QLS-111

DEDHAM, Mass.--( BUSINESS WIRE )-- Qlaris Bio, Inc. , a clinical-stage biotechnology company targeting unmet needs in debilitating ophthalmic diseases, today announced positive topline results from two U.S. Phase II clinical trials investigating QLS-111 in patients with primary open angle glaucoma (POAG) and ocular hypertension (OHT). The Phase II 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 th in San Francisco, CA. The Osprey study ( NCT06016972 ), is a masked, randomized trial assessing the safety, tolerability, and intraocular pressure (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. Importantly, 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,” said Thurein Htoo, Chief Executive Officer, Qlaris Bio. “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.” “The QLS-111 Phase II data are quite promising and indicative of an innovative therapy,” said Professor Ike Ahmed, MD, FRCSC, Director of the Alan S. Crandall Center for Glaucoma Innovation at the Moran Eye Center, University of Utah. “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 the potential of these procedures.” About QLS‑111 QLS‑111 is a novel topical formulation using Qlaris Bio’s ATP-sensitive potassium channel modulator platform originally developed by Michael Fautsch, Ph.D., professor of ophthalmology, biochemistry, and molecular biology at the Mayo Clinic in Rochester, Minnesota. QLS-111 lowers IOP by relaxing vessels of the vascular and vascular-like tissues distal to the trabecular meshwork, thereby reducing distal outflow resistance and lowering EVP. Though multiple mechanisms of action exist to lower IOP in patients with glaucoma, these agents target only three of the four components of IOP as described by the Goldmann equation for IOP: the aqueous humor inflow rate, the uveoscleral outflow rate, and the conventional outflow facility. There are currently no approved drugs that primarily target the reduction of EVP. This leaves a significant gap in the potential to maximally lower IOP, since EVP can be the largest determinant of overall IOP. About Qlaris Bio, Inc. Qlaris Bio, Inc. was founded in August 2019 with a singular focus: to develop novel, innovative therapies with first-in-class mechanisms of action to address serious and debilitating ophthalmic diseases. The company’s lead program, QLS‑111, uses ATP-sensitive potassium channel modulators that improve outflow through distal vascular tissues of the eye to reduce IOP. Qlaris Bio’s investors include Canaan and New Leaf Venture Partners, who co-led the company’s $24 million Series B funding round in April 2024. Other investors include Correlation Ventures, Mayo Clinic, and funds managed by abrdn Inc. For more information, please visit www.qlaris.bio .

A first-in-class product, QLS‑111 is designed to lower intraocular pressure (IOP) beyond currently achievable levels in patients with glaucoma by targeting episcleral venous pressure (EVP) DEDHAM, Mass.--(BUSINESS WIRE)-- Qlaris Bio, Inc. (“Qlaris”), a clinical-stage biotechnology company targeting unmet needs in debilitating ophthalmic diseases, today announced the initiation and dosing of two separate U.S. Phase II masked, randomized clinical trials investigating QLS‑111 in patients with ocular hypertension and glaucoma. “The start of these Phase II trials represents a key milestone in our goal of bringing QLS‑111 to glaucoma patients for whom consistent IOP lowering and control has been an unachievable goal,” said Thurein Htoo, Chief Executive Officer. “IOP remains the only modifiable risk factor for the treatment of glaucoma, and additional treatments are needed for patients. QLS‑111 has the potential to change the treatment paradigm by effectively reducing IOP by lowering EVP, an unaddressed component of IOP.” Qlaris is initiating the following studies: The Osprey study (NCT06016972) will assess the safety, tolerability, and optimal dose of QLS‑111 compared with vehicle alone in adult patients who have primary open-angle glaucoma (POAG) and/or ocular hypertension (OHT). The efficacy of QLS-111 in lowering IOP will be assessed as a secondary endpoint of the trial. The Apteryx study (NCT06249152) will evaluate the safety and tolerability, and measure the additive IOP-lowering efficacy, of QLS‑111 in combination with latanoprost versus latanoprost alone. Patients aged 12 years or older and who have open-angle glaucoma (OAG) and/or OHT currently on latanoprost will be enrolled in the trial. “We are very pleased to initiate these studies in support of QLS-111 clinical development,” said Barbara Wirostko, MD, FARVO, Chief Medical Officer. “Despite the number of therapies currently available to clinicians, there remains a critical unmet need for new drugs that target unique parameters within IOP regulation with a strong safety profile. With a novel mechanism of action that targets EVP, as well as early data demonstrating it may be used in combination with existing treatments, QLS‑111 has the potential to make a significant impact.” QLS‑111 is an ATP-sensitive potassium channel modulator that is designed to reduce IOP by reducing EVP and distal outflow resistance, making it potentially suitable for treating POAG, OHT, and normal tension glaucoma (NTG). Current medications fall into two categories, those that reduce aqueous humor production and those that target proximal outflow. However, none of the current medications directly address distal outflow and EVP. This is important as EVP contributes up to 50% of total IOP, often leaving patients unable to reach IOP reduction goals to slow their disease progression, despite currently available therapies. QLS‑111's complementary mechanism may offer a significant and synergistic advantage in managing IOP. “I’m very excited about the promise of QLS‑111, which in healthy, normotensive volunteers lowered pressure significantly from baseline,” said Shan Lin, MD, Co-Research Director at the Glaucoma Center of San Francisco — a QLS‑111 investigational site — and a member of the Qlaris Scientific Advisory Board. “This suggests that QLS‑111 will benefit patients who do not adequately respond to currently available drugs due to the IOP floor set by EVP. Importantly, this compound has demonstrated that it can work alone or in combination with several current glaucoma drug classes, indicating that its use with current medications will aid in the ability to achieve levels of IOP reduction that slow disease progression. With its strong safety pro no clinically meaningful hyperemia, QLS‑111 holds enormous promise for our patients.” About QLS‑111 QLS‑111 is a novel topical formulation using Qlaris Bio’s ATP-sensitive potassium channel modulator platform originally developed by Dr. Michael Fautsch, PhD, professor of ophthalmology, biochemistry, and molecular biology at Mayo Clinic, in Rochester, Minnesota. QLS-111 lowers IOP by relaxing vessels of the vascular and vascular-like tissues distal to the trabecular meshwork, thereby reducing distal outflow resistance and lowering EVP. Though multiple mechanisms of action exist to lower IOP in patients with glaucoma, these agents target only three of the four components of IOP as described by the Goldman equation for IOP: the aqueous humor inflow rate, the uveoscleral outflow rate, and the conventional outflow facility. There are currently no approved drugs that selectively target the reduction of EVP. This leaves a significant gap in the potential to maximally lower IOP, since EVP can be the largest determinant of overall IOP. Studies have demonstrated that treatment with QLS‑111 provides persistent lowering of IOP, maintains normal vascular integrity of the venous system, is well-tolerated, and thus far has shown it does not cause hyperemia. About Qlaris Bio, Inc. Qlaris Bio, Inc. was founded in August 2019 with a singular focus: to develop novel, innovative therapies with first-in-class mechanisms of action to address serious and debilitating ophthalmic diseases. The company’s lead program, QLS‑111, uses ATP-sensitive potassium channel modulators that improve outflow through distal vascular tissues of the eye to reduce IOP. Qlaris Bio’s investors include Canaan and New Leaf Venture Partners, both of which were co-lead investors in the company’s $25 million Series A funding round in August 2019. Other investors include Correlation Ventures and Mayo Clinic, where the science behind QLS‑111 originated. For more information, please visit .