Qlaris Bio Doses First Patient in Phase 2 Nightingale Trial for Normal Tension Glaucoma

Qlaris Bio has announced the dosing of the first patient in the Nightingale Phase 2 clinical trial evaluating QLS-111, its lead investigational therapy, in patients with normal tension glaucoma (NTG). This marks a key advancement in the company’s ongoing efforts to address NTG, a form of glaucoma where intraocular pressure (IOP) remains within normal limits yet still leads to progressive vision loss.

The Nightingale trial is being conducted in South Korea, a region with one of the highest prevalence rates of NTG globally. The country offers access to a large and clinically relevant patient population for studying this often-overlooked subtype of glaucoma. This is Qlaris Bio’s third Phase 2 trial of QLS-111, following earlier Osprey and Apteryx studies, both of which yielded positive clinical outcomes in patients with ocular hypertension (OHT) and open-angle glaucoma (OAG).

QLS-111 Targets Episcleral Venous Pressure in Normal Tension Glaucoma

QLS-111 is a first-in-class, topical ATP-sensitive potassium channel modulator that lowers IOP by reducing episcleral venous pressure (EVP), a physiological parameter that defines the minimum IOP achievable with conventional treatments. Since patients with NTG typically exhibit IOP within a "normal" range, targeting EVP may offer a new therapeutic pathway for reducing disease progression.

“NTG is highly prevalent in Asia, and many of our patients struggle with ongoing vision loss despite IOPs that appear ‘normal’ by conventional standards,” said Ki Ho Park, MD, PhD, Professor of Ophthalmology at Seoul National University College of Medicine and lead investigator of the Nightingale study.
“We are excited to evaluate QLS-111. A therapy that targets EVP may offer a much-needed new strategy for pressure reduction and disease control in this population.”

About the Nightingale Phase 2 Study

The Nightingale trial is a masked, randomized Phase 2 clinical study designed to evaluate the safety, tolerability, and efficacy of QLS-111 in adults with NTG. The trial is taking place across multiple clinical sites in South Korea.

This study builds upon Qlaris Bio’s earlier U.S.-based Phase 2 trials, Osprey and Apteryx, which demonstrated favorable safety and efficacy data for QLS-111 in ocular hypertension and open-angle glaucoma, both as monotherapy and in combination with latanoprost.

“The initiation of the Nightingale study is an exciting milestone in our mission to address unmet needs in glaucoma,” said Thurein Htoo, Chief Executive Officer, Qlaris Bio.
“We believe that targeting EVP is a fundamentally new and important mechanism that can benefit many patients worldwide, especially as a complement to other therapies for patients requiring further IOP control without added side effects, such as hyperemia.”