Positive topline results from Qlaris Bio Phase 2 clinical trials find QLS-111 demonstrates IOP-lowering activity in patients with POAG, OHT
All QLS-11 concentrations and dose regimens in both Osprey and Apteryx trials “demonstrated excellent safety and tolerability,” according to the company.
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Clinical stage biotechnology company Qlaris Bio announced positive topline results from 2 of its US Phase 2 clinical trials investigating QLS-111 in patients with primary open angle glaucoma (POAG) and ocular hypertension (OHT).1 Osprey and Apteryx, the masked, randomized Phase 2 trials, successfully met all primary and secondary endpoints, according to a news release.
“We are pleased with QLS-111’s performance in our Phase 2 Osprey and Apteryx trials,” said Thurein Htoo, CEO of Qlaris Bio, in the release. “These results with our novel preservative free formulation give us confidence that the selective targeting of episcleral venous pressure with QLS-111 has the potential to be a first-in-class therapeutic.”
The Osprey study (NCT06016972) assessed the safety, tolerability, and intraocular pressure (IOP)-lowering activity of QLS-111 in a range of doses compared to vehicle in 62 adult patients with POAG or OHT. The study found that the 0.015% concentration dosed once daily in the evening drove the greatest decrease in IOP, as seen in the mean reductions of 3.7 mmHg from mean diurnal baseline IOP of 23.0 mmHg.1
As for the Apteryx study, safety, tolerability, and additive IOP-lowering efficacy of QLS-11 was assessed when dosed in addition to latanoprost compared to latanoprost alone. The study involved 32 patients 12 years old or older with POAG or OHT who were stable on latanoprost monotherapy. The patients’ mean diurnal baseline IOP with latanoprost monotherapy was 19.8 mmHg. QLS-111 0.015% dosed with latanoprost demonstrated additive mean IOP reductions when compared to latanoprost monotherapy, and achieved a 3.2 mmHg greater reduction for QLS-111 QPM dosing and 3.6 mmHg greater reduction for QLS-111 twice daily dosing.1
“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 at Qlaris Bio, in the release. “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.”
Additionally, all QLS-11 concentrations and dose regimens in both studies “demonstrated excellent safety and tolerability,” according to Qlaris Bio. No serious adverse events were reported, with investigators also not finding any other ocular or systemic adverse events. Additionally, no incremental hyperemia was observed when QLS-111 0.015% was added to latanoprost.1
“The QLS-111 Phase 2 data are quite promising and indicative of an innovative therapy,” said Ike Ahmed, MD, FRCSC, director of the Alan S. Crandall Center for Glaucoma Innovation at the Moran Eye Center, University of Utah, in the release. “Along with its attractive safety profile, the potential of QLS-111 to surpass the additive efficacy of other glaucoma medications when used with latanoprost, means patients can remain on a drug that can achieve better IOP control. The robust results of the Osprey and Apteryx trials give me confidence that our patients may soon have an important new treatment option that targets this clear unmet need. Furthermore, the possibility of combining QLS-111 with trabecular meshwork MIGS procedures to address downstream resistance may unlock potential of these procedures.”
Qlaris Bio will be presenting a corporate update at the Glaucoma 360 New Horizons Forum 2025 on February 7 in San Francisco, California.1
Reference:
Qlaris Bio announces positive topline data from 2 Phase 2 trials of QLS-111 in patients with primary open angle glaucoma and ocular hypertension. News release. Qlaris Bio. February 5, 2025. Accessed February 5, 2025. https://qlaris.bio/qlaris-bio-announces-positive-topline-data-from-two-phase-ii-trials-of-qls-111-in-patients-with-primary-open-angle-glaucoma-and-ocular-hypertension/
