Qlaris Bio Announces Positive Topline Data From Two Phase 2 Trials of QLS-111 for Glaucoma

Qlaris Bio announced positive topline results from two US phase 2 clinical trials investigating QLS-111 in patients with primary open angle glaucoma (POAG) and ocular hypertension (OHT). The trials (Osprey and Apteryx) successfully met all primary and secondary endpoints. Qlaris Bio will present a corporate update at the Glaucoma 360 New Horizons Forum 2025 on February 7 in San Francisco.

The Osprey study (NCT06016972), is a masked, randomized trial assessing the safety, tolerability, and IOP-lowering activity of QLS‑111 across a range of doses compared to vehicle in 62 adult patients with POAG or OHT. The study demonstrated that the 0.015% concentration of QLS-111 dosed QPM (once daily in the evening) drove the greatest decrease in IOP, highlighted by mean reductions of 3.7 mmHg from mean diurnal baseline IOP of 23.0 mmHg.

The Apteryx study (NCT06249152) is a masked, randomized trial assessing the safety, tolerability, and additive IOP-lowering efficacy of QLS‑111 dosed in addition to latanoprost compared to latanoprost alone in 32 patients aged 12 years or older with POAG or OHT who were stable on latanoprost monotherapy. Patients’ mean diurnal baseline IOP with latanoprost monotherapy was 19.8 mmHg. QLS-111 0.015% dosed with latanoprost drove additive mean IOP reductions as compared to latanoprost monotherapy, achieving a 3.2 mmHg greater reduction for QLS-111 QPM dosing and 3.6 mmHg greater reduction for QLS-111 BID (twice daily) dosing.

According to Qlaris, all QLS-111 concentrations and dose regimens across both studies demonstrated excellent safety and tolerability. No serious adverse events were reported, nor did investigators observe any clinically meaningful hyperemia or other ocular or systemic adverse events. In addition, no incremental hyperemia was observed when QLS-111 0.015% was added to latanoprost.

“We are pleased with QLS-111’s performance in our phase II Osprey and Apteryx trials,” Thurein Htoo, Chief Executive Officer, Qlaris Bio, said in a company news release. “These results with our novel preservative-free formulation give us confidence that the selective targeting of episcleral venous pressure (EVP) with QLS-111 has the potential to be a first-in-class therapeutic.”

“The data show QLS-111’s synergistic ability to provide significant IOP lowering in patients already on latanoprost,” said Barbara Wirostko, MD, FARVO, Chief Medical Officer, Qlaris Bio. “This substantial additive effect demonstrates the potential to significantly benefit patients who do not achieve IOP lowering goals with current therapies. Additionally, we believe the promising tolerability profile of QLS-111 will further enhance the value to our patients by driving improved treatment compliance and adherence. This is supported by the absence of clinically relevant hyperemia, with no corneal changes and no clinically relevant ocular or systemic findings thus far in our studies.”