Oculis Announces Positive Topline Results of Phase 2b RELIEF Trial with Licaminlimab, Designed to Transform the Treatment Paradigm of Dry Eye Disease with a Precision Medicine Strategy

ZUG, Switzerland, June 10, 2024 (GLOBE NEWSWIRE) —

  • Improvements in multiple sign efficacy endpoints were observed in full population and with predictive and more pronounced effects in the TNFR1 genetic biomarker population as identified in prior successful Phase 2 symptoms trial
  • Rapid treatment effect on corneal inflammation was observed in TNFR1 genetic biomarker patients as early as Day 15 and was statistically significant at final efficacy visit on Day 43
  • Licaminlimab was well tolerated similar to vehicle
  • Company plans to finalize Phase 3 development plans following an End-of-Phase 2 (EoP2) meeting with the U.S. Food and Drug Administration (FDA)
  • An investor and analyst webcast will be held today at 8:30am US Eastern Time

Oculis Holding AG (Nasdaq: OCS) (“Oculis”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced positive topline results from its Phase 2b RELIEF trial with licaminlimab, a novel anti-TNFα biologic eye drop with an established dual anti-inflammatory and anti-apoptotic mechanism of action in patients with dry eye disease (DED).

The Phase 2b RELIEF trial is a multi-center, randomized, double-masked, vehicle-controlled trial evaluating the efficacy and safety of licaminlimab in subjects with signs of DED (NCT05896670). The trial also evaluated the efficacy and safety of licaminlimab in a subpopulation of subjects with a TNFR1-related genotype as prespecified in the protocol. One hundred and twenty-two (122) patients were randomized 1:1 to either licaminlimab (n=62) or vehicle (n=60) across 4 sites for a 6-week treatment period and a 2-week follow up. A total of 23 patients carried a specific TNFR1-related genotype. Patients were evaluated for efficacy endpoints at baseline, Day 15 and Day 43. The prespecified investigational efficacy measures in this trial included multiple signs of DED that are accepted by the FDA as efficacy endpoints.

Phase 2b RELIEF trial showed positive effects on multiple signs of DED

  • For the full trial population (n=122):
    • Treatment effect favoring licaminlimab was observed in multiple sign endpoints including fluorescein staining in the total cornea, inferior corneal, central corneal and nasal conjunctival regions, and in the Schirmer’s test.
  • For the subpopulation of patients with the TNFR1 genetic biomarker (n=23):
    • Treatment effect favoring licaminlimab was observed in multiple sign endpoints including fluorescein staining in the total cornea, inferior corneal, central corneal, nasal conjunctival, total conjunctival and total ocular surface regions, in the Schirmer’s test, and in conjunctival redness.
    • Rapid and favorable treatment effect in favor of licaminlimab on corneal inflammation was observed as early as Day 15 that was significant at Day 43, as measured by the difference in mean change from baseline versus vehicle for inferior corneal fluorescein staining score: -0.59 (CI: -1.165, -0.017). The treatment effect also increased over time. See attached Figure.
    • Licaminlimab was well tolerated. The incidence of ocular TEAEs in the study eye was 11.5% in the licaminlimab group and 10.2% in the vehicle group. TEAEs in the fellow eye were similar to the study eye. All ocular TEAEs were mild and transient, and there were no serious ocular adverse events observed with licaminlimab in the study. Drop comfort was also evaluated and was similar to artificial tears.

Riad Sherif, MD, Chief Executive Officer of Oculis, commented: “We are pleased that we achieved all of our objectives for the trial, and extremely encouraged to see licaminlimab’s profound results with a precision medicine approach which has the potential to transform the way we develop drugs and treat patients in ophthalmology. With this and prior positive results on signs and symptoms, we look forward to discussing these encouraging data with the FDA and advancing this program into Phase 3.”

