{"success":true,"data":{"pressRelease":{"id":"172023","rtpr_id":"nGNE52vN2B-20261019","ticker":"OCS","exchange":"NASDAQ","all_tickers":["OCS","CR5"],"title":"Oculis Completes Randomization in PREDICT-1 Registrational Trial of Licaminlimab for TNFR1-Mediated Dry Eye Disease","author":"Globe Newswire","published_at":"2026-10-19T06:00:00.113Z","article_body":"High-Responder Target Enrichment: 2/3 of the 176 enrolled patients carry the\ntarget TNFR1 genetic variant previously linked to enhanced clinical response\nin Phase 2 trials\n\nPrecision Medicine Approach in a Large Market: Licaminlimab is positioned as\na potential first-in-class precision medicine for an estimated 1.5+ million\npatients in the U.S. with moderate-to-severe TNFR1-mediated dry eye disease\n(DED)(1-4), addressing a critical unmet need in a historically heterogeneous\nindication.\n\nKey Milestone on Track: Topline data from this first-ever genotype-guided\nregistrational trial in DED are anticipated around year-end 2026\n\nZUG, Switzerland, October 19, 2026 -- Oculis Holding AG (Nasdaq: OCS / XICE:\nOCS) (Oculis), a global biopharmaceutical company focused on breakthrough\ninnovations to address significant unmet medical needs in neuro-ophthalmology\nand ophthalmology, today announced completion of randomization in the\nPREDICT-1 (Personalized dRy Eye Disease Investigational Clinical Trial)\ngenotype-based registrational trial of Licaminlimab to drive precision\nmedicine in dry eye disease (DED). Oculis expects to report topline results\naround year-end 2026.\n\nRiad Sherif, M.D., Chief Executive Officer of Oculis, said, \"Completing\nrandomization in such a timeframe with a new modality demonstrates that\ngenotype-driven development is crucial and precision medicine is urgently\nneeded in DED. PREDICT-1 is an important operational milestone as we track\ntoward topline results around year-end 2026. In prior Phase 2 studies,\nLicaminlimab showed robust improvement across both signs and symptoms of dry\neye disease, with an amplified response in patients harboring a specific TNFR1\ngenotype. Importantly, a simple, non-invasive genetic biomarker test can\nidentify this patient population, supporting the practical application of this\nprecision medicine approach. PREDICT-1 builds directly on that scientific\nrationale to validate our genotype-guided strategy. If successful,\nLicaminlimab has the potential to pioneer a first-in-class precision medicine\ntreatment paradigm, delivering targeted relief to a large, underserved patient\npopulation with TNFR1-driven disease.(”)\n\nAnat Galor, M.D., M.S.P.H., Professor of Ophthalmology, Bascom Palmer Eye\nInstitute, Miami, added: \"Dry eye disease is a highly heterogeneous\ncondition, and treatment response can vary considerably between patients. As a\nresult, selecting the right therapy often involves a lengthy trial-and-error\nprocess that can lead to patient dissatisfaction and early treatment\ndiscontinuation. A precision medicine approach to identify individuals more\nlikely to benefit from a specific therapy could meaningfully advance care for\nboth patients and clinicians. The findings observed in earlier studies of\nLicaminlimab provide a compelling rationale for the PREDICT-1 trial, and I\nlook forward to seeing whether this targeted approach can advance a more\neffective treatment paradigm and improve outcomes for patients living with dry\neye disease.\"\n\nPREDICT‑1, the program's first registrational trial, is designed to evaluate\nthe efficacy of Licaminlimab in DED symptoms compared with vehicle in patients\ncarrying a specific TNFR1 genotype, while also assess its effect and safety in\nthe overall study population. Randomization is complete, with 176 patients\nenrolled in this randomized, multicenter, double-masked, vehicle-controlled\nstudy, 2/3 of whom have the specified TNFR1 genotype. The primary endpoint is\nthe change from baseline at Day 29 in the global ocular discomfort severity\nscore in patients with the specified TNFR1 genotype. The same outcome measure\nwill be evaluated in the overall study population as a key secondary endpoint.