Qlaris Bio Developing Fixed-Dose Combination Therapy for the Treatment of Glaucoma

Qlaris Bio announced it is developing a novel preservative-free, fixed-dose combination therapy that combines the company’s lead program, QLS-111, and latanoprost. The 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 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, according to Qlaris.

QLS-111 utilizes a first-in-class ATP-sensitive potassium channel modulator designed to lower IOP by selectively reducing episcleral venous pressure. Latanoprost, a gold standard in glaucoma care, lowers IOP by increasing uveoscleral outflow. Together, Qlaris says the agents offer a complementary dual mechanism approach aimed to further enhance IOP control. 

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. 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,” Barbara Wirostko, MD, FARVO, Chief Medical Officer of Qlaris Bio, said in a company news release. “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.”