Clinical Trial Begins For PolyActiva Biodegradable Glaucoma Implant
PolyActiva Pty Ltd, a clinical-stage Australian biotechnology company, has recently received USD$12million in venture capital to fund its Phase 1 clinical study designed to show its PA5108 glaucoma implant is safe and well tolerated.[1]
PolyActiva has used its proprietary ‘polymer prodrug technology’ to develop Prostaglandin ocular implant that, when placed in the eye, provide sustained release of medication for at least 6-months. The implant is designed to biodegrade as soon as possible within 90 days after the treatment period, leaving no residue or non-toxic by-products.
The rod-shaped ocular implant is administered intracamerally by clear corneal injection into the anterior chamber of the eye with an injector fitted with a 27G needle. This glaucoma implant is intended to substitute for daily drop therapy of latanoprost free acid (the active agent of latanoprost).
“The major investors, Brandon Capital Partners’ MRCF and Yuuwa Capital, see this technology having a major potential impact on the lives of millions of glaucoma patients globally,” says Dr Chris Nave, Chairman of PolyActiva and CEO of the Medical Research Commercialisation Fund (MRCF). “This innovative drug delivery technology has further potential applications, such as being used to administer other types of medication, including antibiotics and steroids for cataract surgery patients.”
Better Adherence on Glaucoma Medical Therapy
Glaucoma is the second leading cause of glaucoma is the second leading cause of blindness in developed countries, affecting more than 2.7 million Americans over age 40. That number is estimated to more than double by 2050.[2]
The emphasis of research and development for glaucoma medical therapy is on reducing the burden of eye drops on patients in hopes of better controlling disease progression by lowering the percentage of non-adherence to the prescribed therapy. Failure to adhere
to treatment can lead to faster progression of glaucoma, one of the most common causes of blindness. “This product is designed to make the lives of glaucoma sufferers easier by removing the need for daily drop administration and thus improving treatment management,” says PolyActiva CEO Dr Russell Tait.
The revolutionary technology could in the future mean millions of people with open-angle glaucoma no longer need to use daily eye drops. The potential of removing the reliance on the patient to remember to use eye drops, and the associated difficulty in administering them from the paradigm of glaucoma treatment, is being heralded as major potential health breakthrough by ophthalmologists.
Phase 1 Clinical Trial of PolyActiva PA5108 Ocular Implant
The Phase I clinical trial will see seven glaucoma patients enrolled to evaluate the safety and tolerability of its PA5108 ocular implant. Participants who are currently managing their Open Angle Glaucoma with combination drop therapy will be recruited. Drop therapy will cease in the treatment eye and continue in the contralateral eye. The treated eye will receive via injection, a single PA5108 ocular implant. Participants will be monitored for safety and tolerability of the ocular implant until it completely biodegrades.[3] Initial results are expected in Q1 2019. If it succeeds PolyActiva will further conduct a phase one B-trial involving 20 patients to determine optimal dose.
The clinical trial is being conducted under the Therapeutic Goods Administration Clinical Trial Notification (CTN) scheme at the Royal Victorian Eye and Ear Hospital in Melbourne, Australia, through the Centre of Eye Research Australia (CERA).
References:
- WIRE B. PolyActiva Commences Its First Phase I Clinical Trial with Potential to Improve Daily Lives of Millions of Glaucoma Patients [Internet]. Businesswire.com. 2018 [cited 2018 Sep 10]. Available from: https://www.businesswire.com/news/home/20180830005869/en/PolyActiva-Commences-Phase-Clinical-Trial-Potential-Improve
- 10 things you should know about glaucoma | National Eye Institute [Internet]. Nei.nih.gov. 2018 [cited 2018 Sep 10]. Available from: https://nei.nih.gov/content/10-things-you-should-know-about-glaucoma
- Safety and Tolerability of a Prostaglandin Ocular Implant for Treatment of Open Angle Glaucoma – Full Text View – ClinicalTrials.gov [Internet]. Clinicaltrials.gov. 2018 [cited 2018 Sep 10]. Available from: https://clinicaltrials.gov/ct2/show/NCT03604328