\nOculis expects to report topline results around year-end 2026.\n\nIn a prior Phase 2 trial evaluating DED symptoms, patients treated with\nLicaminlimab experienced a statistically significant reduction in ocular\ndiscomfort compared with vehicle at Day 29, with a rapid onset of action\nobserved as early as Day 14.(5)\n\nTNFR1 is a receptor that mediates TNFα-driven inflammation and apoptosis. In\nphase 2 trials, Licaminlimab has shown greater clinical response, with\nsubstantial improvements in signs and symptoms, among patients with a specific\nTNFR1 genotype. These findings are consistent with the literature suggesting\nthat genetic variation in the TNF/TNFR1 pathway may account for variability in\nthe inflammatory response(6), and that TNFR1-mediated inflammation may play a\nkey role in ocular surface pathology in DED. A simple biomarker test could\nidentify the relevant genetic variant, potentially helping physicians\ndetermine which patients are more likely to benefit from treatment. The\nPREDICT-1 trial is designed to leverage these findings with the aim to deliver\nprecision medicine to patients with TNFR1-mediated DED.\n\nAn estimated 40 million people in the U.S. have DED and about half are\nformally diagnosed.(1) Among them, approximately 10 million have\nmoderate-to-severe disease requiring active treatment.\".(1)(-2) Current\ndisease management relies heavily on a trial-and-error therapeutic approach,\nwith only ~13% of patients achieving sustained relief(7), driving an 85–90%\ndiscontinuation rate within the first six months(8) and underscoring the\nurgent need for targeted, effective therapy. Approximately 13% to 19% of\npatients with moderate-to-severe DED, representing an estimated 1.3 to 1.9\nmillion individuals, carry the relevant TNFR1 genetic variant and could\npotentially benefit from Licaminlimab.(1-4 )If approved, Licaminlimab has the\npotential to transform the treatment landscape by shifting from today’s\ntrial-and-error approach to the first precision medicine for TNFR1-mediated\nDED.\n\n- Ends -\n\nAbout Licaminlimab\n\nLicaminlimab is an anti-TNFα eye drop candidate being developed with a single\nchain antibody fragment (scFv) technology specifically developed to treat\nocular inflammatory diseases. The dual anti-inflammatory and anti-necrotic\nmechanism of action of TNF-α inhibition has been well-established in\ninflammatory disorders where the systemic use of TNF-α inhibitors has led to\nmarked improvements in the disease management and treatment outcomes. In Phase\n2 trials, Licaminlimab has shown a positive treatment effect on both the signs\nand symptoms of DED and has been well tolerated. In addition, a genetic\nbiomarker has been identified which showed a more pronounced treatment effect\nwith Licaminlimab in patients with a specific TNFR1 genotype. If approved,\nLicaminlimab has the potential to transform the treatment paradigm with a\nprecision medicine approach.\n\nLicaminlimab is an investigational drug in registrational trial and has not\nreceived regulatory approval for commercial use in any country.\n\nAbout Dry Eye Disease (DED)\n\nDED is a multifactorial disease in which ocular surface inflammation plays a\ncentral role in sustaining the pathological state(9)(,10). It usually affects\nboth eyes and patients may experience a stinging, burning or scratchy\nsensation. In addition, some patients experience sensitivity to light, eye\nredness, difficulty wearing contact lenses, difficulty with nighttime driving,\nand blurred vision which can greatly affect their quality of life.\n\nIt is a common condition estimated to impact more than 110 million people in\nthe G7 countries (U.S., U.K., Germany, France, Spain, Italy, Japan).(1) Of\nthe approximately 20 million patients who are diagnosed with DED in the U.S.,\nabout half or 10 million are considered to have moderate to severe\ndisease.