PolyActiva Pty Ltd, a clinical-stage Australian ophthalmology biopharmaceutical company, announced it has successfully completed its Phase I clinical study for its lead candidate, the Latanoprost FA SR Ocular Implant.
The device was well tolerated in all 8 patients with no significant safety findings. The study also showed that the implant persists for the entire 6-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 drop therapy by providing sustained treatment from a single implant administration over a six-month period to treat glaucoma.
Up to 46 percent of patients do not remember to use their eye drops or administer them poorly. Adherence to daily 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 6-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.
More than three million Americans live with glaucoma. 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.
Robin et al American J. Ophthalmol. (2007) 144(4):533-40
About PolyActiva Pty Ltd
PolyActiva is a clinical-stage biopharmaceutical company focused on the development of sustained release site-specific drug delivery products for ophthalmology. The products currently under development are designed to alleviate daily eye drop therapy for patients. The company has two products under development, the Latanoprost FA SR Ocular Implant for which a Phase Ib/IIa clinical trial is underway after the successful completion of a Phase I clinical trials for the treatment of open angle glaucoma. The second is a Levofloxacin SR Ocular Implant, an antibiotic-based ocular implant, being developed as a treatment to reduce the risk of infection after cataract surgery. A Phase Ia clinical study will commence in November 2020. PolyActiva is based in Melbourne, Australia, and has secured venture capital funding from Brandon Capital's Medical Research Commercialisation Fund (MRCF) and Yuuwa Capital.
About the Medical Research Commercialisation Fund (MRCF) and Brandon Capital Partners
Brandon Capital Partners is a venture capital firm that manages the Medical Research Commercialisation Fund (MRCF), Australia and New Zealand's largest life science investment fund, with over AU$680 million under management. The MRCF is a unique collaboration between major Australian superannuation funds, the Australian and New Zealand governments, Australian state governments and more than 50 leading medical research institutes and research hospitals. The MRCF supports the development and commercialisation of early-stage biomedical discoveries originating from member research organisations, providing both capital and expertise to guide the successful development of new therapies. The MRCF has supported more than 40 start-up companies to date, 34 of which were founded by the MRCF.
About Yuuwa ...
(All Rights Reserved)