PolyActiva Begins U.S. Phase 2b Glaucoma Implant Trial

PolyActiva has enrolled the first U.S. patient in its Phase 2b clinical trial evaluating PA5108, a novel intracameral, biodegradable micro implant designed to deliver sustained intraocular pressure (IOP) reduction in patients with primary open-angle glaucoma (POAG) and ocular hypertension (OHT).

Long-Acting Glaucoma Therapy with PREZIA Technology

PA5108 is a new chemical entity (NCE) and pro-drug of latanoprost acid, engineered to provide consistent IOP-lowering therapy for up to six months following a single in-office injection. Delivered directly into the anterior chamber, the rod-shaped implant incorporates PolyActiva’s proprietary PREZIA technology platform, which enables:

• Zero-order drug release for consistent and linear delivery over time

• Predictable and complete biodegradation with no residual material left in the eye

• Repeat-dosing capability for long-term 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 six months to deliver long-term, sustained IOP control.”

Progressing to Phase 2b Following Positive Phase 2a Outcomes

The U.S. trial builds upon encouraging results from an earlier Phase 2a study conducted in Australia, which demonstrated that a single dose of PA5108 reduced IOP consistently for six months, with safe and effective repeat dosing at the six-month mark. Statistically significant IOP reductions were maintained at weeks 12, 21, 33, and 42. The implant was well tolerated over 48 weeks of monitoring, with no adverse effects on the corneal endothelium, even with sequential dosing.

Phase 2b Trial Design and Objectives

The 58-week U.S. Phase 2b study will evaluate the safety, efficacy, and patient experience of repeat PA5108 dosing, enrolling a total of 75 patients across 12 clinical sites. Participants will be randomized to receive PA5108 at either 80 mcg or 160 mcg in one eye with topical latanoprost administered in the fellow eye, or to receive topical latanoprost in both eyes as a control.

At Week 26, patients will receive a second PA5108 implant in the study eye.

Primary Endpoint

The primary endpoint of the trial is the change in mean diurnal intraocular pressure (IOP), measured at 8 a.m., 10 a.m., and 4 p.m., from the unmedicated baseline at 12 weeks.

Secondary and Exploratory Endpoints

Secondary and exploratory endpoints include evaluating IOP changes over time for both implants, assessing the safety and tolerability of sequential implants, and analyzing patient-reported outcomes along with overall treatment experience.

The data from this trial will be used to determine the optimal dose strength and dosing frequency for an upcoming Phase 3 registration study aimed at bringing this innovative therapy to market.