(1)(,2) However, only 13% of DED patients receive prescription\ntreatment, primarily with anti-inflammatory medications(1) and despite\navailable therapies, most patients (87%) don’t feel that their chronic DED\nis well-managed(7) which highlights a high level of dissatisfaction.\nFurthermore, 90% of patients discontinued their treatment altogether within\none year with the vast majority discontinuing in the first 6 months.(8) Unmet\nmedical needs remain for novel anti-inflammatory treatments which are\nefficacious, fast-acting and well-tolerated as well as developing targeted\ntherapeutics for specific patient subtypes to improve treatment outcomes for\nthis heterogeneous patient population.\n\nAbout Oculis\n\nOculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused\non breakthrough innovations to address significant unmet medical needs in\nneuro-ophthalmology and ophthalmology. Oculis’ highly differentiated\nlate-stage clinical pipeline focuses on two core product candidates.\nPrivosegtor is a breakthrough neuroprotective candidate in the PIONEER\nprogram, which consists of studies intended to support registration plans for\ntreatment of optic neuropathies, including optic neuritis (ON) and\nnon-arteritic anterior ischemic optic neuropathy (NAION). Privosegtor also has\npotential to be developed for additional indications in other neuro-ophthalmic\nand neuro-axonal diseases. Licaminlimab is a novel, topical anti-TNFα in a\nregistrational trial, and is being developed with a genotype-based approach\nfor treating patients with dry eye disease (DED). Headquartered in Switzerland\nwith operations in the U.S., Iceland and Switzerland, Oculis is led by an\nexperienced management team with a successful track record and supported by\nleading international healthcare investors.\n\nFor more information, please visit: www.oculis.com\n\nOculis Contact\nMs. Sylvia Cheung, CFO\nsylvia.cheung@oculis.com\n\nInvestor Relations \nLifeSci Advisors\nCorey Davis, Ph.D.\ncdavis@lifesciadvisors.com\n\nMedia Relations\nICR Healthcare\nAmber Fennell \noculis@icrhealthcare.com\n\nCautionary Statement Regarding Forward Looking Statements\n\nThis press release contains forward-looking statements and information. For\nexample, statements regarding the potential benefits of the Company’s\nproduct candidates, including the potential of Licaminlimab to redefine the\ntreatment paradigm in dry eye disease with a precision medicine approach and\nsatisfy an unmet medical need; the initiation, timing, progress and results of\ncurrent and future clinical trials, including the progress and timing of the\nPREDICT-1 trial of Licaminlimab and timing of topline results; Oculis’\nresearch and development programs, regulatory and business strategy; expected\nmilestones; and statements about market opportunity and the estimated number\nof DED patients with the specific TNFR1 genotype, are forward-looking. All\nforward-looking statements are based on estimates and assumptions that, while\nconsidered reasonable by Oculis and its management, are inherently uncertain\nand are inherently subject to risks, variability, and contingencies, many of\nwhich are beyond Oculis’ control. Results from prior clinical trials may not\nbe replicated in later clinical trials. These forward-looking statements are\nprovided for illustrative purposes only and are not intended to serve as, and\nmust not be relied on by an investor as, a guarantee, assurance, prediction or\ndefinitive statement of a fact or probability. Actual events and circumstances\nare difficult or impossible to predict and will differ from assumptions. All\nforward-looking statements are subject to risks, uncertainties and other\nfactors that may cause actual results to differ materially from those that we\nexpected and/or those expressed or implied by such forward-looking statements.\nForward-looking statements are subject to numerous conditions, many of which\nare beyond the control of Oculis, including those set forth in the Risk\nFactors exhibit to Oculis’ Form 6-K filed on August 6, 2026 and any other\ndocuments filed with the SEC. Copies of these documents are available on the\nSEC’s website, www.sec.gov. Oculis undertakes no obligation to update these\nstatements for revisions or changes after the date of this release, except as\nrequired by law.