The latest announcement about glaucoma treatment study has come recently from a clinical-stage Australian ophthalmology biopharmaceutical company, PolyActiva Pty Ltd. According to the announcement, the company has completed its Phase I clinical study for its lead candidate, the Latanoprost FASR Ocular Implant.
The implant device was well tolerated in all 8 patients without any significant safety findings and 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.
According to the press release, the implant aims to “provide a constant daily therapeutic dose of latanoprost free acid” for 6 months.
The Latanoprost FASR Ocular Implant is designed to substitute for daily drop therapy by providing sustained treatment from a single implant administration over six months to treat glaucoma.
Up to 46 percent of patients do not remember to use their eye drops or administer them poorly. Depending on daily drop therapy is critical to slow the progression of glaucoma, the second most common cause of blindness.
The Latanoprost FASR 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.
The CEO of PolyActiva Russell Tait commented “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 the drug for the entire treatment period and offering the opportunity for repeated use. 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.
PolyActiva is a clinical-stage biopharmaceutical company focused on the development of sustained-release site-specific drug delivery products for ophthalmology. The PolyActiva products currently under development are designed to alleviate daily eye drop therapy for patients.
PolyActiva has two products under development, the Latanoprost FASR Ocular Implant for which a Phase Ib/IIa clinical trial is underway after the successful completion of 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 received venture capital funding from Brandon Capital’s Medical Research Commercialisation Fund (MRCF) and Yuuwa Capital.
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 commercialization 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.
Yuuwa Capital is a $40M early-stage venture capital firm based in Perth, Western Australia. Yuuwa invests in outstanding opportunities where Yuuwa can provide both capital and expertise to help founders, management and early investors build great companies.
Yuuwa invests in early stage companies principally in the areas of Life Sciences and Information and Communications Technology. Yuuwa Capital’s formation in 2009 was supported by private investors and also by the Australian Federal Government’s Innovation Investment Fund program.