PolyActiva Initiates US Phase 2b Clinical Trial of PA5108 Biodegradable Ocular Implant for Glaucoma and OHT

PolyActiva announced the enrollment of the first US patient in its phase 2b clinical trial evaluating PA5108, a novel intracameral, biodegradable micro implant designed to provide sustained IOP reduction in patients with primary open-angle glaucoma (POAG) and ocular hypertension (OHT).

PA5108 is a new chemical entity (NCE) and prodrug of latanoprost acid engineered to deliver consistent IOP-lowering therapy over a 6-month period following a single in-office injection. Administered directly into the anterior chamber, the rod-shaped implant utilizes PolyActiva’s proprietary PREZIA technology platform, which enables zero-order drug release (consistent and linear delivery over time), predictable and complete biodegradation, leaving no residual material in the eye, and repeat-dosing capability for chronic disease management.

“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 6 months to deliver long-term, sustained IOP control.”

The Phase 2b trial builds on encouraging outcomes from a prior phase 2a study conducted in Australia, which demonstrated that:

• A single dose of PA5108 consistently reduced IOP for 6 months

• Repeat dosing at 6 months was safe and effective

• Statistically significant IOP reductions were sustained at weeks 12, 21, 33, and 42

• The implant was well tolerated over 48 weeks of monitoring, with no adverse effects on corneal endothelium, even with repeat dosing

Phase 2b Trial Design

The U.S. phase 2b study will evaluate safety, efficacy, and patient experience with repeat dosing of PA5108 over 58 weeks. Key aspects of the trial include:

• 75 patients enrolled across 12 U.S. clinical sites

• Randomization to receive PA5108 at either 80 mcg or 160 mcg in one eye and topical latanoprost in the fellow eye

• A control group receiving topical latanoprost bilaterally

• Redosing at Week 26, with a second PA5108 implant in the study eye

Primary Endpoint

• Change in mean diurnal IOP (measured at 8 a.m., 10 a.m., and 4 p.m.) from unmedicated baseline at 12 weeks.

Secondary and Exploratory Endpoints

• IOP changes over time for both implants

• Safety and tolerability of sequential implants

• Patient-reported outcomes and treatment experience

The data from this trial will be pivotal in determining dose strength and dosing frequency for an upcoming Phase 3 registration study.