\n\nReferences:\n\n      (1)   Jain H, et al. (2020): Dry eye disease landscape and\nforecast. Decision Resources Group (DRG). Prevalence for G7 countries:\nFrance, Germany, Italy, Japan, Spain, UK, and US.\n      (2)   GlobalData – Dry Eye Syndrome Global Drug Forecast and\nMarket Analysis to 2026\n      (3)   Galor, A., et al. Licaminlimab in the treatment of dry\neye disease: Results from Phase 2 evaluations. Association for Research in\nVision and Ophthalmology (ARVO) Annual Meeting.\n\n      (4)   Acuna, Kelly & al. (2023). Impact of Tumor Necrosis\nFactor Receptor 1 (TNFR1) Polymorphism on Dry Eye Disease. Biomolecules.\n      (5)   Shettle L, et al. Topical Anti-TNFα Agent Licaminlimab\n(OCS-02) Relieves Persistent Ocular Discomfort in Severe Dry Eye Disease: A\nRandomized Phase II Study. Clin Ophthalmol. 2022 \n      (6)   Curry P. et al. (2022) Do genetics contribute to TNF\ninhibition response prediction in Psoriatic Arthritis? The Pharmacogenomics\nJournal.\n      (7)   Mukamal, R. Why is Dry Eye So Difficult to Treat?\n2021 https://www.aao.org/eye-health/tips-prevention/fix-dry-eye-treatment-eyedrops\n      (8)   Mbagwu M. et al.: Characterization of Discontinuation and\nSwitching Patterns of DED Medications Using Linked HER Registry and Claims\nData. Presented at ASCRS Annual Meeting 2024.\n\n      (9)   TFOS DEWS II The Ocular Surface 15 (2017)\n      (10)   Baudouin C. Dry Eye Disease, the complex interactions of\nvicious cycles. EuDES European Dry Eye\nSociety https://www.dryeye-society.com/resources/dry-eye-disease-complex-interactions-vicious-cycles","article_body_html":"","raw_payload":{"data":{"id":"nGNE52vN2B-20261019","title":"Oculis Completes Randomization in PREDICT-1 Registrational Trial of Licaminlimab for TNFR1-Mediated Dry Eye Disease","author":"Globe Newswire","ticker":"OCS","created":"2026-10-19T06:00:00.113Z","tickers":["OCS","CR5"],"exchange":"NASDAQ","article_body":"High-Responder Target Enrichment: 2/3 of the 176 enrolled patients carry the\ntarget TNFR1 genetic variant previously linked to enhanced clinical response\nin Phase 2 trials\n\nPrecision Medicine Approach in a Large Market: Licaminlimab is positioned as\na potential first-in-class precision medicine for an estimated 1.5+ million\npatients in the U.S. with moderate-to-severe TNFR1-mediated dry eye disease\n(DED)(1-4), addressing a critical unmet need in a historically heterogeneous\nindication.\n\nKey Milestone on Track: Topline data from this first-ever genotype-guided\nregistrational trial in DED are anticipated around year-end 2026\n\nZUG, Switzerland, October 19, 2026 -- Oculis Holding AG (Nasdaq: OCS / XICE:\nOCS) (Oculis), a global biopharmaceutical company focused on breakthrough\ninnovations to address significant unmet medical needs in neuro-ophthalmology\nand ophthalmology, today announced completion of randomization in the\nPREDICT-1 (Personalized dRy Eye Disease Investigational Clinical Trial)\ngenotype-based registrational trial of Licaminlimab to drive precision\nmedicine in dry eye disease (DED). Oculis expects to report topline results\naround year-end 2026.\n\nRiad Sherif, M.D., Chief Executive Officer of Oculis, said, \"Completing\nrandomization in such a timeframe with a new modality demonstrates that\ngenotype-driven development is crucial and precision medicine is urgently\nneeded in DED. PREDICT-1 is an important operational milestone as we track\ntoward topline results around year-end 2026. In prior Phase 2 studies,\nLicaminlimab showed robust improvement across both signs and symptoms of dry\neye disease, with an amplified response in patients harboring a specific TNFR1\ngenotype. Importantly, a simple, non-invasive genetic biomarker test can\nidentify this patient population, supporting the practical application of this\nprecision medicine approach. PREDICT-1 builds directly on that scientific\nrationale to validate our genotype-guided strategy. If successful,\nLicaminlimab has the potential to pioneer a first-in-class precision medicine\ntreatment paradigm, delivering targeted relief to a large, underserved patient\npopulation with TNFR1-driven disease.