Oculis Announces Presentation of Phase 2 ACUITY trial results with Privosegtor in Acute Optic Neuritis at ECTRIMS
Oculis (NASDAQ: OCS) announced upcoming presentation of positive Phase 2 ACUITY trial results for Privosegtor (OCS-05) in acute optic neuritis at ECTRIMS 2025 Congress. The trial demonstrated clinically meaningful improvements in vision with 18 letters at 3 months, preservation of retinal structure, and a favorable safety profile.
The presentation, scheduled for September 24, 2025, will be delivered by Dr. Céline Louapre from Pitié-Salpêtrière Hospital. The study showed promising neuroprotective effects, including preservation of retinal ganglion cells and significant improvements in low contrast visual acuity, highlighting potential applications in multiple sclerosis relapses and other neuro-ophthalmic conditions.
Oculis (NASDAQ: OCS) ha annunciato la prossima presentazione dei positivi risultati della fase 2 ACUITY su Privosegtor (OCS-05) per neurite ottica acuta al Congresso ECTRIMS 2025. Lo studio ha mostrato miglioramenti clinicamente significativi della vista con 18 lettere a 3 mesi, conservazione della struttura retinica e un profilo di sicurezza favorevole. La presentazione, prevista per il 24 settembre 2025, sarà tenuta dalla Dottaressa Céline Louapre dell'Hôpital Pitié-Salpêtrière. Lo studio ha mostrato effetti neuroprotettivi promettenti, inclusa la conservazione delle cellule ganglionari della retina e significativi miglioramenti dell'acuità visiva a basso contrasto, evidenziando potenziali applicazioni nelle ricadute di sclerosi multipla e altre condizioni neuro-oftalmiche.
Oculis (NASDAQ: OCS) anunció la próxima presentación de resultados positivos de la fase 2 ACUITY para Privosegtor (OCS-05) en neuritis óptica aguda en el Congreso ECTRIMS 2025. El ensayo mostró mejoras clínicamente significativas en la visión con 18 letras a los 3 meses, preservación de la estructura retiniana y un perfil de seguridad favorable. La presentación, programada para el 24 de septiembre de 2025, será dirigida por la Dra. Céline Louapre del Hospital Pitié-Salpêtrière. El estudio mostró efectos neuroprotectores prometedores, incluida la preservación de las células ganglionares de la retina y mejoras significativas en la agudeza visual de bajo contraste, destacando posibles aplicaciones en recaídas de esclerosis múltiple y otras condiciones neuro-oftalmológicas.
Oculis(NASDAQ: OCS)는 ECTRIMS 2025 학회에서 급성 시신경염에 대한 Privosegtor(OCS-05)의 2상 ACUITY 시험 결과의 긍정적 발표를 곧 발표한다고 밝혔다. 이 시험은 3개월 시점에서 18글자에 달하는 시력의 임상적으로 의미 있는 개선, 망막 구조의 보존, 그리고 우수한 안전성 프로파일을 보여주었다. 발표는 2025년 9월 24일로 예정되어 있으며 파리에 위치한 Pitié-Salpêtrière 병원의 D. Céline Louapre 박사가 발표를 맡는다. 연구는 망막 신경절 세포의 보존과 저 대비 시력의 유의미한 개선 등 유망한 신경보호 효과를 보여주었으며, 다발성 경화증 재발 및 기타 신경-안구 질환에서의 잠재적 적용 가능성을 강조한다.
Oculis (NASDAQ: OCS) a annoncé la présentation prochaine des résultats positifs de l'essai de phase 2 ACUITY pour Privosegtor (OCS-05) dans la névrite optique aiguë au congrès ECTRIMS 2025. L'essai a démontré des améliorations cliniquement significatives de la vision avec 18 lettres à 3 mois, la préservation de la structure rétinienne et un profil de sécurité favorable. La présentation, prévue le 24 septembre 2025, sera présentée par le Dr Céline Louapre de l'hôpital Pitié-Salpêtrière. L'étude a montré des effets neuroprotecteurs prometteurs, y compris la préservation des cellules ganglionnaires de la rétine et des améliorations significatives de l'acuité visuelle à faible contraste, mettant en évidence des applications potentielles dans les rechutes de sclérose en plaques et d'autres conditions neuro-ophthalmologiques.
Oculis (NASDAQ: OCS) kündigte die bevorstehende Präsentation positiver Ergebnisse der Phase-2-ACUITY-Studie zu Privosegtor (OCS-05) bei der akuten Optikusneuritis auf dem ECTRIMS 2025 Kongress an. Die Studie zeigte klinisch bedeutsame Verbesserungen des Sehvermögens mit 18 Buchstaben nach 3 Monaten, Erhalt der retinalen Struktur und ein günstiges Sicherheitsprofil. Die Präsentation am 24. September 2025 wird von Dr. Céline Louapre vom Hôpital Pitié-Salpêtrière gehalten. Die Studie zeigte vielversprechende neuroprotektive Effekte, einschließlich Erhaltung der retinalen Ganglienzellen und signifikante Verbesserungen der Sehkraft bei geringem Kontrast, und hebt potenzielle Anwendungen bei schubförmiger Multipler Sklerose und anderen neuro-ophthalmologischen Erkrankungen hervor.
