June 2021
Volume 62, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2021
Acute Adenoviral Conjunctivitis Treatment: A Phase 2 Interim Analysis of OKG-0301
Author Affiliations & Notes
  • Stephanie L Watson
    Clinical Ophthalmology and Eye Health, Save Sight Institute, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia
  • Robert Casson
    Ophthalmology, Royal Adelaide Hospital, Adelaide, South Australia, Australia
  • Mei-Ling Tay-Kearney
    Lions Eye Institute, Nedlands, Western Australia, Australia
  • Eric Daniels
    Okogen Pty Ltd, Melbourne, Victoria, Australia
  • Brian Strem
    Okogen Pty Ltd, Melbourne, Victoria, Australia
  • Paul Giles
    Albury Eye Clinic, Albury, New South Wales, Australia
  • Nitin Verma
    Hobart Eye Surgeson, Hobart, Tasmania, Australia
  • Naomi Liebenberg
    Browns Plains Family Practice, Browns Plains, Queensland, Australia
  • Hans Bloom
    Vale Medical Practice, Brookvale, New South Wales, Australia
  • Fred Faigenbaum
    Mirrabooka Medical Centre, Mirrabooka, Western Australia, Australia
  • Mark Daniell
    Ophthalmology, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia
  • Footnotes
    Commercial Relationships   Stephanie Watson, Okogen Pty Ltd (C); Robert Casson, Okogen Pty Ltd (F); Mei-Ling Tay-Kearney, Okogen Pty Ltd (F); Eric Daniels, Okogen Pty Ltd (E); Brian Strem, Okogen Pty Ltd (E); Paul Giles, Okogen Pty Ltd (F); Nitin Verma, Okogen Pty Ltd (F); Naomi Liebenberg, Okogen Pty Ltd (F); Hans Bloom, Okogen Pty Ltd (F); Fred Faigenbaum, Okogen Pty Ltd (F); Mark Daniell, Okogen Pty Ltd (F)
  • Footnotes
    Support  Sydney Medical School Foundation Fellowship
Investigative Ophthalmology & Visual Science June 2021, Vol.62, 404. doi:
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      Stephanie L Watson, Robert Casson, Mei-Ling Tay-Kearney, Eric Daniels, Brian Strem, Paul Giles, Nitin Verma, Naomi Liebenberg, Hans Bloom, Fred Faigenbaum, Mark Daniell; Acute Adenoviral Conjunctivitis Treatment: A Phase 2 Interim Analysis of OKG-0301. Invest. Ophthalmol. Vis. Sci. 2021;62(8):404.

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

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Purpose : Treatment of acute adenoviral conjunctivitis remains an unmet medical need, with no approved therapies available worldwide. OKG-0301 is a topical ophthalmic formulation of ranpirnase, an RNAse A family member, with broad-spectrum antiviral properties.

Methods : The RUBY trial is a 219 patient, prospective, multi-center, double-blind, vehicle controlled, Phase 2 trial evaluating the safety, tolerability, and efficacy of OKG-0301 0.03% and OKG-0301 0.012% versus vehicle. Patients within 72 hours of the onset of signs and symptoms of adenoviral conjunctivitis, along with a positive QuickVue (Quidel) adenoviral conjunctivitis test were randomized and dosed in both eyes QID for five days. Four visits at days 1, 4, 7, & 14, each included a clinical assessment and an ocular swab for viral titer determination. The primary outcome was safety and tolerability of OKG-0301 and secondary outcomes included viral titer (Least Square Means [LSMean] comparison) and clinical assessments, including redness and discharge. An interim analysis was performed to evaluate the initial safety and efficacy of OKG-0301.

Results : Fifty-eight subjects were randomized and included in the Intent To Treat (ITT) population. The modified ITT (mITT), defined prospectively as subjects with > 100 viral copies/mL via PCR at visit 1 and who received at least a single dose of investigational product, included 41 patients. In the ITT population, there were no Treatment Emergent Serious Adverse Events and one patient with a Treatment Emergent Adverse Event suspected due to study medication in the vehicle control group. In the mITT evaluation, OKG-0301 had an antiviral effect via reduction of viral titers relative to placebo (day 7 placebo vs OKG-0301 0.012% vs OKG-0301 0.03% (LOG10 transformed, LSMean +/- SE): 1.06 +/- 0.22 vs 0.34 +/- 0.27 vs 0.62 +/-0.27, respectively, p<0.05; Fig 1). There was neither a better nor worse (NS = non-significant) difference in the clinical resolution of redness and discharge in the active vs placebo groups at day 7.

Conclusions : OKG-0301 is a safe and effective antiviral for the treatment of acute adenoviral conjunctivitis. Its main biological activity appears to be limited to acceleration of viral eradication, with no observed effect on redness and discharge. Further formulation and additional clinical evaluation is warranted to develop OKG-0301 as the first approved treatment of acute adenoviral conjunctivitis.

This is a 2021 ARVO Annual Meeting abstract.



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