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Oculis announces publication of Phase 2 data showing topical eye drops anti-TNFa agent licaminlimab (OCS-02) relieves persistent ocular discomfort in severe dry eye disease



LAUSANNE, Switzerland, Aug 23, 2022 – (ACN Newswire) – Oculis S.A., (‘Oculis’) a worldwide ophthalmology company developing life-changing treatments to save lots of sight and improve eye care with breakthrough innovations, announces that the outcomes of the double blinded, multicenter and placebo controlled Phase 2 clinical trial assessing the result of topical licaminlimab (OCS-02) on global ocular discomfort in patients with severe dry eye disease (DED) (NCT02365519) has been published by the Clinical Ophthalmology journal. The publication is obtainable on the National Institutes of Health (NIH) website here. ( https://pubmed.ncbi.nlm.nih.gov/35821785/ )

The outcomes from the analysis show that the differ from baseline to Day 29 in the global ocular discomfort score, the principal efficacy endpoint, was statistically significantly greater for topical ocular licaminlimab (OCS-02) (-7.9) than for vehicle (-3.6) (90% CI -7.7, -0.8; p = 0.041). The percentage of patients having an improvement in global ocular discomfort score >20 from baseline to treatment day 29, one of many secondary efficacy endpoints, was statistically greater for licaminlimab (17.9%) in comparison to vehicle (4.7%) (p=0.018).

Licaminlimab (OCS-02) was well tolerated in this study, without major safety differences between licaminlimab (OCS-02) and vehicle treatment groups, no upsurge in intra-ocular pressure was observed.

Licaminlimab (OCS-02) is really a single-chain antibody fragment (scFv) that binds to and neutralizes the experience of human TNFa, with dual mechanism of action (MoA), anti-inflammation and anti-necrosis. Unlike full-length monoclonal antibodies, scFv fragments can penetrate ocular surface tissues when used as eye drops, because of the smaller size of the molecule giving it the potential to end up being the first approved topical biologic for DED.

Dry Eye is really a multifactorial disease where inflammation rapidly assumes a central role in sustaining the pathological state(1). The global prevalence of DED has been reported at 11.59%(2) , representing approximately 900 million people worldwide. In america alone, there’s currently between 16 million and 49 million those who have dry eye disease(3) . Significant unmet medical needs remain because of this large and growing patient population with only 9% of diagnosed patients in america receiving treatment(4) and despite current options, only 13% of patients are achieving lasting relief(5) .

Licaminlimab (OCS-02) happens to be being investigated by Oculis in Phase 2 clinical trials for the treating dry eye disease and uveitis.

Pr Christophe Baudouin, M.D., Professor of Ophthalmology and Chairman of Ophthalmology III in Quinze-vingts National Ophthalmology Hospital, Paris, commented: “There exists a true unmet medical dependence on the development of drugs with new MOA to take care of the inflammation mixed up in pathogenesis of DED. OCS-02 is obviously one which could fill that gap. In comparison with currently available treatment plans along with other product candidates in the DED pipeline, OCS-02 could are likely involved in the treating the underlying factors behind the condition given its anti-inflammatory and anti-necrosis benefits. I certainly anticipate the continued development and approval of OCS-02 in severe dry eye disease as these patients now have limited treatment plans.”

Riad Sherif, M.D., CEO of Oculis, said: “The Phase 2 data further reinforce our confidence in the potential of OCS-02 as a novel anti-inflammatory treatment for the effective management of Dry Eye Disease, also for other inflammatory eye diseases. With Phase 2b clinical trials of OCS-02 for the treating dry eye disease and uveitis which are planned to start out in the coming months, alongside on-going Phase 3 clinical trials of OCS-01 in diabetic macular edema and inflammation and pain following ocular surgery and a proof-of-concept (POC) trial of OCS-05 in acute optic neuritis, we look forward confidently to the further development of the Oculis Ophthalmology Franchise to handle significant unmet medical needs in key regions of ophthalmology.”

About Oculis

Oculis is really a global biopharmaceutical company purposefully driven to save lots of sight, improve eye care and address significant unmet medical needs with breakthrough innovations. Oculis’s highly differentiated pipeline includescandidates for topical retinal treatments, topical biologics and disease modifying treatments. With a presence in key international markets, Oculis is poised to provide life-changing treatments to patients worldwide. Headquartered in Lausanne, Switzerland sufficient reason for operations in Europe, the U.S. and China, Oculis is led by a skilled management team with an effective background and supported by leading international healthcare investors.

To learn more, please visit: www.oculis.com

Notes:

(1) Baudoin C. Dry Eye Disease, the complex interactions of vicious cycles. EuDESEuropean Dry Eye Society https://www.dryeye-society.com/resources/dry-eye-disease-complex-interactions-vicious-cycles

(2) Eric B Papas “The global prevalence of dry eye disease: A Bayesian view” 2021

(3) https://dryeyedirectory.com/dry-eye-statistics/

(4) DRG Dry Eye Disease Landscape and Forecast 2020

(5) Mukamal, R. How come Dry Eye SO HARD to take care of? 2021 https://www.aao.org/eye-health/tips-prevention/fix-dry-eye-treatment-eyedrops

Topic:News release summary

Source: Oculis S.A.


Sectors:BioTech, Healthcare & Pharm

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