أعلنت شركة Oculis (NASDAQ: OCS) عن عرض قريب لنتائج إيجابية من تجربة المرحلة الثانية ACUITY لـ Privosegtor (OCS-05) في التهاب العصب البصري الحاد في مؤتمر ECTRIMS 2025. أظهرت التجربة تحسينات سريرية ذات معنى في الرؤية بمقدار 18 حرفاً عند ثلاثة أشهر، وحفظ بنية الشبكية، وملف أمان مفضل. من المقرر أن تُقدَّم العرض في 24 سبتمبر 2025 من قبل الدكتورة سيليـن لواپِر من مستشفى بيت-سالبترير. أظهرت الدراسة آثاراً وقائية عصبية واعدة، بما في ذلك حفظ خلايا العقدة الشبكية وتحسينات كبيرة في حدة الرؤية منخفضة التباين، مع إبراز التطبيقات المحتملة في نوبات التفاقم لمرض التصلب المتعدد وغيرها من الحالات العصبية-العيونية.
Oculis（纳斯达克：OCS）宣布将在 ECTRIMS 2025 大会 上公布 Privosegtor（OCS-05）在急性视神经炎的 2 期 ACUITY 试验 的积极结果。该试验在 3 个月时实现了视力的临床显著改善，提升 18 字母、保留视网膜结构，并具有良好的安全性。此次演讲定于 2025 年 9 月 24 日，由巴黎圣日耳曼医院的 Céline Louapre 博士主讲。研究显示出有前景的神经保护效果，包括保留视网膜神经节细胞，以及在低对比敏感度方面的显著改善，强调在多发性硬化症复发及其他神经眼科疾病中的潜在应用。
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Insights
Oculis' Phase 2 trial shows Privosegtor improved vision and preserved retinal structure in optic neuritis patients—potentially expanding into MS treatment.
The Phase 2 ACUITY trial results for Privosegtor (OCS-05) demonstrate significant therapeutic potential in acute optic neuritis (AON). The study achieved clinically meaningful improvements in low contrast visual acuity with an impressive 18 letter improvement at 3 months, alongside preservation of retinal structure. These dual benefits address both functional and structural aspects of the disease.
The trial's preservation of retinal ganglion cells is particularly notable as these neurons are crucial for transmitting visual information from the eye to the brain. Their loss in AON leads to permanent vision impairment, making neuroprotective strategies highly valuable. The favorable safety profile further enhances Privosegtor's clinical potential.
AON serves as an excellent clinical model for testing neuroprotective agents because it allows direct assessment of structural preservation through imaging and functional improvements through vision testing. The positive results in this well-established model strongly suggest Privosegtor's neuroprotective mechanism could extend beyond optic neuritis.
The company's strategic plans to expand into multiple sclerosis (MS) relapse treatment represents a logical progression. AON frequently occurs as the initial presentation or a relapse of MS, with approximately 20% of MS patients experiencing it during their disease course. Current MS relapse treatments focus primarily on reducing inflammation rather than protecting neurons, highlighting the significant unmet need Privosegtor could address.
Privosegtor ACUITY Trial showed Improved LCVA and preservation of Ganglion Cells in Acute Optic Neuritis. Results from a Multicenter Randomized Placebo-Controlled Double-Masked Trial
ZUG, Switzerland, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis”), a global biopharmaceutical company focused on innovations for ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs, today announced the upcoming presentation of the positive Phase 2 ACUITY trial results investigating Privosegtor (OCS-05) in acute optic neuritis at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2025 Congress.
Details of Oculis’ presentation:
ECTRIMS 2025:
- Reduction in Retinal Ganglion Cell Loss and Improved Low Contrast Visual Acuity with Privosegtor in Acute Optic Neuritis: Results from a Multicenter Randomized Placebo-Controlled Double-Masked Trial.
Presenter: Céline Louapre, M.D., Ph.D., Pitié-Salpêtrière Hospital
Session: Late Breaking Abstracts
Date/Time: Wednesday, September 24, 2025; 08:30 CET
Riad Sherif, M.D., Chief Executive Officer of Oculis, commented: “It is a privilege to collaborate with Pitié-Salpêtrière Hospital, a world-renowned center for modern neurology, on the Phase 2 ACUITY trial investigating Privosegtor (OCS-05) in patients with acute optic neuritis, a well-established clinical model for neuroprotection. Topline results showed clinically meaningful improvements in vision with 18 letters at 3 months, along with the preservation of retinal structure and a favorable safety profile, highlighting Privosegtor’s potential broad applicability in various neuro-ophthalmic and neurological diseases. We look forward to sharing these significant results with the multiple sclerosis community as we continue to advance this candidate into further studies in optic neuritis and beyond, including a new program to be initiated for the treatment of MS relapses.”
