June 2021
Volume 62, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2021
Efficacy and Safety of OCS-02 a novel, potent, topical TNFα antibody in acute anterior uveitis (AAU): a phase 2 study
Author Affiliations & Notes
  • Anat Galor
    Surgical Services, Miami VA Healthcare System, Miami, Florida, United States
    Ophthalmology, University of Miami Mary and Edward Norton Library of Ophthalmology, Miami, Florida, United States
  • Footnotes
    Commercial Relationships   Anat Galor, Dompe (C), Novaliq (C), Novartis (C), Oculis (C), Oyster Point (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2021, Vol.62, 3476. doi:
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      Anat Galor; Efficacy and Safety of OCS-02 a novel, potent, topical TNFα antibody in acute anterior uveitis (AAU): a phase 2 study. Invest. Ophthalmol. Vis. Sci. 2021;62(8):3476.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Due to the side effects of steroids, there is a medical need for new anti-inflammatory drugs to treat uveitis. Marketed TNFα antagonists are considered effective but are administered systemically. OCS-02 is a potent topical ocular anti-TNFα antibody fragment. This randomized, active-controlled study (ClinicalTrials.gov NCT02482129, registered 6/26/2015, study start 7/17/2015) assessed OCS-02 efficacy and safety in acute anterior uveitis (AAU) patients.

Methods : This was a Phase 2, multicenter, randomized, parallel-group, double-masked, active-controlled study. Dexamethasone was added for masking purposes with no inferential comparison to OCS-02. Patients aged ≥18 years with non-infectious AAU and Standardization of Uveitis Nomenclature anterior chamber (AC) cell score of 2+ or 3+ were recruited. Patients were randomized (3:1 ratio) to OCS-02 (60 mg/mL; 8 drops/day for 15 days, then 4 drops/day for 7 days, followed by matching vehicle for last 7 days to maintain masking with active control) or dexamethasone eye drops (8 drops/day for 15 days tapering to 1 drop/day over 14 days). The primary efficacy endpoint was Responder Status at Day 15- at least a two-step decrease in AC Cell Grade relative to baseline. Efficacy was determined if the Bayesian lower limit of the 95% posterior interval of the responder rate was >30%. Safety assessments included adverse events and ophthalmic examination.

Results : Twenty nine patients were treated with OCS-02 and 10 patients with dexamethasone. The Day 15 response rate in the OCS-02 arm was 56%; the lower bound of the 95% credible interval was 40%, i.e. >30%, thus demonstrating efficacy according to prespecified criteria. The proportion of patients with an AC Cell Grade of 0 increased from baseline to Day 29, despite the tapering and discontinuation of OCS-02 at Day 22: 76% had an AC Cell Grade of 0 on at least 1 post-treatment visit. Mean intra-ocular pressure was unchanged in the OCS-02 arm. There were no notable differences in ophthalmic examination results.

Conclusions : Administration of OCS-02, a novel TNFα antibody eye drop, demonstrated efficacy in resolving ocular inflammation in this phase 2 study of patients with AAU. The drug was well tolerated without steroid-type side effects or eye irritation suggesting its potential as a non-steroidal therapy for AAU. Confirmatory clinical studies are planned.

This is a 2021 ARVO Annual Meeting abstract.

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