Qlaris Bio announced positive topline results from a pair of phase 2 clinical trials evaluating its investigational drug QLS-111 for patients with primary open-angle glaucoma (POAG) and ocular hypertension (OHT). QLS-111 is an adenosine triphosphate (ATP)–sensitive potassium channel opener (KATP channels) that lowers IOP by relaxing vessels of the vascular and vascular-like tissues distal to the trabecular meshwork, lowering episcleral venous pressure (EVP), which contributes to IOP. The drug met all primary and secondary endpoints, demonstrating significant intraocular pressure (IOP) reductions and a favorable safety profile, the company said in a press release.
The Osprey trial assessed QLS-111 across multiple doses in 62 adults with POAG or OHT. The 0.015% dose, administered once daily in the evening, achieved the greatest reduction in IOP, lowering it by 3.7 mmHg from a baseline of 23.0 mmHg.
The Apteryx trial evaluated QLS-111’s additive effect when combined with latanoprost in 32 patients aged 12 and older. Patients with a baseline IOP of 19.8 mmHg on latanoprost monotherapy experienced additional reductions of 3.2 mmHg with once-daily QLS-111 and 3.6 mmHg with twice-daily dosing.
Both studies reported no serious adverse events, with QLS-111 demonstrating good tolerability and no clinically significant hyperemia. The company reports that it will present further findings at the Glaucoma 360 New Horizons Forum on February 7 in San Francisco. RP