Eight patients were able to receive a second implant at 21 weeks, with no product related adverse effects.
PolyActiva, a Melbourne-based ophthalmology company, reported promising interim results from an ongoing Phase 2a clinical study for its PA5108 Ocular Implant in subjects with mild to moderate glaucoma.
In a press release sent to Ophthalmology Times, PolyActiva described the PA5108 ocular implant as “[an] implant designed to deliver 6 months of latanoprost and to biodegrade, allowing for repeat dosing.”
The company stated PA5108 showed a >20% reduction in intraocular pressure (IOP) at 12 weeks and 26 weeks. In a further cohort, the implant’s rapid biodegradation profile also allowed for 8 patients to receive a second implant at 21 weeks, with no product related adverse effects.
Vanessa Waddell, CEO of PolyActiva, discussed the implant in the release saying, “For ocular implants to ultimately replace daily eye drops for the treatment of glaucoma, they need to be suitable for repeat administration, which has been a principal goal of PolyActiva’s development program. Our Phase 2a results indicate we are well placed to meet that objective.”
Eye drops have been a cornerstone in glaucoma treatment, however, 41-90% of patients do not correctly administer their drops after one year.
“Sustained drug delivery via an implant could reduce the reliance on daily eye drops and ensure that the correct amount of medicine is delivered consistently, every day,” Waddell said. “The implants received by these trial participants were present for 26 weeks before they biodegraded, which gives us confidence that our technology will be able to deliver a long-term treatment option for glaucoma patients. We look forward to continuing our development of this product as we plan for confirmatory trials in the US.”
PolyActiva presented its interim phase 2 data at the Eyecelerator Ophthalmic Innovation Conference in San Francisco on November 2nd. The company plans to initiate its Phase IIb clinical trial in the US, Australia, and New Zealand in 2024.