Australian biopharmaceutical company PolyActiva announced it has successfully completed its Phase I clinical study on its lead glaucoma treatment candidate, the Latanoprost FA SR Ocular Implant.
The device was well tolerated in all eight patients with no significant safety findings, reported the company. “The study also showed that the implant persists for the entire six-month treatment period after which the implant biodegrades completely over six weeks. This biodegradation profile should enable repeat dosing with the implant.”
The potential implications of these trial findings for glaucoma sufferers could be huge, said PolyActiva spokesperson Tori Levy, as an estimated 46% of glaucoma patients do not self-administer their eye drops correctly and frequently, which increases the risk of the glaucoma getting progressively worse and potentially leading to blindness. “The implant greatly reduces this risk by effectively removing the need for patients to self-administer treatment.”
The Latanoprost FA SR Ocular Implant is designed to provide a constant daily therapeutic dose of latanoprost-free acid (the active ingredient of a commonly prescribed glaucoma eye-drop, Xalatan) for six months. “Our goal is to improve the reduction of intraocular pressure by ensuring a constant daily dose of drug for the entire treatment period and offering the opportunity for repeated use,” said Russell Tait, CEO of PolyActiva. “Furthermore, the implant should reduce the frequency of conjunctival hyperemia and corneal surface disease side effects often seen with drop therapy.”
PolyActiva has now initiated a Phase II dose ranging study at nine clinical trial sites in Australia to identify the minimum effective dose and confirm the safety of the implant.