(”)\n\nAnat Galor, M.D., M.S.P.H., Professor of Ophthalmology, Bascom Palmer Eye\nInstitute, Miami, added: \"Dry eye disease is a highly heterogeneous\ncondition, and treatment response can vary considerably between patients. As a\nresult, selecting the right therapy often involves a lengthy trial-and-error\nprocess that can lead to patient dissatisfaction and early treatment\ndiscontinuation. A precision medicine approach to identify individuals more\nlikely to benefit from a specific therapy could meaningfully advance care for\nboth patients and clinicians. The findings observed in earlier studies of\nLicaminlimab provide a compelling rationale for the PREDICT-1 trial, and I\nlook forward to seeing whether this targeted approach can advance a more\neffective treatment paradigm and improve outcomes for patients living with dry\neye disease.\"\n\nPREDICT‑1, the program's first registrational trial, is designed to evaluate\nthe efficacy of Licaminlimab in DED symptoms compared with vehicle in patients\ncarrying a specific TNFR1 genotype, while also assess its effect and safety in\nthe overall study population. Randomization is complete, with 176 patients\nenrolled in this randomized, multicenter, double-masked, vehicle-controlled\nstudy, 2/3 of whom have the specified TNFR1 genotype. The primary endpoint is\nthe change from baseline at Day 29 in the global ocular discomfort severity\nscore in patients with the specified TNFR1 genotype. The same outcome measure\nwill be evaluated in the overall study population as a key secondary endpoint.\nOculis expects to report topline results around year-end 2026.\n\nIn a prior Phase 2 trial evaluating DED symptoms, patients treated with\nLicaminlimab experienced a statistically significant reduction in ocular\ndiscomfort compared with vehicle at Day 29, with a rapid onset of action\nobserved as early as Day 14.(5)\n\nTNFR1 is a receptor that mediates TNFα-driven inflammation and apoptosis. In\nphase 2 trials, Licaminlimab has shown greater clinical response, with\nsubstantial improvements in signs and symptoms, among patients with a specific\nTNFR1 genotype. These findings are consistent with the literature suggesting\nthat genetic variation in the TNF/TNFR1 pathway may account for variability in\nthe inflammatory response(6), and that TNFR1-mediated inflammation may play a\nkey role in ocular surface pathology in DED. A simple biomarker test could\nidentify the relevant genetic variant, potentially helping physicians\ndetermine which patients are more likely to benefit from treatment. The\nPREDICT-1 trial is designed to leverage these findings with the aim to deliver\nprecision medicine to patients with TNFR1-mediated DED.\n\nAn estimated 40 million people in the U.S. have DED and about half are\nformally diagnosed.(1) Among them, approximately 10 million have\nmoderate-to-severe disease requiring active treatment.\".(1)(-2) Current\ndisease management relies heavily on a trial-and-error therapeutic approach,\nwith only ~13% of patients achieving sustained relief(7), driving an 85–90%\ndiscontinuation rate within the first six months(8) and underscoring the\nurgent need for targeted, effective therapy. Approximately 13% to 19% of\npatients with moderate-to-severe DED, representing an estimated 1.3 to 1.9\nmillion individuals, carry the relevant TNFR1 genetic variant and could\npotentially benefit from Licaminlimab.(1-4 )If approved, Licaminlimab has the\npotential to transform the treatment landscape by shifting from today’s\ntrial-and-error approach to the first precision medicine for TNFR1-mediated\nDED.