Qlaris Bio, Inc. has released positive topline findings from two phase 2 clinical trials evaluating its lead asset: QLS-111, under clinical investigation for patients with primary open-angle glaucoma (POAG) and ocular hypertension (OHT).
First, a rundown on Qlaris.
The Dedham, Massachusetts-based clinical-stage biotechnology company is developing therapeutics to target ophthalmic diseases with unmet needs, including:
- Normal-tension glaucoma
- Primary open-angle glaucoma
- OHT
Why focus on glaucoma: Qlaris is targeting three key areas of unmet needs the disease is associated with:
- New mechanisms of action (MOA) enabling treatment for glaucoma’s “unique aspects” not addressed by current therapies on the market
- Therapies with a sustained duration of action that reduce eye drop burden and control IOP fluctuation on a daily basis
- Novel neuroprotective therapies operating independently from IOP-lowering meds to protect the optic nerve and preserve vision
Now let’s talk about this asset.
Targeting the first key unmet need, QLS-111 is an investigational therapeutic representing a potential new MOA for glaucoma.
What it is: A novel topical formulation intended to lower IOP by reducing episcleral venous pressure (EVP) via a vasodilatory MOA.
- Quick definitions:
- Vasodilatory refers to the process of widening blood vessels to enable blood to flow more easily throughout the body.
- EVP is the pressure within the veins surround the eye—and, most importantly, a key determinant of IOP that can lead to glaucoma development
Got it. So how does QLS-111 work?
The therapeutic lowers IOP by “relaxing vessels of the vascular and vascular-like tissues distal to the trabecular meshwork (TM),” resulting in a reduction of distal outflow resistance and a lowered EVP.
- What it uses to do this: Adenosine triphosphate-sensitive potassium (KATP) channel modulators—which typically treat conditions like type 2 diabetes by opening or closing KATP channels—that improve the outflow through distal vascular tissues of the eye to reduce IOP.
The potential: With no therapy currently approved to primarily target EVP reduction, QLS-111 has the potential to be a major game-changer for IOP-related disorders—including glaucoma.
Interesting … next: tell me about these trials.
Evaluating the safety, tolerability, and additive IOP-lowering efficacy of QLS-111, these randomized, vehicle-controlled, double-masked phase 2 studies include:
Osprey (NCT06016972)
- Trial type: Active-controlled and multisite
- Participants: 62 patients (aged 18+) diagnosed with POAG or OHT
- Note: This number is an update to the Clinical Trials page, which reads 63
- The setup: Randomized to receive placebo or three varying doses of QLS-111:
- 0.015%
- 0.030%
- 0.075%
- Broken down: Administered every morning (QAM) for 7 days, followed by every evening (QPM) for 7 days, then twice daily (BID) for 7 days
- Duration: 21 days
- Outcome measures: Among seven primary endpoints, these included ocular treatment-emergent adverse events (TEAEs) and clinically significant changes in visual acuity (VA).
- See here for all primary and secondary endpoints measured at Day 28.
Aptreyx (NCT06249152)
- Trial type: prospective parallel pilot study
- Participants: 36 patients (aged 12+) diagnosed with POAG and/or OHT
- The setup: Randomized to receive latanoprost or three varying doses of QLS-111 (see below) in addition to latanoprost:
- 0.015%
- 0.030%
- 0.075%
- Broken down: Administered every evening (QPM) for 14 days, then BID for 7 days
- Duration: 28 days
- The outcome measures: Same as those in the Osprey trial, except measured at Day 28
- See here for all primary and secondary endpoints
Now these positive results.
First: Both studies met all primary and secondary endpoints.
We’ll start with the Osprey study’s topline data.
Overall: The study demonstrated that the 0.015% QLS-111 concentration (dosed QPM) resulted in the greatest IOP decrease.
- The numbers: Mean reductions were 3.7 mmHg from mean diurnal baseline IOP of 23.0 mmHg
And how did this compare to the Apteryx study’s results?
For participants receiving the latanoprost monotherapy, the mean diurnal baseline IOP was 19.8 mmHg.
And similar to the Osprey results: The 0.015% QLS-111 dosage achieved additive (a combined effect of both QLS-111 and latanoprost) mean IOP reductions compared to latanoprost alone.
- The numbers: A 3.2 mmHg greater reduction for QLS-111 QPM dosing and a 3.6 mmHg greater reduction for QLS-111 BID dosing
Any other similarities between the two data sets?
In both studies, all QLS-111 concentrations and dose regimens “demonstrated excellent safety and tolerability,” Qlaris reported.
As for adverse events (AEs): Investigators noted no serious AEs or clinically meaningful hyperemia, nor other ocular or systemic AEs.
- In the Apteryx trial: “No incremental hyperemia was observed when QLS-111 0.015% was added to latanoprost,” according to the company.
Sounds promising … so what did Qlaris have to say?
In speaking on the Apteryx study results:
Chief Medical Officer Barbara Wirostko, MD, FARVO, stated that this topline data demonstrates QLS-111’s “synergistic ability to provide significant IOP lowering in patients already on latanoprost.”
She continued: “This substantial additive effect demonstrates the potential to significantly benefit patients who do not achieve IOP lowering goals with current therapies.”
Go on …
The therapeutic’s potential also lends to surpassing the additive efficacy of other glaucoma medications when used with latanoprost—translating to patients being able to stay on the drug long enough to achieve better IOP control, according to Ike Ahmed, MD, FRCSC.
- A world-renowned pioneer in glaucoma therapeutics who coined the term “micro-invasive glaucoma surgery (MIGS),” Dr. Ahmed is the director of the Moran Eye Center’s Alan S. Crandall Center for Glaucoma Innovation at the University of Utah.
“Furthermore, the possibility of combining QLS-111 with [TM] MIGS procedures to address downstream resistance may unlock the potential of these procedures,” he added.
How exciting! Where can I learn more about what this company is up to?
If you’re attending this weekend’s Glaucoma 360 in San Francisco, California, you’re in luck!
Qlaris will present a corporate update during the meeting’s New Horizons Forum on Feb. 7 from 2 to 3:05 pm PST.
This article was updated on Feb. 6, 2025.