Eric Donnenfeld, M.D., Clinical Professor of Ophthalmology at New York University and Chair of Oculis’ Cornea Scientific Advisory Board, added: “The precision medicine approach with licaminlimab could be a groundbreaking paradigm shift in ophthalmology and the treatment of DED. The current approach of ‘trial and error’ and our inability to predict response for this highly heterogenous population leads to a low level of patient satisfaction. To my knowledge, Licaminlimab is the first dry eye disease medication to demonstrate in a clinical trial a predictive treatment effect in patients with a common genetic biomarker to potentially solve this problem.”

Christophe Baudouin, M.D., Ph.D., Professor of Ophthalmology and Chairman of Ophthalmology III at Quinze-vingts National Ophthalmology Hospital, Paris, and member of Oculis Scientific Advisory Board, added: “I am very excited to see that licaminlimab, with its dual anti-inflammatory and anti-apoptotic mechanism of action, targets the origin of DED and has the potential to be truly disease modifying as shown by improvements in several clinical signs of DED, including corneal staining.”

The Company is planning to conduct an end-of-Phase 2 meeting with the FDA to discuss the registrational path for licaminlimab in DED and finalize the Phase 3 development plan.

Analyst and investor call
The Oculis management team will host an analyst and investor call today at 8:30 am US Eastern Time, to review the trial results.

Interested parties may participate in the call via the following webcast here.

A replay of the webcast and accompanying slides will be available for 90 days following the event through the “Events and Presentations” page of the “Investors and Media” section of the company’s website.

About Dry Eye Disease (DED)
DED is a common condition estimated to impact nearly 40 million people in 2023 in the US alone1. It is a multifactorial disease in which ocular surface inflammation plays a central role in sustaining the pathological state2,3. 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 disease1. However, only 13% receive prescription treatment, primarily with an anti-inflammatory medications1. Despite currently available treatments, with 87% of chronic patients still unsatisfied4 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 more personalized treatment approaches to improve outcomes for patients.

About licaminlimab (OCS-02)
Licaminlimab is an anti-TNFα eye drop candidate 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 multiple Phase 2 trials, licaminlimab has shown positive effects on treating both the signs and symptoms of DED and has been well tolerated. In addition, a genetic biomarker was identified which showed a clear correlation between this variant in the TNFR1 gene and improved response to licaminlimab.

Licaminlimab is an investigational drug and has not received regulatory approval for commercial use in any country. For more information, please visit: www.oculis.com

About Oculis

Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) purposefully driven to save sight and improve eye care. Oculis’ highly differentiated pipeline comprises multiple innovative product candidates in development. It includes OCS-01, a topical eye drop candidate for diabetic macular edema (DME) and for the treatment of inflammation and pain following cataract surgery; licaminlimab (OCS-02), a topical biologic anti-TNFα eye drop candidate for dry eye disease (DED) and for non-infectious anterior uveitis; and OCS-05, a neuroprotective candidate for acute optic neuritis (AON). Headquartered in Switzerland and with operations in the U.S. and Iceland, Oculis’ goal is to improve the health and quality of life of patients worldwide. The company is led by an experienced management team with a successful track record and is supported by leading international healthcare investors.

Oculis Contacts
Ms. Sylvia Cheung, CFO

Investor & Media Relations
LifeSci Advisors
Corey Davis, Ph.D.

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of licaminlimab, including patient impact and market opportunity; the potential of licaminlimab for treating DED; expected future milestones and catalysts; the initiation, timing, progress and results of Oculis’ clinical and preclinical studies; Oculis’ research and development programs, regulatory and business strategy, future development plans, and management; Oculis’ ability to advance product candidates into, and successfully complete, clinical trials; and the timing or likelihood of regulatory filings and approvals, are forward-looking. The clinical trial results presented in this press release are topline and preliminary and subject to change, as analysis is ongoing. These topline results may not be reproduced in subsequent patients and clinical trials. 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 any other documents filed with the U.S. Securities and Exchange Commission (the “SEC”). Copies of these documents are available on the SEC’s website, www.sec.gov. Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

