Qlaris Bio Achieves Dual Phase 2 Success in Glaucoma and Ocular Hypertension Trials

Qlaris Bio, a rising player in the ophthalmology space, has announced positive results from two phase 2 clinical trials for its novel eye drug, QLS-111. The studies, dubbed Osprey and Apteryx, demonstrated significant intraocular pressure (IOP) reduction in patients with primary open-angle glaucoma (POAG) and ocular hypertension (OHT).

QLS-111: A New Approach to IOP Reduction

QLS-111, developed using Qlaris' ATP-sensitive potassium channel modulator platform, represents a potential breakthrough in glaucoma treatment. The drug targets the reduction of episcleral venous pressure (EVP), a mechanism currently unexploited by approved medications. This unique approach could fill a critical gap in IOP management, as EVP can be a major determinant of overall IOP.

Osprey Study Results

In the Osprey study, which enrolled 62 adults with POAG or OHT, a 0.015% concentration of QLS-111 administered nightly resulted in a mean IOP reduction of 3.7 mmHg from baseline. This significant pressure decrease demonstrates the drug's potential as a monotherapy for these conditions.

Apteryx Study: Combination Therapy Shows Promise

The Apteryx study evaluated QLS-111 in combination with Pfizer's established glaucoma medication, Xalatan. The trial included 32 patients aged 12 and older with POAG or OHT who were stable on Xalatan therapy. Results showed:

• Patients receiving QLS-111 0.015% once daily in addition to Xalatan experienced a 3.2 mmHg greater reduction in IOP compared to Xalatan alone.
• A twice-daily regimen of QLS-111 0.015% with Xalatan yielded an even more substantial IOP reduction of 3.6 mmHg.

These findings highlight QLS-111's potential as an effective add-on therapy for patients not achieving optimal IOP control with current treatments.

Safety Profile and Future Prospects

Importantly, no serious adverse events were reported in either study. The absence of clinically meaningful hyperemia, a common side effect of glaucoma medications, is particularly noteworthy. Dr. Barbara Wirostko, Qlaris' Chief Medical Officer, emphasized the drug's promising tolerability profile, suggesting it could enhance patient compliance and adherence to treatment.

The success of these phase 2 trials follows Qlaris' $24 million series B funding round in April 2024, which prioritized the development of QLS-111. As the company moves forward, the pharmaceutical industry will be watching closely to see if this novel approach to IOP reduction can transform the landscape of glaucoma and ocular hypertension treatment.