Glaucoma is the second leading cause of blindness worldwide, affecting an estimated 70 million individuals. It affects 1 in 200 people aged fifty and younger, and 1 in 10 over the age of eighty. Glaucoma is associated with increased pressure of the fluid in the aqueous humour. This pressure can be lowered with medication, usually eye drops. However, poor compliance with medications and follow-up visits is a major reason for vision loss in glaucoma patients. On average, patients with chronic asymptomatic medical conditions take from 30% to 70% of their prescribed medication and 50% discontinue medications in the first months of therapy.
To overcome these challenges, PolyActiva has engineered an ocular implant for the treatment of glaucoma that substitutes for daily drop therapy. The implant is administered intracamerally by clear corneal injection into the anterior chamber of the eye with a bespoke administration device fitted with a 27G needle. The rod-shaped ocular implant fits in the lumen of the 27G needle. It starts to deliver a constant daily dose of latanoprost free acid (the active agent of latanoprost) for a period of at least 6-months, starting from the first day after administration. The implant is designed to biodegrade as soon as possible after the treatment period and biodegrades into safe and non-toxic by-products, leaving no residue. The implant comprises a single biomaterial (latanoprost free acid polymeric prodrug) engineered from PolyActiva’s polytriazole hydrogel system.
PolyActiva has studied the performance (both efficacy and safety) of its latanoprost ocular implant in purpose-bred, homozygous for the G661R missense mutation in ADAMTS10, and therefore affected with POAG (Kuchtey et. al., 2011, PLoS Genet, 7). Implants have been produced to provide treatment periods of 10, 20, 30 and 50 weeks. PolyActiva’s latanoprost ocular implant is currently being evaluated in a phase Ib clinical trial in 30-40 participants in Australia. The study is designed to determine a safe and efficacious dose of latanoprost. The company concluded a phase Ia safety study in Q2 2020 demonstrating that the product is safe.
PolyActiva has initiated preclinical work towards development of a timolol ocular implant also for the treatment of glaucoma.
PolyActiva has developed a bespoke administration device that enables administration of the these implants by clear corneal injection into the anterior chamber or trans-scleral injection into the vitreous chamber of the eye through a straight 27G needle with a bevelled tip. The administration device is ergonomically designed for either left or right-handed administration and is operated similarly to a conventional syringe.