\n\n- Ends -\n\nAbout Licaminlimab\n\nLicaminlimab is an anti-TNFα eye drop candidate being developed with a single\nchain antibody fragment (scFv) technology specifically developed to treat\nocular inflammatory diseases. The dual anti-inflammatory and anti-necrotic\nmechanism of action of TNF-α inhibition has been well-established in\ninflammatory disorders where the systemic use of TNF-α inhibitors has led to\nmarked improvements in the disease management and treatment outcomes. In Phase\n2 trials, Licaminlimab has shown a positive treatment effect on both the signs\nand symptoms of DED and has been well tolerated. In addition, a genetic\nbiomarker has been identified which showed a more pronounced treatment effect\nwith Licaminlimab in patients with a specific TNFR1 genotype. If approved,\nLicaminlimab has the potential to transform the treatment paradigm with a\nprecision medicine approach.\n\nLicaminlimab is an investigational drug in registrational trial and has not\nreceived regulatory approval for commercial use in any country.\n\nAbout Dry Eye Disease (DED)\n\nDED is a multifactorial disease in which ocular surface inflammation plays a\ncentral role in sustaining the pathological state(9)(,10). It usually affects\nboth eyes and patients may experience a stinging, burning or scratchy\nsensation. In addition, some patients experience sensitivity to light, eye\nredness, difficulty wearing contact lenses, difficulty with nighttime driving,\nand blurred vision which can greatly affect their quality of life.\n\nIt is a common condition estimated to impact more than 110 million people in\nthe G7 countries (U.S., U.K., Germany, France, Spain, Italy, Japan).(1) Of\nthe approximately 20 million patients who are diagnosed with DED in the U.S.,\nabout half or 10 million are considered to have moderate to severe\ndisease.(1)(,2) However, only 13% of DED patients receive prescription\ntreatment, primarily with anti-inflammatory medications(1) and despite\navailable therapies, most patients (87%) don’t feel that their chronic DED\nis well-managed(7) which highlights a high level of dissatisfaction.\nFurthermore, 90% of patients discontinued their treatment altogether within\none year with the vast majority discontinuing in the first 6 months.(8) Unmet\nmedical needs remain for novel anti-inflammatory treatments which are\nefficacious, fast-acting and well-tolerated as well as developing targeted\ntherapeutics for specific patient subtypes to improve treatment outcomes for\nthis heterogeneous patient population.\n\nAbout Oculis\n\nOculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused\non breakthrough innovations to address significant unmet medical needs in\nneuro-ophthalmology and ophthalmology. Oculis’ highly differentiated\nlate-stage clinical pipeline focuses on two core product candidates.\nPrivosegtor is a breakthrough neuroprotective candidate in the PIONEER\nprogram, which consists of studies intended to support registration plans for\ntreatment of optic neuropathies, including optic neuritis (ON) and\nnon-arteritic anterior ischemic optic neuropathy (NAION). Privosegtor also has\npotential to be developed for additional indications in other neuro-ophthalmic\nand neuro-axonal diseases. Licaminlimab is a novel, topical anti-TNFα in a\nregistrational trial, and is being developed with a genotype-based approach\nfor treating patients with dry eye disease (DED). Headquartered in Switzerland\nwith operations in the U.S., Iceland and Switzerland, Oculis is led by an\nexperienced management team with a successful track record and supported by\nleading international healthcare investors.\n\nFor more information, please visit: www.oculis.com\n\nOculis Contact\nMs. Sylvia Cheung, CFO\nsylvia.cheung@oculis.com\n\nInvestor Relations \nLifeSci Advisors\nCorey Davis, Ph.D.