DRG (part of Clarivate) – Dry Eye Disease Landscape and Forecast report 2020
TFOS DEWS II The Ocular Surface 15 (2017)
3 Baudouin C. Dry Eye Disease, the complex interactions of vicious cycles. EuDES European Dry Eye Society
Mukamal, R. Why is Dry Eye So Difficult to Treat? 2021 https://www.aao.org/eye-health/tips-prevention/fix-dry-eye-treatment-eyedrops


SCHOTT Pharma appoints Tobias Erfurth as Head of Investor Relations

  • Tobias Erfurth will lead Investor Relations Team starting in August 2024.
  • He brings more than 20 years of experience in finance, capital markets and investor relations.

SCHOTT Pharma, a pioneer in pharma drug containment solutions and delivery systems, today announced the appointment of Tobias Erfurth as Head of Investor Relations effective August 2024. He will strengthen and expand the Investor Relations team at SCHOTT Pharma and will report to CFO Almuth Steinkühler. “Tobias joining our finance team is a real win for SCHOTT Pharma. With his extensive expertise and DAX40 experience, we look forward to further growing SCHOTT Pharma’s presence in the capital markets and showcasing our attractive financial profile,” said Dr. Almuth Steinkühler, CFO of SCHOTT Pharma.

Tobias Erfurth has gained more than 20 years of experience in finance, capital markets and investor relations, both from corporate positions and roles in banking. In his most recent position as Head of Investor Relations at Symrise AG for over 13 years, Erfurth was responsible for managing all investor activities during the company’s development from a small cap to a member of the DAX40. Prior to that, Erfurth accompanied the IPO of Crop Energies AG and subsequently built up the investor relations department. Erfurth also has extensive experience in corporate finance and equity capital markets gained in his previous role as analyst at Dresdner Bank.

“With its convincing equity story, dynamic growth, attractive margins, SCHOTT Pharma is a true success story, and I look forward to joining the team. Together, we will continue to deepen the established relationships with investors and analysts and help key stakeholders to understand SCHOTT Pharma’s strategy and its role as a pioneer in one of the fastest growing markets of the pharma industry,” said Tobias Erfurth.

For additional news about SCHOTT Pharma please visit our media center.

About SCHOTT Pharma

Human health matters. That is why SCHOTT Pharma designs solutions grounded in science to ensure that medications are safe and easy to use for people around the world. The portfolio comprises drug containment solutions and delivery systems for injectable drugs ranging from prefillable glass and polymer syringes to cartridges, vials, and ampoules. Every day, a team of over 4,600 people from over 60 nations works at SCHOTT Pharma to contribute to global healthcare. The company is represented in all main pharmaceutical hubs with 16 manufacturing sites in Europe, North and South America, and Asia. With over 1,000 patents and technologies developed in-house and a state-of-the-art R&D center in Switzerland, the company is focused on developing innovations for the future. SCHOTT Pharma AG & Co. KGaA is headquartered in Mainz, Germany and listed on the Frankfurt Stock Exchange as part of the SDAX. It is part of SCHOTT AG, which is owned by the Carl Zeiss Foundation. In light of this spirit, SCHOTT Pharma is committed to sustainable development for society and the environment and has the strategic goal of becoming climate-neutral by 2030. Currently, SCHOTT Pharma has over 1,800 customers including the top 30 leading pharma manufacturers for injectable drugs and generated revenue of EUR 899 million in the fiscal year 2023.


