Primary and secondary efficacy endpoints achieved, statistical demonstration
Significant reduction in intraocular pressure (IOP) for patients with glaucoma
Melbourne, Australia, February 17, 2022 /PRNewswire/ — PolyActiva Pty Ltd, an Australian clinical-stage biopharmaceutical company focused on developing unique biodegradable eye implants with prolonged drug delivery for patients with ophthalmic diseases such as glaucoma, today announced that the Phase IIa study of its Ocular implant PA5108 for the treatment of primary open-angle glaucoma (POAG) met the study’s primary and secondary efficacy endpoints of at least 20% reduction in IOP in its low-dose cohort. The results of the study were presented by Russell TaitPhD, CEO of PolyActiva, at 11and Annual Glaucoma 360 New Horizons Forum at San FranciscoCALIFORNIA.
Primary efficacy endpoints achieved, demonstrating a statistically significant reduction in IOP in patients with glaucoma
“The results from the low-dose cohort demonstrate that the implant achieves a clinically significant IOP-lowering effect,” commented the Associate Professor. Michel Coute, MD, senior glaucoma specialist at Melbourne Eye Specialists and principal investigator of the study. “The PA5108 ocular implant with Prezia Sustained Drug Delivery technology may provide a significant advance in the treatment of glaucoma with the laudable goal of enabling a consistent dose of medication for six months via a safe and effective biodegradable implant.”
The Phase IIa open-label multicenter study was designed to evaluate the minimum effective dose of the PA5108 ocular implant in patients with mild to moderate POAG in 3 dose cohorts (10 subjects per cohort). Primary and secondary efficacy endpoints include mean daytime IOP at 12 and 26 weeks compared to baseline, and 8am IOP at 6, 18 and 21 weeks compared to baseline.
First results of the phase IIa trial in a low-dose cohort:
Statistically significant reduction in IOP from baseline of >20% IOP lowering effect (p
Statistically significant and clinically meaningful mean change in diurnal IOP at 12 and 26 weeks (p
Persistence of the implant for at least 21 weeks with complete biodegradation of the implant at week 40, over a period of 4 to 6 weeks.
The low-dose implant was found to be generally well tolerated, with no serious ocular adverse product-related effects, no endothelial cell loss, and no implant movement.
“When providing treatment to my glaucoma patients, I look for effective IOP lowering solutions that improve compliance with medical treatment. An implant that allows for a repeat dose of treatment with a consistent daily release of medication at a low dose for 20 weeks and is fully biodegradable while being well tolerated is highly desirable,” said ike ahmedMD, FRCSC, ophthalmologist at the Prism Eye Institute of Ontario, Canadaassistant professor at the University of Torontoand clinical professor at the University of Utah. “These data demonstrate that the PA5108 ocular implant with Prezia technology delivers on the promise of providing a target profile that allows me to better manage the progression of glaucoma for patients in my clinical practice.”
“We are delighted to announce these positive Phase IIa results, as they underscore the significant benefits that the PA5108 ocular implant with Prezia technology can bring to the ophthalmology community and to patients suffering from the effects of glaucoma,” said Russell Tait. “We look forward to further exploring its beneficial clinical impact as we move into the next phase of our clinical program.”
The PA5108 ocular implant utilizes patented Prezia™ Sustained Drug Delivery Technology to deliver a consistent daily dose of latanoprost free acid and is designed to include attributes not achievable by conventional blend technologies, including: zero order and rapid, complete and non-toxic biodegradation shortly after processing is complete. Prezia technology is versatile, can be used to deliver multiple drugs in a single implant, and is suitable for delivery to the front and back of the eye.
PolyActiva is an innovative clinical-stage ophthalmology company with proprietary polymeric prodrug technology that enables specific, precise and controlled drug delivery to the eye. The company is committed to becoming a leader in ophthalmic medicine by providing unique biodegradable implants with sustained drug delivery to improve patient outcomes and quality of life.
PolyActiva has two products in development, the first is the Latanoprost FA SR ocular implant for which a Phase Ib/IIa clinical trial is underway following the successful completion of a Phase I clinical trial for the treatment of Angled Glaucoma open. The second product is Levofloxacin SR eye implant, an antibiotic-based eye implant, developed as a treatment to reduce the risk of infection after cataract surgery. PolyActiva is based in Melbourne, Australiaand secured venture capital funding from the Medical Research Commercialization Fund (MRCF) of Brandon Capital and Yuuwa Capital.
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