Topical treatment for acute adenoviral conjunctivitis shows positive phase 2 results
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Interim results from a phase 2 study showed that Okogen’s topical OKG-0301 provided a safe and effective dose-dependent antiviral response in patients with acute adenoviral conjunctivitis, according to a poster presented at ARVO.
“OKG-0301 performed in the clinic exactly how it has worked in the laboratory,” Stephanie L. Watson, BSc(Med), MBBS, PhD, FRANZCO, who presented the data, said in a press release from Okogen. “In our patients, the drug clearly knocked down virus relative to placebo, and this is the foundation to any antiviral drug. By co-formulating OKG-0301 with a safe and well-understood ocular decongestant, we have line of sight to the development of the first drug available to treat this highly infectious condition.”
The double-blind, vehicle controlled RUBY trial involved 219 patients. After onset of signs and symptoms of adenoviral conjunctivitis and a positive QuickVue (Quidel) test, patients received either 0.03% or 0.012% dose of OKG-0301 or placebo in both eye for 5 days.
The researchers randomized 58 patients into an intent-to-treat (ITT) analysis and 41 patients who had received at least a single dose of OKG-0301 into a modified ITT analysis.
Patients in the ITT population displayed no treatment-related serious adverse events. Among those in the modified ITT population, both doses of OKG-0301 showed an antiviral effect via reduction of viral titers compared with placebo.
The researchers noted there was no significant difference in the clinical resolution of redness and discharge between treatment and placebo groups at day 7.
Okogen stated in a press release that it has provided the FDA with its planned clinical development steps and expects to launch a phase 3 program in 2022.
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Watson SL. Acute adenoviral conjunctivitis treatment: A phase 2 interim analysis of OKG-0301. Presented at: ARVO (virtual meeting); May 1-7, 2021.
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