\ncdavis@lifesciadvisors.com\n\nMedia Relations\nICR Healthcare\nAmber Fennell \noculis@icrhealthcare.com\n\nCautionary Statement Regarding Forward Looking Statements\n\nThis press release contains forward-looking statements and information. For\nexample, statements regarding the potential benefits of the Company’s\nproduct candidates, including the potential of Licaminlimab to redefine the\ntreatment paradigm in dry eye disease with a precision medicine approach and\nsatisfy an unmet medical need; the initiation, timing, progress and results of\ncurrent and future clinical trials, including the progress and timing of the\nPREDICT-1 trial of Licaminlimab and timing of topline results; Oculis’\nresearch and development programs, regulatory and business strategy; expected\nmilestones; and statements about market opportunity and the estimated number\nof DED patients with the specific TNFR1 genotype, are forward-looking. All\nforward-looking statements are based on estimates and assumptions that, while\nconsidered reasonable by Oculis and its management, are inherently uncertain\nand are inherently subject to risks, variability, and contingencies, many of\nwhich are beyond Oculis’ control. Results from prior clinical trials may not\nbe replicated in later clinical trials. These forward-looking statements are\nprovided for illustrative purposes only and are not intended to serve as, and\nmust not be relied on by an investor as, a guarantee, assurance, prediction or\ndefinitive statement of a fact or probability. Actual events and circumstances\nare difficult or impossible to predict and will differ from assumptions. All\nforward-looking statements are subject to risks, uncertainties and other\nfactors that may cause actual results to differ materially from those that we\nexpected and/or those expressed or implied by such forward-looking statements.\nForward-looking statements are subject to numerous conditions, many of which\nare beyond the control of Oculis, including those set forth in the Risk\nFactors exhibit to Oculis’ Form 6-K filed on August 6, 2026 and any other\ndocuments filed with the SEC. Copies of these documents are available on the\nSEC’s website, www.sec.gov. Oculis undertakes no obligation to update these\nstatements for revisions or changes after the date of this release, except as\nrequired by law.\n\nReferences:\n\n      (1)   Jain H, et al. (2020): Dry eye disease landscape and\nforecast. Decision Resources Group (DRG). Prevalence for G7 countries:\nFrance, Germany, Italy, Japan, Spain, UK, and US.\n      (2)   GlobalData – Dry Eye Syndrome Global Drug Forecast and\nMarket Analysis to 2026\n      (3)   Galor, A., et al. Licaminlimab in the treatment of dry\neye disease: Results from Phase 2 evaluations. Association for Research in\nVision and Ophthalmology (ARVO) Annual Meeting.\n\n      (4)   Acuna, Kelly & al. (2023). Impact of Tumor Necrosis\nFactor Receptor 1 (TNFR1) Polymorphism on Dry Eye Disease. Biomolecules.\n      (5)   Shettle L, et al. Topical Anti-TNFα Agent Licaminlimab\n(OCS-02) Relieves Persistent Ocular Discomfort in Severe Dry Eye Disease: A\nRandomized Phase II Study. Clin Ophthalmol. 2022 \n      (6)   Curry P. et al. (2022) Do genetics contribute to TNF\ninhibition response prediction in Psoriatic Arthritis? The Pharmacogenomics\nJournal.\n      (7)   Mukamal, R. Why is Dry Eye So Difficult to Treat?\n2021 https://www.aao.org/eye-health/tips-prevention/fix-dry-eye-treatment-eyedrops\n      (8)   Mbagwu M. et al.: Characterization of Discontinuation and\nSwitching Patterns of DED Medications Using Linked HER Registry and Claims\nData. Presented at ASCRS Annual Meeting 2024.\n\n      (9)   TFOS DEWS II The Ocular Surface 15 (2017)\n      (10)   Baudouin C. Dry Eye Disease, the complex interactions of\nvicious cycles. EuDES European Dry Eye\nSociety https://www.dryeye-society.com/resources/dry-eye-disease-complex-interactions-vicious-cycles"},"type":"article","timestamp":"2026-10-19T06:00:00.227245854Z","server_sent_at_ms":1792389600227},"received_at":"2026-10-19T06:00:00.522Z","source_url":null},"analysis":{"id":"160170","press_release_id":"172023","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["No efficacy data yet — Phase 2 results may not replicate in the registrational trial","Primary endpoint is limited to the TNFR1 genotype subgroup (~2/3 of enrollees), adding enrichment risk"],"eventType":"clinical_trial","narrative":"Oculis completed randomization of 176 patients in PREDICT-1, its genotype-based registrational trial of Licaminlimab for TNFR1-mediated dry eye disease.