PolyActiva's PA5108 Implant Shows Promise

PolyActiva has announced encouraging results from its Phase 2 clinical trial for the PA5108 glaucoma implant, a groundbreaking approach to long-term drug delivery for glaucoma patients. The trial successfully met key efficacy and safety endpoints, demonstrating significant reductions in intraocular pressure (IOP) over 26 weeks.

Advancing Glaucoma Treatment

The PA5108 implant is designed to address poor adherence to traditional eye drop therapy by delivering consistent, sustained doses of medication. Its biodegradable polymer construction ensures no residue remains after the drug is fully delivered, allowing for repeat dosing.

Michael Coote, MBBS, FRANZCO, GAICD, clinical professor at the University of Melbourne, highlighted the implant’s benefits:

• Delivers latanoprost with zero-order kinetics for 26 weeks.

• Inserted into the anterior chamber using a simple delivery device.

• Dissolves completely after drug delivery, leaving no trace in the eye.

Key Findings from the Phase 2 Clinical Trial

The trial included 17 participants, with 15 completing 48 weeks of treatment. Participants received two PA5108 implants, spaced 21 weeks apart.

Efficacy Results

• Greater than 20% IOP reduction based on 8 AM and mean diurnal readings over the study period.

• Patients receiving a second implant showed sustained IOP reductions for an additional 26 weeks, with clinically significant tail effects.

Safety Profile

• No evidence of inflammation or corneal endothelial cell changes.

• Minimal adverse effects from implant administration.

• One patient required rescue medication for IOP elevation in both eyes, unrelated to the implant.

Professor Coote emphasized that the implant eliminates the variability of self-administered eye drops, improving consistency in glaucoma management.

Addressing Long-Standing Challenges

The PA5108 implant offers solutions to common issues faced by glaucoma patients:

1. Prostaglandin Orbitopathy

Unlike topical drops, the implant minimizes prostaglandin exposure to periorbital tissues, reducing the risk of prostaglandin-associated adverse effects.

2. Ocular Surface Disease

The implant bypasses the ocular surface entirely, reducing irritation, dryness, and discomfort commonly caused by eye drops.

Future Development Plans

PolyActiva is preparing for a Phase 2b clinical trial in 75 patients, marking the product’s first U.S. study. Additionally, a second-generation implant offering 12 months of treatment will enter clinical trials in Australia in 2025.

Vanessa Waddell, CEO of PolyActiva, noted:

• The Phase 3 trial is expected to take approximately 2.5 years, with commercialization targeted by 2029.

• PolyActiva aims to address the adherence challenge, as studies indicate that 40% to 90% of patients discontinue correct use of eye drops within a year.

Transforming Glaucoma Care

With 80 million glaucoma patients worldwide, the demand for improved treatments is immense. PolyActiva’s innovative PA5108 implant represents a significant step forward in:

• Long-term, reliable drug delivery.

• Reducing the burden of daily adherence.

• Enhancing patient outcomes.

PolyActiva is committed to advancing glaucoma care with its cutting-edge solutions, setting the stage for a transformative future in ophthalmology.