Qlaris Bio Announces Development of Fixed-Dose Combination Therapy with QLS‑111 and Latanoprost for the Treatment of Glaucoma

Combination therapy seeks to improve intraocular pressure lowering by pairing a novel EVP-targeting agent with prostaglandin analogue standard of care

DEDHAM, Mass.--(BUSINESS WIRE)--Qlaris Bio, Inc., a clinical-stage biotechnology company, today announced that it is developing a novel preservative-free, fixed-dose combination (FDC) therapy that combines the company’s lead program, QLS-111, and latanoprost, the most commonly prescribed prostaglandin analogue for the treatment of glaucoma. The QLS-111 and latanoprost fixed-dose combination (QLS-111-FDC) is being developed as a treatment for patients with primary open angle glaucoma (POAG), ocular hypertension (OHT), and normal tension glaucoma (NTG) for whom optimal intraocular pressure (IOP) control may remain unachievable due to the need to lower episcleral venous pressure (EVP). EVP, which is the target of QLS-111, remains the only component of IOP that is not addressed by currently approved treatments.

QLS-111 utilizes a first-in-class ATP-sensitive potassium channel modulator designed to lower IOP by selectively reducing EVP, which may represent the largest component of IOP in patients. Latanoprost, a gold standard in glaucoma care, lowers IOP by increasing uveoscleral outflow. Together, the agents offer a complementary dual mechanism approach aimed to further enhance IOP control. Reduction of IOP remains the only modifiable risk factor shown to slow the progression to blindness in patients with glaucoma.

Data from Qlaris Bio’s Phase 2 study in POAG and OHT patients, the Apteryx study, demonstrated that QLS-111, when administered in addition to latanoprost monotherapy, achieved over 3 mmHg of additional IOP reduction compared to latanoprost monotherapy alone. Importantly, this additive efficacy was achieved without additional hyperemia or other clinically meaningful adverse events, supporting the potential of QLS-111-FDC to provide improved IOP control without compromising safety or tolerability.

“Patients who remain uncontrolled on monotherapy often face challenges with multi-drug therapy, which can negatively impact adherence and outcomes,” said Barbara Wirostko, MD, FARVO, Chief Medical Officer of Qlaris Bio. “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.”

“Combining QLS-111 with latanoprost in a preservative-free fixed-dose combination is a very promising and exciting advancement,” said Alex Huang, MD, PhD, Associate Professor at the Shiley Eye Institute at UC San Diego Health. “This approach targets two distinct and complementary mechanisms and could offer improved IOP control in a single topical eyedrop—something that aligns well with real-world needs of patients surrounding compliance and long-term IOP control. Targeting the reduction of EVP and distal outflow to lower IOP represents a fundamental shift in how we think about glaucoma therapy.”

About QLS-111

QLS-111 is a novel topical ATP-sensitive potassium channel modulator that reduces IOP by selectively targeting EVP. The program was originally studied in the laboratory of Prof. Michael Fautsch, PhD, at Mayo Clinic and has been developed into Qlaris Bio’s non-preserved formulation, QLS-111. Clinical studies have demonstrated that treatment with QLS‑111 provides significant IOP lowering, maintains normal vascular integrity, and is well-tolerated without added hyperemia. (Trials: NCT06016972, NCT06249152).

About Qlaris Bio, Inc.

Founded in 2019, Qlaris Bio is a clinical-stage biotechnology company focused on developing innovative first-in-class therapies for glaucoma. The company’s lead program, QLS-111, is designed to address a significant unmet need in glaucoma treatment by targeting EVP. For more information, please visit www.qlaris.bio.