\n\nTwo-thirds of enrolled patients carry the target TNFR1 genetic variant previously linked to enhanced response in Phase 2, and topline data are expected around year-end 2026.\n\nIf successful, Licaminlimab would be a first-in-class precision medicine for an estimated 1.5+ million U.S. patients with moderate-to-severe TNFR1-mediated DED; the result remains a binary clinical readout.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"PREDICT-1 on track with ~176-patient randomization complete; set alerts for topline data around year-end 2026."},"keyFigures":{"drugName":"Licaminlimab","phaseOfTrial":"registrational (Phase 3-equivalent, PREDICT-1)","customDimensions":{"patients_enrolled":176,"topline_data_timing":"around year-end 2026","tnfr1_genotype_share":"2/3 of enrolled patients","addressable_patients_us":"1.3-1.9 million (1.5+ million estimated)"}},"quotedText":"Completing randomization in such a timeframe with a new modality demonstrates that genotype-driven development is crucial and precision medicine is urgently needed in DED.","namedEntities":{"people":[{"name":"Riad Sherif, M.D.","role":"CEO of Oculis"},{"name":"Anat Galor, M.D., M.S.P.H.","role":"Professor of Ophthalmology, Bascom Palmer Eye Institute"},{"name":"Sylvia Cheung","role":"CFO of Oculis"}],"products":["Licaminlimab","Privosegtor"],"companies":[{"name":"Oculis Holding AG","ticker":"OCS","relationship":"filer"},{"name":"LifeSci Advisors","relationship":"investor relations"},{"name":"ICR Healthcare","relationship":"media relations"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Completion of randomization is an operational milestone, not data; the binary event (topline results) is still weeks away around year-end 2026. It confirms the registrational trial remains on track."},"tickerRelevance":{"others":[],"primary":"OCS"},"globalImportance":25,"audienceRelevance":25,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-cap biotech","eventGravity":"operational trial milestone, no data","binaryUpcoming":"topline PREDICT-1 readout year-end 2026"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":2,"narrative":"Oculis completed randomization of 176 patients in PREDICT-1, its genotype-based registrational trial of Licaminlimab for TNFR1-mediated dry eye disease.\n\nTwo-thirds of enrolled patients carry the target TNFR1 genetic variant previously linked to enhanced response in Phase 2, and topline data are expected around year-end 2026.\n\nIf successful, Licaminlimab would be a first-in-class precision medicine for an estimated 1.5+ million U.S. patients with moderate-to-severe TNFR1-mediated DED; the result remains a binary clinical readout.","key_figures":{"drugName":"Licaminlimab","phaseOfTrial":"registrational (Phase 3-equivalent, PREDICT-1)","customDimensions":{"patients_enrolled":176,"topline_data_timing":"around year-end 2026","tnfr1_genotype_share":"2/3 of enrolled patients","addressable_patients_us":"1.3-1.9 million (1.5+ million estimated)"}},"named_entities":{"people":[{"name":"Riad Sherif, M.D.","role":"CEO of Oculis"},{"name":"Anat Galor, M.D., M.S.P.H.","role":"Professor of Ophthalmology, Bascom Palmer Eye Institute"},{"name":"Sylvia Cheung","role":"CFO of Oculis"}],"products":["Licaminlimab","Privosegtor"],"companies":[{"name":"Oculis Holding AG","ticker":"OCS","relationship":"filer"},{"name":"LifeSci Advisors","relationship":"investor relations"},{"name":"ICR Healthcare","relationship":"media relations"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-19T06:00:06.879Z","global_importance":25,"audience_relevance":25,"importance_components":{"tickerTier":"small-cap biotech","eventGravity":"operational trial milestone, no data","binaryUpcoming":"topline PREDICT-1 readout year-end 2026"}},"durationMs":6306,"modelName":"glm-5.3-flashx"}}