A small Phase I clinical study for an ocular implant to treat glaucoma, by lowering intraocular pressure, has been successfully completed by the Melbourne-based biopharmaceutical company PolyActiva Pty Ltd.
The product – Latanoprost FA SR Ocular Implant – was well tolerated across the study population. The study showed that the implant retained its position in the eye and delivered a constant daily therapeutic dose of latanoprost free acid (the active ingredient of the commonly prescribed glaucoma eye-drop, Xalatan) for the entire six-month treatment period.
Most importantly, the implant retained its original structure for 26 weeks before completely degrading over six weeks, leaving no residue by week 32.
Having completed the Phase 1 study, Dr Russell Tait, CEO of PolyActiva, said the findings were exciting.
“It’s been particularly challenging to complete the study under COVID-19 restrictions, but the recent data has motivated us to move forward. There is no other ocular implant that can deliver a guaranteed daily therapeutic dose over six months, with no change to the dosage, then completely degrade at week 32 leaving no residue. This opens the door for a repeat dose therapy.”
A slow release implant would help overcome the significant problem of treatment noncompliance – up to 46% of glaucoma patients do not remember to use their eye drops or they administer them poorly. As well as providing ophthalmologists with a guarantee that their patients are receiving effective treatment to lower intraocular pressure, the implant should reduce the frequency of conjunctival hyperemia and corneal surface disease side effects often seen with drop therapy.
Importantly in busy clinics, the implant is easy to administer via injection into the clear cornea in an ophthalmologist’s rooms, taking just 20 seconds.
PolyActiva has now initiated a Phase II study at nine clinical trial sites in Australia to determine the minimum effective dose that can be administered over 32 weeks, and to confirm the safety of the implant.