Céline Louapre, M.D., Ph.D., added: “It is an honor to present these positive results at ECTRIMS, the largest MS congress in the world. In this study, Privosegtor (OCS-05) demonstrated promising neuroprotective effects, including the preservation of retinal ganglion cells, and was also associated with significant improvements in low contrast visual acuity. With acute optic neuritis often manifesting as the first sign of multiple sclerosis or as a frequent MS relapse type, these results highlight the potential of this neuroprotective candidate to transform outcomes for patients experiencing acute relapses of this autoimmune disease.”
Céline Louapre, M.D., Ph.D., is the Head of Neuroscience Clinical Investigation Center at the Paris Brain Institute, Pitié-Salpêtrière Hospital, where more than 80 clinical trials are currently conducted in the field of neuroscience. As a clinical neurologist with a Ph.D. in neuroscience, she is particularly interested in bringing new MRI technical developments to study the pathophysiologic mechanisms of MS, and in developing translational clinical research to foster remyelination and neuroprotection. She also serves as the Medical Coordinator of the National Multiple Sclerosis Clinical Research Network, FCRIN4MS, and as a Professor of Neurology at Sorbonne University, Pitié-Salpêtrière Hospital.
About Privosegtor (OCS-05)
Privosegtor is a novel peptoid small molecule candidate with the potential to become a neuroprotective therapy for optic neuritis and other neuro-ophthalmic diseases. The recent positive topline results from the ACUITY Phase 2 trial showed Privosegtor (OCS-05)’s neuroprotective benefits, including anatomical preservation of the retina and improvements in visual function, in patients suffering from acute optic neuritis. Consistent results were observed in animal models of neuroinflammation and neurodegeneration where Privosegtor showed preservation of retinal ganglion cell damage and was associated with improvements in mobility (clinical function disability). Privosegtor has received orphan drug designation from both the FDA and the EMA for acute optic neuritis. In addition to this indication, a neuroprotective treatment could potentially have wide applicability in neuro-ophthalmic and neurology indications.
Privosegtor is an investigational drug in Phase 2 and has not received regulatory approval for commercial use in any country.
About Acute Optic Neuritis
Acute optic neuritis is a rare condition characterized by acute inflammation of the optic nerve, which can lead to permanent visual impairment. It affects up to 8 in 100,000 people worldwide and often represents the first sign of multiple sclerosis1. It mainly occurs in adults between the ages of 20 and 40 years and is more frequent in women (2:1)2. The acute inflammatory process of acute optic neuritis results in the loss of myelin covering the optic nerve and its axons. Initially, patients often experience ocular pain that worsens with eye movement, and vision loss. Once the inflammation recedes, remyelination usually occurs but it is incomplete. Without the myelin sheath protecting the axon, neurons located in demyelinated segments become fragile and prone to death, as early as the first weeks following symptoms onset. Unfortunately, damaged axons cannot regrow, leading to permanent visual impairment. To date there is no neuroprotective therapy approved for acute optic neuritis and unmet needs remain for medicines that can prevent vision loss after an acute episode of optic neuritis.
About Oculis
Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on innovations addressing ophthalmic and neuro-ophthalmic conditions with significant unmet medical needs. Oculis’ highly differentiated late-stage clinical pipeline includes three core product candidates: OCS-01, an eye drop in pivotal registration studies, aiming to become the first non-invasive topical treatment for diabetic macular edema; Privosegtor (OCS-05), a neuroprotective candidate in Phase 2 for acute optic neuritis, with potentially broad clinical applications in various neuro-ophthalmic and neurological diseases; and Licaminlimab (OCS-02), a novel, topical anti-TNFα in Phase 2, being developed with a genotype-based approach to drive personalized medicine in dry eye disease. 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 supported by leading international healthcare investors.
For more information, please visit: www.oculis.com
| (1) | Martínez-Lapiscina EH, et al. (2014): Is the incidence of optic neuritis rising? Evidence from an epidemiological study in Barcelona (Spain) 2008-2012. J Neurol. 2014 Apr; 261(4): 759-767. |
| (2) | Pérez-Cambrodí RJ, Gómez-Hurtado Cubillana A, Merino-Suárez ML, Piñero-Llorens DP, Laria-Ochaita C. Optic neuritis in pediatric population: a review in current tendencies of diagnosis and management. J Optom. 2014 Jul-Sep;7(3):125-30. |
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of Privosegtor (OCS-05), including patient impact and market opportunity; the potential of Privosegtor (OCS-05) to become a first-in-class neuroprotective therapy for acute optic neuritis and other neuro-ophthalmic diseases; 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.
Oculis Contacts
Ms. Sylvia Cheung, CFO
sylvia.cheung@oculis.com
Investor Relations
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Media Relations
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oculis@icrhealthcare.com
FAQ
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