Australian ophthalmology company PolyActiva has reportedly made a significant step forward in its work to provide long-term, reliable drug delivery for glaucoma patients.
The Melbourne-based firm presented new clinical data from its Phase 2 clinical trial for its novel glaucoma treatment technology, PA5108, at the Eyecelerator Conference in Chicago on 17 October and at AusBiotechInvest on 29 October.
A media release said 17 participants were recruited to receive two PA5108 Ocular Implants, 21 weeks apart and 15 participants had now reached 48 weeks on study.
PolyActiva reported:
- Statistically significant intraocular pressure (IOP) changes from baseline were observed for each mean diurnal measurement at Weeks 12, 21, 33 and 42 (p<0.0001);
- Clinically meaningful IOP reductions at 8am over 48 weeks were observed, with mean IOP reductions between 26 and 35%;
- 94% of participants did not require additional drop therapy over the 48-week treatment period; and
- The PA5108 implant to date has been found to be safe and generally well tolerated by trial participants and no adverse impact was observed on corneal endothelium following repeat dosing of PA5108 and 48 weeks of monitoring.
PolyActiva’s proprietary implant is designed to address the long-standing challenge of poor patient adherence with traditional eye drop therapy by ensuring accurate dosing over an extended period, potentially mitigating the risk of blindness associated with glaucoma progression.
“Glaucoma treatments today rely heavily on patient-administered eye drops, but adherence to this regimen is notoriously poor, with studies showing that 40-90% of patients stop using their drops correctly after just one year,” says Ms Vanessa Waddell, PolyActiva CEO.
The release said the implant, constructed from a biodegradable polymer, is designed for sustained drug delivery, and unlike other treatments on the market, PolyActiva’s implant rapidly degrades once the drug is released, allowing for repeat dosing.
“With more than 80 million glaucoma patients worldwide, the global demand for improved treatments is substantial, and excitingly, PolyActiva’s technology can potentially deliver therapies for other ocular diseases,” the release said.
PolyActiva is now preparing for a phase 2b clinical trial of PA5108.
More reading
Positive results for PolyActiva biodegradable implant for glaucoma
Dr Elvis Ojaimi first to implant telescopic lens at Epworth Freemasons, Melbourne
Glaukos submits FDA application for iDose TR glaucoma implant
