PolyActiva Announces First Patient Enrolled in US Phase 2b Clinical Trial of its Ocular Micro Implant for Glaucoma and Ocular Hypertension

FORT WORTH, Texas & MELBOURNE, Australia--(BUSINESS WIRE)--PolyActiva, a clinical-stage biopharmaceutical company pioneering a novel drug delivery technology to improve outcomes for patients with ocular conditions, today announced that the first U.S. patient has been enrolled in the company’s Phase 2b clinical trial evaluating PA5108, an investigational, new chemical entity (NCE), intracameral ocular micro implant, for the reduction in intraocular pressure (IOP) for patients with primary open-angle glaucoma (POAG) and ocular hypertension (OHT).

PA5108, a pro-drug of latanoprost acid, is a rod-shaped, biodegradable micro implant designed to significantly reduce IOP consistently over six months. The implant is engineered using PolyActiva’s PREZIA™ technology platform to provide a constant, zero-order drug release and complete and predictable biodegradation, leaving no residual material in the eye. PA5108 is administered via a single in-office injection into the anterior chamber of the eye using a custom-built delivery device and is being developed to deliver chronic dosing for glaucoma patients.

“The launch of our U.S. Phase 2b study represents a significant milestone in our efforts to address the persistent challenge of daily eye drop compliance in glaucoma care,” said Jerry St. Peter, CEO and Board Director of PolyActiva. “With PA5108, we’re aiming to revolutionize the treatment paradigm by offering a long-acting, biodegradable implant that can be repeat-dosed every six months to deliver long-term, sustained IOP control. We are proud to collaborate with leading investigators, and we are deeply appreciative of the individuals taking part in this study as we work to bring this transformative option to people living with glaucoma.”

The initiation of PolyActiva’s Phase 2b trial in the U.S. comes after the conclusion of a successful Phase 2a trial in Australia, where PA5108 consistently delivered reductions in IOP for six months from a single implant. Further results from the Phase 2a study demonstrated that PA5108 could be repeat-dosed after the initial six months of therapy, providing the opportunity for long-term therapy. Statistically significant IOP changes from baseline were observed for each mean diurnal measurement at weeks 12, 21, 33, and 42. The PA5108 implant to date has been found to be safe and well tolerated by trial participants, with no adverse impact observed on corneal endothelium following repeat dosing of PA5108 and 48 weeks of monitoring.

The Phase 2b study will assess the safety and efficacy of redosing PA5108 for a total of two implants in the study eye. Approximately 75 patients will be enrolled across 12 clinical sites in the U.S., with patients randomized to receive PA5108 at either an 80 mcg or 160 mcg dose in one eye and topical latanoprost in the fellow eye. A control group will also be randomized to receive topical latanoprost in both eyes. Patients will receive a second implant at week 26 after the initial implant. The primary study endpoint is the change in mean diurnal IOP (measured at 8am, 10am, and 4pm) from unmedicated baseline at 12 weeks. Important secondary and exploratory endpoints will assess IOP changes over time in both implants, the safety of both implants, and patient experience. The study will monitor patients for up to 58 weeks, with the results informing dose strength and dosing frequency for a planned Phase 3 registration trial.

“Poor adherence to daily eye drops continues to be one of the most significant challenges in glaucoma care,” said Jason Bacharach, M.D., Director of Research at North Bay Eye Associates, Petaluma, Calif., and a key investigator in the study. “A sustained, biodegradable implant like PA5108 that can be reimplanted for chronic dosing would provide a transformative alternative for patients and clinicians alike.”

About PREZIA™

PolyActiva’s proprietary PREZIA™ drug delivery platform underpins PA5108 and other candidates in the company’s pipeline. Unlike traditional polymer matrix or nanoparticle-based systems that rely on passive diffusion, PREZIA uses covalent bonding to attach therapeutic agents to a polymer backbone. This approach enables precise, consistent, and fully customizable drug release over periods ranging from one week to over one year. The platform’s biodegradable design eliminates residual buildup and supports repeat dosing. PREZIA-based therapies can be formulated as rod-shaped implants or injectable gels and are compatible with both single-agent and combination therapies for a broad range of ocular conditions. The PREZIA technology is unique in that it allows for new patent protection over existing drugs when delivered with this platform.

About PolyActiva

PolyActiva is a clinical-stage biopharmaceutical company developing novel drug delivery solutions to improve outcomes for patients with ocular conditions. The company’s lead asset,

PA5108, a new chemical entity (NCE), is an investigational intracameral ocular micro implant, that delivers sustained latanoprost pro-drug therapy, to reduce intraocular pressure (IOP) for patients with primary open-angle glaucoma (POAG) and ocular hypertension (OHT). For more information, visit polyactiva.com.