PolyActiva has enrolled the first US patient in a phase 2b clinical trial of PA5108, an experimental intracameral implant designed to lower intraocular pressure (IOP) in people with primary open-angle glaucoma and ocular hypertension.

PA5108 is a biodegradable, rod-shaped microimplant that delivers a prodrug of latanoprost acid for up to 6 months. Using the company’s proprietary Prezia technology, the device releases the drug at a constant rate and degrades completely without leaving residue in the eye. It is inserted during an in-office procedure into the anterior chamber with a custom device.

The US trial follows a phase 2a study in Australia in which the implant lowered IOP for 6 months from a single administration and maintained safety over repeat dosing. The current study will enroll about 75 patients at 12 sites. Participants will be randomized to receive either 80 µg or 160 µg of PA5108 in one eye, with topical latanoprost in the other, or topical latanoprost in both eyes. A second implant will be given at 26 weeks, and patients will be followed for up to 58 weeks.

The primary endpoint is change in mean diurnal IOP at 12 weeks from an unmedicated baseline. Results are expected to inform dosing for a planned phase 3 trial. GP