Qlaris Bio, a Massachusetts-based clinical-stage biotechnology company, announced development of a novel preservative-free, fixed-dose combination therapy that combines its lead investigational asset QLS-111 with latanoprost for glaucoma treatment. The combination, designated QLS-111-FDC, represents a potentially significant advancement in addressing an unmet medical need in glaucoma care.
Targeting an Unaddressed Component of IOP Control
The fixed-dose combination is being developed specifically for patients with primary open-angle glaucoma (POAG), normal-tension glaucoma (NTG), and ocular hypertension (OHT) for whom optimal intraocular pressure (IOP) control may remain unachievable due to the need to lower episcleral venous pressure (EVP). According to Qlaris, EVP remains the only component of IOP that is not addressed by currently FDA-approved treatments in the U.S. market.
QLS-111 utilizes a first-in-class ATP-sensitive potassium (KATP) channel modulator mechanism designed to lower IOP by selectively reducing episcleral venous pressure through vasodilatory action. The investigational eye drop works by relaxing vessels of the vascular and vascular-like tissues distal to the trabecular meshwork, leading to reduced distal outflow resistance and lowering of EVP.
Complementary Dual Mechanism Approach
The combination therapy pairs QLS-111's novel mechanism with latanoprost, a prostaglandin analogue that represents the gold standard in glaucoma care and was the first FDA-approved prostaglandin for ocular use in 1996. Latanoprost lowers IOP by increasing uveoscleral outflow, creating what Qlaris describes as a "complementary dual mechanism approach aimed to further enhance IOP control."
Phase 2 Clinical Data Supports Combination Strategy
The development of QLS-111-FDC is supported by positive findings from two phase 2 clinical trials, including the Apteryx study, which evaluated QLS-111 in patients with POAG and ocular hypertension. In these randomized trials, patients received either latanoprost alone or latanoprost with one of three different QLS-111 doses administered twice daily.
The clinical data demonstrated that the 0.015% QLS-111 concentration, when administered in addition to latanoprost monotherapy, achieved over 3 mmHg of additional IOP reduction compared to latanoprost monotherapy alone. Importantly, this additive efficacy was achieved without additional hyperemia or other clinically meaningful adverse events.
Addressing Treatment Adherence Challenges
"Patients who remain uncontrolled on monotherapy often face challenges with multi-drug therapy, which can negatively impact adherence and outcomes," said Barbara Wirostko, MD, FARVO, Chief Medical Officer of Qlaris Bio. "A fixed-dose combination simplifies treatment regimens and, with the strong safety and additive efficacy profile of QLS-111, may offer an important option for patients requiring further IOP lowering."
Dr. Wirostko emphasized the clinical significance of QLS-111's safety profile, noting that "the recently completed phase 2 studies show that QLS-111 does not cause additional hyperemia, which will be important for patient compliance."
Clinical Development Strategy
Qlaris Bio's therapeutic pipeline is specifically targeted toward treating ophthalmic diseases with unmet needs, with particular emphasis on glaucoma and ocular hypertension. The company has identified three key areas for its approach: new mechanisms of action to address glaucoma's unique aspects not covered by current therapies, sustained-duration therapies that reduce eye drop burden and control IOP fluctuation, and novel neuroprotective therapies that operate independently from IOP-lowering medications.
While Qlaris announced the development of QLS-111-FDC, the company has not yet disclosed specific clinical trial plans for the combination therapy. Further details regarding the clinical development timeline are expected to be announced in the near future.
