A Victorian biopharmaceutical company has reported positive results from a Phase 1 study examining the safety of its biodegradable implant for glaucoma.
PolyActiva announced on 5 November that its lead candidate, the Latanoprost FA SR Ocular Implant, was well tolerated in all eight patients with no significant safety findings.
The study also showed the implant persists for the six-month treatment period after which it biodegrades completely over six weeks. This biodegradation profile should enable repeat dosing with the implant, the clinical-stage company stated.
The implant is designed to provide a constant daily therapeutic dose of latanoprost free acid – the active ingredient of 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.
According to the company, up to 46% of patients do not remember to use their eye drops or administer them poorly.
“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.” Dr Russell Tait, CEO of PolyActiva, said.
“Furthermore, the implant should reduce the frequency of conjunctival hyperemia and corneal surface disease side effects often seen with drop therapy.”
PolyActiva has now started a Phase 2 dose ranging study at nine clinical trial sites in Australia. The study will aim to identify the minimum effective dose of latanoprost free acid and confirm the safety of the implant.
PolyActiva is based in Melbourne, having received venture capital funding from Brandon Capital’s Medical Research Commercialisation Fund (MRCF) and Yuuwa Capital.
It is also developing a levofloxacin ocular implant for prevention of endophthalmitis following ocular surgery, and in January received a Medical Research Future Fund grant for a sustained release ocular implant that delivers steroids and non-steroidal anti-inflammatory medications for macular oedema.