Press contact

Joana Kornblum

Media Relations

Tel.: +49 151/29223552

E-Mail: joana.kornblum@schott.com

Investor contact

Jasko Terzic, CFA

Senior Manager Investor Relations

E-Mail: ir.pharma@schott.com


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VERAXA Biotech AG acquires Synimmune GmbH to expand cancer pipeline

Zurich, 29th of December 2023: VERAXA Biotech AG, a pioneering company in the development of superior antibody-based cancer therapies and a portfolio company of Xlife Sciences AG (SIX: XLS), is proud to announce the acquisition of Synimmune GmbH and its innovative Phase I antibody (FLYSYN) for the treatment of Acute Myeloid Leukemia (AML). This marks a major milestone in the company’s history and with the expansion of VERAXA’s cancer pipeline it is hope for patients battling AML – one of the most common types of acute leukemia in adults.

The FLYSYN antibody was acquired by VERAXA Biotech AG from Xlife Sciences AG portfolio company Synimmune GmbH via a share deal. The deal included an upfront payment as well as several milestones and will reach a total deal value of up to 32 million EUR. With this clinical asset, VERAXA strengthens its internal cancer pipeline of innovative antibodies and antibody-drug conjugates (ADCs).

AML, characterized by its prevalence in individuals over the age of 68 and accounting for approximately 1% of all cancer occurrences, has long presented a challenge in the medical community, particularly for those under 45 where it is less common. The successful First-in-Man multicenter clinical study of FLYSYN focused on patients with AML who had measurable residual disease (MRD). The introduction of FLYSYN, is a testament to VERAXA Biotech AG’s commitment to advancing healthcare and providing innovative solutions for serious health conditions.

Oliver R. Baumann, CEO of Xlife Sciences AG comments: «Securing the innovative Phase I antibody, FLYSYN, for Acute Myeloid Leukemia (AML) treatment marks a significant step forward. This milestone reflects our commitment to advancing healthcare and sets the stage for a promising future in reshaping AML treatment. »

Dr. Christoph Antz, CEO of VERAXA Biotech AG, stated: «With FLYSYN, we are one step closer to offering better, more effective treatments for those affected by Acute Myeloid Leukemia. »

As we continue to navigate the complexities of AML treatment, VERAXA Biotech AG remains steadfast in its mission to transform the landscape of medical care. For more information about VERAXA Biotech AG and our work in AML treatment, please visit www.veraxa.com.


Financial calendar

Annual Report 2023 23 April 2024
Annual Shareholders Meeting 2024 20 June 2024
Half-Year Report 2024 19 September 2024

Information for investors and journalists: Xlife Sciences AG, Dr. Dennis Fink, dennis.fink@xlifesciences.ch
Information related to VERAXA Biotech AG: Dr. Christoph Antz, antz@veraxa.com

Xlife Sciences AG 
Talacker 35, 
8001 Zurich, Switzerland,
Phone +41 44 385 84 60
info@xlifesciences.ch, www.xlifesciences.ch 
Commercial Register Zurich CHE-330.279.788 
Stock Exchange: SIX Swiss Exchange

End of Inside Information

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A new clinical study highlights efficiency in spine surgery of NextAR Spine, augmented reality surgical application

A new clinical study highlights efficiency in spine surgery of NextAR Spine, augmented reality surgical application

CASTEL SAN PIETRO, 14 December 2023 – Medacta Group SA (“Medacta”, SIX:MOVE), a Swiss company specializing in the design, production, and distribution of innovative, personalized, and sustainable solutions for joint replacement, sports medicine, and spine surgeries, announces the publication of a new study in the European Spine Journal which demonstrates that NextAR Spine seamlessly integrates into the OR workflow, enabling the surgeon to enhance efficiency, accuracy, and versatility in spine surgery.

“Precision and accuracy in spine surgery is critical. As stated in our recent study, NextAR, the new AR-assisted navigation system, greatly simplifies pedicle screw placement, ensuring effectiveness and accuracy. It’s a reliable tool, straightforward to use, and it elevates our ability to provide safe and precise navigation for various spinal conditions,” says Professor Dr. med. Bernhard Meyer, Director of the Neurosurgical Clinic and Policlinic at the University Hospital Rechts der Isar, Munich.

