A Melbourne-based biotech, PolyActiva, has attracted $16 million in venture capital for a clinical trial of a unique eye implant that experts say can sharply improve treatment of the blindness-causing condition.
PolyActiva’s ‘polymer prodrug’ technology virtually eliminates human error by delivering the solution via a tiny ocular implant that is almost invisible alongside a 5¢ piece.
Implant biodegrades and disappears within 90 days
The implant can be inserted in the eye using a customised applicator in an ophthalmologist’s office. Once the treatment is completed the implant biodegrades and disappears within 90 days.
Reliably delivering drugs to the eye without the need for human intervention is a ‘holy grail’ for ophthalmologists.
Current treatment requires the patient to self-administer four drops of latanoprost ophthalmic solution – a topical medication known by the brand Xalatan – for six months, an exacting task that studies suggest defies 46 per cent of patients in some way.
Patients may forget to take the drops or do it poorly, which is bad because untreated glaucoma – a build up of pressure on the eye that the drops can relieve – often leads to blindness.
Seven patients in phase 1 clinical trial
Investors, led by Brandon Capital’s Medical Research Commercialisation Fund and Yuuwa Capital, a Perth-based early stage commercialisation fund, have stumped up the $16 million to fund phase I clinical trials of the implant on seven patients at Melbourne’s Royal Eye and Ear Hospital.
Glaucoma is the second leading cause of irreversible blindness globally, affecting an expected 80 million people worldwide by 2020.
In the United States, more than 120,000 people are blind from glaucoma, accounting for 9 per cent to 12 per cent of all cases. The global glaucoma market may be worth more than $US1 billion ($A1.4 billion).
Implant can be inserted in ophthalmologist’s practice
The implant can be inserted in the eye using a customised applicator in an ophthalmologist’s practice. Once the treatment is completed the implant biodegrades and disappears within 90 days.
PolyActiva’s prodrug technology outperforms rival products and has created excitement among practitioners, chief executive Dr Russell Tait said.
“Fundamentally what we do that’s different to everybody else is that we make the drug part of the polymer,” Dr Tait told The Australian Financial Review.
“We build them up together as a complex single polymer with the drug in it and that allows us to do things other people can only dream of.”
Rate of delivery controlled by rate of release
For example, PolyActiva can fine tune the drug and its delivery by controlling the rate of release, the form the drug is released in and how long the polymer lasts in the body.
Dr Chris Nave, chairman of PolyActiva and chief executive of the Medical Research Commercialisation Fund (MRCF), said one of the appeals of PolyActiva is that its drug-delivery technology has other applications, including antibiotics for eye infections, non-steroid anti-inflammatory drugs, steroids for cataract surgery patients and Beta-blockers.
The initial $16 million will also cover a phase one trial of a second implant that delivers an antibiotic. MRCF and Yuuwa chipped in about 60 per cent of the raising.
Results of phase 1 trial should be known by mid-2019
The phase one trial aims to show that the glaucoma implant is safe for humans and its results should be known by mid-2019. If it succeeds PolyActiva will seek additional funds to conduct a phase one B-trial involving about 20 patients with three different doses, to determine the optimal dose.
Dr Nave said some additional funds had already been reserved and funding further trials should be no problem because PolyActiva’s technology is generating “a fair bit of support and excitement from investors”.