Qlaris Bio has reported positive topline outcomes from two randomised Phase II US trials, Osprey and Apteryx, of QLS 111 in individuals with primary open-angle glaucoma (POAG) and ocular hypertension (OHT).
All primary and secondary endpoints were met in the two masked trials.
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The Osprey trial evaluated the tolerability, intraocular pressure (IOP)-lowering activity, and safety of the therapy across various doses against a vehicle in 62 POAG or OHT adult subjects.
The trial found that the 0.015% concentration of the therapy, administered one time a day in the evening, led to significant IOP reductions, with a mean decrease of 3.7mmHg from a mean diurnal baseline IOP of 23mmHg.
Similarly, the Apteryx study assessed the additive IOP-lowering efficacy, as well as the safety and tolerability of the therapy when dosed alongside latanoprost versus latanoprost alone.
The assessment was made on 32 subjects who were 12 years of age and above and who were “stable” on latanoprost monotherapy.
The addition of QLS-111 0.015% resulted in further IOP minimisations, with a 3.2mmHg greater decrease for once-daily evening dosing, as well as a 3.6mmHg greater decrease for twice-daily dosing, compared to latanoprost alone.
All concentrations and dosing regimens of the therapy have shown “excellent” tolerability and safety profiles, without any serious adverse events or clinically meaningful hyperaemia observed. Moreover, there was no incremental hyperaemia noted when QLS-111 0.015% was combined with latanoprost.
Qlaris Bio chief medical officer Barbara Wirostko said: “The data show QLS-111’s synergistic ability to provide significant IOP lowering in patients already on latanoprost.”
“This substantial additive effect demonstrates the potential to significantly benefit patients who do not achieve IOP lowering goals with current therapies.”
Leveraging an adenosine triphosphate (ATP)-sensitive potassium channel modulator platform, QLS‑111 is a topical formulation developed by Michael Fautsch, ophthalmology, biochemistry, and molecular biology professor at Mayo Clinic, Rochester, Minnesota.
In April 2021, the company announced the first subject enrolment in the Phase I/II clinical programme of its lead investigational product candidate, QLS-101, for treating individuals with glaucoma.
