Okogen, a biotech company developing ophthalmic therapeutics, has announced that Eye Clinic Albury Wodonga is actively seeking more patients for a clinical study of viral conjunctivitis, the #1 cause of eye infections globally.
The Phase II clinical study, known as the RUBY Trial, will evaluate the safety and efficacy of Okogen’s lead candidate, OKG-0301, in the treatment of the highly contagious adenoviral conjunctivitis, affecting up to 25 million people worldwide each year.
Eye Clinic Albury Wodonga is one of seven trial sites participating in RUBY, and with enquiries regarding influenza already at the highest level in the past six years (according to the federal government), the clinic is actively enrolling further patients into the trial. To qualify for the trial, patients with viral conjunctivitis must be enrolled within three days of first exhibiting symptoms.
“We’ve already enrolled our first patients into the trial here in Albury, and with the winter cold we are expecting to see more and more people. Flu season typically aligns with a spike in conjunctivitis cases, so if you are experiencing irritation, red eyes, discharge from the eyes, or finding that your eyelashes are sticking together, seek medical advice quickly,” says Dr Paul Giles, Eye Clinic Albury Wodonga.
While bacterial conjunctivitis is typically treated with antibiotics, these drugs 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.
Viral conjunctivitis 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 centers, at risk for rapid spread of the infection and persistence of the virus within the population.
Okogen is a San Diego and Melbourne-based, clinical-stage, specialty biotechnology company focused on developing therapeutics to help patients with ocular diseases. The company’s lead development candidate, OKG-0301, is a broad-spectrum antiviral that functions intracellularly to inhibit viral replication and reduce ocular inflammation. These mechanisms of action are expected to provide clinical benefit in addressing adenoviral infections of the eye as well as other classes of viruses that are active in the ocular space, including herpes simplex virus, varicella-zoster virus, picornavirus, and more.
OKG-0301 is based on ranpirnase, the active pharmaceutical ingredient (API) previously advanced to late stage clinical trials in oncology. As an IV formulation, this API has been administered to over 800 patients as part of clinical testing, in addition to a significant amount of preclinical toxicology and CMC. These data highlight a strong safety profile, as well as a validated, commercial-scale manufacturing process.
About Adenoviral Conjunctivitis
Worldwide, adenoviral conjunctivitis is the most common eye infection, affecting up to 25 million individuals annually. The condition is a leading ocular disease, responsible for over 1% of all primary care visits. Most cases involve eye redness with varying degrees of swelling and ocular discharge, accompanied by clinical symptoms including pain, itching, and a foreign body sensation. The highly contagious infection lasts for 2-3 weeks, with patients remaining contagious for 10-14 days after the first onset of disease. Transmission to family members or close contacts is extremely common and patients are advised to avoid work and/or school until symptoms fully resolve.