PolyActiva, a clinical-stage Australian biotechnology company, has recruited first patients into its Phase I clinical study designed to show its glaucoma implant is safe and well tolerated.
The Melbourne-based company says it has used its proprietary polymer prodrug technology to develop ocular implants that, when placed in the eye, provide sustained treatment over a six-month period, compared to current glaucoma treatment where patients often need to administer four eye drops daily.
The technology could in the future mean people with open-angle glaucoma no longer need to use daily eye drops.
The potential to remove the reliance on the patient to remember to use eye drops is being heralded as a major potential health breakthrough.
Several studies have demonstrated that up to 46 per cent of patients have been found not to remember to use their drops or administer them poorly. Failure to adhere to treatment can lead to faster progression of glaucoma, one of the most common causes of blindness.
“This product is designed to make the lives of glaucoma sufferers easier by removing the need for daily drop administration and thus improving treatment management,” said PolyActiva CEO Dr Russell Tait. “The implant is designed to deliver treatment for six months after which it will disappear without further intervention. We’re excited about starting our first clinical study and look forward to seeing how our lead candidate performs.”
Glaucoma is the second leading cause of irreversible blindness globally. The global glaucoma market is estimated to be valued at over USD$1 billion.
“The major investors, MRCF and Yuuwa Capital, see this technology having a major potential impact on the lives of millions of glaucoma patients globally,” said Dr Chris Nave, chairman of PolyActiva and CEO of the Medical Research Commercialisation Fund (MRCF). “This innovative drug delivery technology has further potential applications, such as being used to administer other types of medication, including antibiotics and steroids for cataract surgery patients.”
The clinical trial will assess the safety and tolerance of the implant when administered to glaucoma patients. The implant is also designed to biodegrade within 90 days after the treatment period and is capable of being administered in an ophthalmologist’s office under a slit-lamp using a custom-designed administration device.
According to one of the lead investigators, ophthalmologist and cataract surgeon, Dr Nathan Kerr, “PolyActiva’s treatment approach offers significant potential benefits for patients, addressing adherence and improving treatment of this disease. The bespoke administration device is simple to use and intuitive to operate.”
The Phase I clinical trial is being conducted at the Royal Victorian Eye and Ear Hospital in Melbourne, through the Centre of Eye Research Australia (CERA). The Phase I clinical trial will see seven glaucoma patients enrolled to evaluate the safety and tolerability of its PA5108 ocular implant, with initial results expected in Q1 2019.
PolyActiva has secured investment funds to date exceeding $16 million from Australian-based venture capital firms Brandon Capital and Yuuwa Capital.
