PolyActiva completes recruitment in key Phase I glaucoma implant safety study.
July 23, 2019
PolyActiva Pty Ltd, a clinical-stage biotechnology company and leader in ocular drug delivery, has completed patient enrolment for its Phase I clinical trial to study safety and tolerability of its biodegradable, slow-release ocular implant for the treatment of glaucoma.
PolyActiva’s implant has the potential to revolutionise the treatment for millions of glaucoma patients. Current glaucoma treatment requires eye drops to be administered daily, often multiple times each day. Instead the revolutionary implant delivers the medication to the eye for at least 30-weeks without the patient needing to administer drops, and then biodegrades completely, leaving no residue.
Compliance is a major problem globally for patients with glaucoma, with studies showing up to 46 per cent of patients forget to use their drops or administer them poorly. Failure to adhere to treatment leads to faster progression of glaucoma, the second leading cause of blindness.
“The PolyActiva implant is an exciting advance in glaucoma treatment. It is simple to administer, is well received by patients and ensures the glaucoma medication is delivered to the eye continuously, each and every day”, says Dr Nathan Kerr, Principal Investigator for the Phase I study.
“To date, our Phase I study has demonstrated that our implant is safe and well tolerated and provides treatment for a six-month period before it biodegrades completely. We have achieved a major step forward in the advance of ocular implants developing the first implant to completely disappear within 6 weeks of the completion of treatment” says PolyActiva CEO Dr Russell Tait. “With recruitment now closed, top-line safety and initial efficacy data from this study will be available by the end of this calendar year.”
PolyActiva further announced that it has closed an AU$10m (US$7m) capital raise. The new capital will be used to fund the next clinical studyto identify the efficacious dose for the glaucoma implant. Funds will also support the first clinical study with the company’s second asset, an ocular implant to prevent endophthalmitis (ocular infection) following cataract surgery. Recruitment for both studies will commence in October 2019. The additional capital has been provided by existing shareholders and associates, including Australian-based investors the Medical Research Commercialisation Fund, managed by Brandon Capital Partners, and Yuuwa Capital.
“Our latest investment will speed the treatment’s development so that we can have it available for patients as soon as possible,” says Dr Chris Nave, Chairman of PolyActiva and CEO of the Medical Research Commercialisation Fund (MRCF).
The innovative drug delivery technology that underpins PolyActiva’s two clinical assets has further potential applications, including being used to administer other types of medication to the eye.
The glaucoma implant,Latanoprost FA SR Ocular Implant,is designed to provide a constant daily therapeutic dose of latanoprost free acid for at least 30 weeks. Latanoprost is the active ingredient of a commonly prescribed glaucoma eye-drop treatment (Xalatan®), a product with peak sales of $US1.7bn. The implant is easily administered to the eye in an ophthalmologist’s office under a slit-lamp using a custom-designed administration device.
Initial data on the Phase I clinical trial, conducted at the Centre of Eye Research Australia (CERA), is expected to be released in January 2020.
Laura E. Dreer, Christopher Girkin and Steven L. Mansberger. Determinants of Medication Adherence to Topical Glaucoma Therapy. J Glaucoma. 2012 Apr; 21(4): 234–240.