A potential world first treatment for acute adenoviral conjunctivitis (commonly known as viral conjunctivitis) will be evaluated in an Australian Phase II trial (RUBY) led by Professor Stephanie Watson of Save Sight Institute and The University of Sydney.
The trials will evaluate the safety and efficacy of OKG-0301, a lead therapy developed by biotechnology company Okogen.
Adenoviral conjunctivitis is a highly contagious disease that affects up to 25 million people worldwide each year, making it the number one cause of eye infections globally.
Bacterial conjunctivitis is typically treated with antibiotics including eye drops or ointments, however these do not work in treating viral forms of the infection. Despite the high incidence of viral conjunctivitis, there are no approved therapies for the disease, and care is mainly supportive.
The infection can persist for up to three weeks, and patients are highly contagious for 10–14 days. This puts families and communities, including schools and daycare centres, at risk for rapid spread of the infection and persistence of the virus within the population.
“Antibiotics are not the answer to viral conjunctivitis. Their use has the potential to lead to future infections with multi-drug resistance, and delays proper eye care, which can lead to longer term and more significant negative outcomes on eye health,” said Brian M. Strem, CEO at Okogen.
“These trials in Australia are hugely important for the development of the world’s first effective treatment for conjunctivitis. To be eligible for our trials, candidates must commence treatment with us within three days of first reporting a presence of viral conjunctivitis symptoms.”
The RUBY trial, a phase II, multi-site, randomised, placebo controlled, double blinded clinical trial, will evaluate multiple doses of OKG-0301 in 219 adult patients with acute adenoviral conjunctivitis. Patients affected by adenoviral conjunctivitis suffer eye redness with swelling and ocular discharge, accompanied by symptoms including pain, itching, and foreign body sensation.
Prof. Watson said she was excited to coordinate the trials which will take place at Save Sight Institute, Sydney Eye Hospital, Sydney; Lions Eye Institute, Perth; Royal Adelaide Hospital, Adelaide; Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne; Hobart Eye Clinic, Hobart; Albury Eye Clinic, Albury; and the University of New South Wales, Sydney.
“I have been impressed with the consistent results of OKG-0301 in laboratory models of adenoviral conjunctivitis,” she said. “My fellow investigators and I are excited to have the opportunity to evaluate how this novel antiviral therapy may be able to help patients suffering from this very common condition.”
In addition to testing efficacy, investigators will assess OKG-0301’s safety and potential to diminish longer term complications of adenoviral infection that negatively affect vision and lead to scarring of the ocular surface.
To find out more about the RUBY trial, visit www.rubytrial.com.au