The study “Evaluating a cutting‑edge augmented reality‑supported navigation system for spinal instrumentation”1 led by Prof. Dr. med. Bernhard Meyer, evaluates the efficiency, accuracy, and versatility of NextAR Spine, a navigation system that incorporates augmented reality to provide unique real-time surgical guidance, superimposed onto the operative field, enhancing precision and enabling data-driven decision-making in the placement of pedicle screws, and addressing different types of spine indications, such as trauma, degeneration, infection, and tumor.

The placement of pedicle screws has been achieved with precision using both open and percutaneous approaches in both long and short constructs, indicating a lower intraoperative revision rate (1.7%)1 compared to the rate documented in the scientific literature with other navigation systems (3.4% by Ille at al2; 4.7% by Ryang at al3). This further highlights that NextAR Spine proves to be a reliable and safe tool for 3D imaging-based pedicle screw placement while requiring minimal setup during surgery, in line with Medacta’s philosophy of healthcare sustainability. The setup is reduced to a minimum by integrating the cameras into the surgical instruments and establishing a flexible platform which includes the preoperative planning.

The NextAR platform is offered as a hardware system with limited capital investment and single-use instrumentation at a low cost per case and offers the ability to host software for multiple applications (NextAR Knee, NextAR Shoulder, NextAR Spine, and Hip applications). The platform represents an optimal solution worldwide, particularly for US Ambulatory Surgery Centers (ASCs).

The NextAR surgical platform is part of Medacta’s MySolutions Personalized Ecosystem, a network of advanced digital solutions designed to improve patient outcomes and healthcare efficiency. MySolutions embodies Medacta’s holistic approach to personalized medicine, aiming at bringing value to every step of the patient’s journey, from preoperative through postoperative care.

NextAR is also supported by the comprehensive, tailored educational offerings provided by the M.O.R.E. Institute. With an international network of expert surgeons, the M.O.R.E. Institute is at the forefront of education on spine procedures and products with personalized high-level educational pathways. With Medacta, the surgeon is never alone.

[1] Schwendner M, Ille S, Wostrack M, Meyer B. Evaluating a cutting-edge augmented reality-supported navigation system for spinal instrumentation. Eur Spine J. 2023 Nov 14. doi: 10.1007/s00586-023-08011-w. Epub ahead of print. PMID: 37962688.
[2] Ille S, Baumgart L, Obermueller T, Meyer B, Krieg SM (2021) Clinical efficiency of operating room-based sliding gantry CT as compared to mobile cone-beam CT-based navigated pedicle screw placement in 853 patients and 6733 screws. Eur Spine J 30(12):3720–3730. https:// doi. org/ 10. 1007/ s00586- 021- 06981-3
[3] Ryang YM, Villard J, Obermuller T et al (2015) Learning curve of 3D fluoroscopy image-guided pedicle screw placement in the thoracolumbar spine. Spine J 15(3):467–476. https:// doi. org/ 10. 1016/j. spinee. 2014. 10. 003    


Medacta International SA
Gianluca Olgiati     
Senior Director Global Marketing  
Phone: +41 91 696 60 60


About Medacta

Medacta is an international company specializing in the design, production, and distribution of innovative orthopaedic products, as well as in the development of accompanying surgical techniques. Established in 1999 in Switzerland, Medacta is active in joint replacement, spine surgery, and sports medicine. Medacta is committed to improving the care and well-being of patients and maintains a strong focus on healthcare sustainability. Medacta’s innovation, forged by close collaboration with surgeon experts globally, began with minimally invasive surgical techniques and has evolved into personalized solutions for every patient. Through the M.O.R.E. Institute, Medacta supports surgeons with a comprehensive and tailored program dedicated to the advancement of medical education. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 50 countries. Follow us on Medacta TV, YouTube, LinkedIn, and X.




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File: MEDIA RELEASE – A new clinical study highlights efficiency in spine surgery of NextAR Spine, augmented reality surgical application

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