New clinical data from Polyactiva’s Phase 2 clinical trial (LATA-CS102) demonstrates that its novel glaucoma treatment technology, PA5108, met its efficacy and safety endpoints. The company said this represents a significant step forward in its vision to provide long-term, reliable drug delivery for glaucoma patients.
PA5108 is an implant, constructed from a biodegradable polymer and designed for sustained drug delivery. Unlike other treatments on the market, PolyActiva’s implant rapidly degrades once the drug is released, allowing for repeat dosing.
Data from the trial was presented in October at the Eyecelerator Conference in conjunction with the American Academy of Ophthalmology Conference in Chicago and at AusBiotechInvest.1
PolyActiva’s proprietary implant is designed to address the long-standing challenge of poor patient adherence with traditional eye drop therapy
Seventeen participants were recruited to receive two PA5108 ocular implants, 21 weeks apart and at the time of the data being released, 15 participants had reached 48 weeks on the study. PolyActiva reported:
- Statistically significant intraocular pressure (IOP) changes from baseline for each mean diurnal measurement at weeks 12, 21, 33, and 42 (p<0.0001),
- Clinically meaningful IOP reductions at 8am over 48 weeks, 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. 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,” said Vanessa Waddell, PolyActiva CEO.
PolyActiva has developed proprietary manufacturing processes and Ms Waddell said the company was on track to achieve commerical scale.
On the back of these promising results PolyActiva is preparing for a Phase 2b clinical trial of PA5108.
Reference
- PolyActive, PolyActiva showcases promising clinical data highlighting its polymer technology’s potential to transform glaucoma care (news release, 30 Oct 2024), available at: polyactiva.com/wp-content/uploads/2024/10/PolyActiva-Eyecelerator-Press-Release_FINAL.pdf [accessed Nov 2024].
