Qlaris Bio Advances Development of Fixed-Dose Combination Therapy for Glaucoma

Qlaris Bio has announced the development of a novel, preservative-free fixed-dose combination therapy (QLS-111-FDC) that unites its lead investigational agent QLS-111 with latanoprost, a cornerstone treatment in glaucoma care. The therapy is being designed for patients with primary open-angle glaucoma (POAG), ocular hypertension (OHT), and normal tension glaucoma (NTG), particularly those who remain inadequately controlled due to the need to reduce episcleral venous pressure (EVP), a component of intraocular pressure (IOP) not addressed by current therapies.

Targeting the Unmet Need: Lowering Episcleral Venous Pressure

QLS-111 is a first-in-class ATP-sensitive potassium channel modulator that lowers IOP by selectively reducing EVP. According to Qlaris Bio, EVP remains the only modifiable component of IOP not targeted by existing FDA-approved treatments.

Latanoprost, a prostaglandin analogue, reduces IOP by increasing uveoscleral outflow, making it a well-established standard of care in glaucoma management. QLS-111-FDC combines both mechanisms to provide a complementary dual-action approach to IOP reduction.

Phase 2 Clinical Data Supports Efficacy and Safety

Findings from Qlaris Bio’s Phase 2 Apteryx study—which included patients with POAG and OHT—demonstrated that QLS-111, when added to latanoprost monotherapy, produced an additional IOP reduction of over 3 mmHg compared to latanoprost alone. Notably, this enhanced efficacy was achieved without causing additional hyperemia or other clinically meaningful adverse events.

These results support the potential of QLS-111-FDC to deliver superior IOP control while maintaining favorable safety and tolerability, crucial factors for long-term patient adherence and treatment success.

Clinical Perspective on Treatment Simplification

Dr. Barbara Wirostko, MD, FARVO, Chief Medical Officer of Qlaris Bio, emphasized the clinical significance of the fixed-dose approach:

“Patients who remain uncontrolled on monotherapy often face challenges with multi-drug therapy, which can negatively impact adherence and outcomes. A fixed-dose combination simplifies treatment regimens and, with the strong safety and additive efficacy profile of QLS-111, may offer an important option for patients requiring further IOP lowering. Importantly, the recently completed phase 2 studies show that QLS-111 does not cause additional hyperemia, which will be important for patient compliance.”