A Phase I clinical study for an ocular implant to treat glaucoma has been successfully completed by PolyActiva Pty Ltd, a clinical-stage Australian ophthalmology biopharmaceutical company.
The device – Latanoprost FA SR Ocular Implant – was well tolerated in all eight patients with no significant safety findings. 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 Latanoprost FA SR Ocular Implant is designed to substitute for daily eye drop therapy by providing sustained treatment
The Latanoprost FA SR Ocular Implant is designed to substitute for daily eye drop therapy by providing sustained treatment from a single implant administration over a six-month period to treat glaucoma.
Up to 46% of patients do not remember to use their eye drops or administer them poorly. Adherence to daily eye drop therapy is critical to slow progression of glaucoma, the second most common cause of blindness.1
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. It is administered in a simple procedure at an ophthalmologist’s office using PolyActiva’s bespoke administration device.
“Our implant represents a significant advance for the treatment of glaucoma. Our goal is to improve the reduction of intraocular pressure (IOP) by ensuring a constant daily dose of drug for the entire treatment period and offering the opportunity for repeated use.” says 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. The study is designed to identify the minimum effective dose of latanoprost free acid and confirm the safety of the implant.
In 2020, about 80 million people have glaucoma worldwide, and this number is expected to increase to over 111 million by 2040.
PolyActiva is based in Melbourne, Australia, having received venture capital funding from Brandon Capital’s Medical Research Commercialisation Fund (MRCF) and Yuuwa Capital.
Reference
1. Robin et al American J. Ophthalmol. (2007) 144(4):533-40
