopolymer backbone to enable high drug-antibody-ratio ("DAR") medicines. The diverse APIs are designed to be released over time to achieve targeted, multi-specific and tailored modulation of biological pathways. The unique combination of high DAR and tailored therapeutic benefit offers potential for broad application to multifactorial diseases and builds directly from our Antibody Biopolymer Conjugate technology and its 15 years of design, development and manufacturing experience. We call this platform extension our Antibody Biopolymer Conjugate Drug ("ABCD") Platform because we are extending our platform capabilities to include the conjugation of small molecule drugs and other APIs whereas historically, we primarily conjugated biologics such as antibodies. For more information, please visit www.kodiak.com. Kodiak®, Kodiak Sciences®, ABC®, ABC Platform®, ABCD™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions Forward-Looking Statements This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding: the power and versatility of Kodiak's ABC® platform; the enhanced therapeutic potential of KSI-102 for inflammatory ocular diseases; the potential of KSI-101 for the treatment of MESI; the potential for Kodiak's ABCD platform to enable the design and development of multifunctional, high DAR therapeutics for ophthalmic and systemic applications; and the optimization and further development of biopolymer conjugated therapeutic candidates with Kodiak's ABCD platform. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "could," "expect," "plan," "believe," "intend," "pursue," and other similar expressions among others. Any forward-looking statements are based on management's current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially and adversely from those in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that cessation, modification or delay of any of the ongoing clinical studies may occur; the risk that our research and development efforts and our ability to advance our product candidates into later stages of development may fail; the risk that any one or more of our product candidates may not be successfully developed, approved or commercialized; the risk that adverse economic conditions may significantly impact our business and operations, including our clinical trial sites, and those of our manufacturers, contract research organizations or others with whom we conduct business; the risk that sufficient capital may not be available as expected, or at all, to complete the development of any products; as well as the other risks identified in our filings with the Securities and Exchange Commission (SEC). For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our most recent Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof and Kodiak undertakes no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements. View original content:https://www.prnewswire.com/news-releases/kodiak-sciences-data-at-arvo-2025-highlight-power-and-versatility-of-abc-platform-in-addressing-complex-multifactorial-ocular-diseases-302444839.html SOURCE Kodiak Sciences Inc. John Borgeson, Chief Financial Officer, Tel (650) 281-0850, ir@kodiak.com