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

Qlaris Bio announced that the first patient has been dosed in its phase 2 Nightingale clinical trial of QLS-111, the company’s lead investigational therapy, in patients with normal tension glaucoma (NTG).

The Nightingale study represents the third phase 2 clinical trial of QLS-111 and aims to build upon the positive clinical data from the earlier Osprey and Apteryx trials. Notably, the Nightingale trial will be conducted in South Korea, which has one of the highest NTG prevalence rates worldwide, offering access to a large patient population.

QLS-111 is a first-in-class, topical ATP-sensitive potassium channel modulator. It lowers IOP by reducing episcleral venous pressure (EVP). EVP sets the 'floor' for IOP reduction with current therapies, making QLS-111’s novel mechanism particularly relevant for NTG patients, whose IOP often appears 'normal' yet continues to allow disease progression, according to Qlaris Bio.

“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 Trial

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

This study follows Qlaris Bio’s U.S.-based phase 2 trials—Osprey and Apteryx—both of which demonstrated encouraging safety and efficacy results in patients with ocular hypertension (OHT) and open angle glaucoma (OAG), including use 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 of 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.”