Latanoprost

June 30, 2025 – release at 7:30 am CET Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that the last patient has completed the Denali Phase 3 trial, evaluating the efficacy and safety of NCX 470, its lead compound, in patients with open-angle glaucoma or ocular hypertension. With this milestone reached, all patients have now completed their treatment and follow-up visits. A total of 696 patients were enrolled in the trial and topline results are expected mid-August to mid-September 2025. “Reaching the milestone of the last patient last visit in the Denali Phase 3 trial is a great achievement by our clinical sites, our partner Ocumension and the Nicox development team who have continued to drive this trial. I would like to thank everyone who has been involved in the conduct of the Denali trial including our patients, investigators and their staff.” said Doug Hubatsch, Chief Scientific Officer of Nicox “We look forward to announcing the topline results in the near future, which we expect will further consolidate the profile of NCX 470 and confirm its potential in the glaucoma market. We remain fully focused on completing the clinical development program and preparing for regulatory submissions.” NCX 470, Nicox’s lead clinical product candidate, is a novel NO-donating bimatoprost eye drop, currently in Phase 3 clinical development for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The Denali trial is evaluating the IOP lowering efficacy of once-daily dosed NCX 470 ophthalmic solution 0.1% compared to latanoprost ophthalmic solution 0.005% in patients with open-angle glaucoma or ocular hypertension. It is a multi-country (U.S. and China) clinical trial financed equally by Nicox and Ocumension, Nicox’s exclusive licensee for China, Korea and Southeast Asia. The Denali trial, together with the already completed Mont Blanc trial, was designed to fulfil the clinical regulatory requirements to support New Drug Application (NDA) submissions of NCX 470 in the U.S. and China. All remaining NDA-enabling pharmacokinetic and non-clinical studies necessary to support the U.S. NDA filing are on track. Subject to securing a U.S. partner, or obtaining the necessary funding, the Company estimates that a NDA for this country NCX 470 could potentially be submitted in H1 2026. Denali Phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: Topline results are expected mid-August to mid-September 2025 NCX 470 Phase 3 clinical efficacy and long-term safety trials in Japan: Initiation expected in H2 2025 NCX 470 NDA filing in the United States: expected in H1 2026, subject to securing a U.S. partner, or obtaining the necessary funding Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health. Nicox’s lead program in clinical development is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, licensed to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets and to Kowa for Japan. Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos. Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories. Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets. The content above comes from the network. if any infringement, please contact us to modify.

DEDHAM, Mass.--(BUSINESS WIRE)--Qlaris Bio, Inc., a clinical-stage biotechnology company, today announced that it is developing a novel preservative-free, fixed-dose combination (FDC) therapy that combines the company’s lead program, QLS-111, and latanoprost, the most commonly prescribed prostaglandin analogue for the treatment of glaucoma. The QLS-111 and latanoprost fixed-dose combination (QLS-111-FDC) is being developed as a treatment for patients with primary open angle glaucoma (POAG), ocular hypertension (OHT), and normal tension glaucoma (NTG) for whom optimal intraocular pressure (IOP) control may remain unachievable due to the need to lower episcleral venous pressure (EVP). EVP, which is the target of QLS-111, remains the only component of IOP that is not addressed by currently approved treatments. QLS-111 utilizes a first-in-class ATP-sensitive potassium channel modulator designed to lower IOP by selectively reducing EVP, which may represent the largest component of IOP in patients. Latanoprost, a gold standard in glaucoma care, lowers IOP by increasing uveoscleral outflow. Together, the agents offer a complementary dual mechanism approach aimed to further enhance IOP control. Reduction of IOP remains the only modifiable risk factor shown to slow the progression to blindness in patients with glaucoma. Data from Qlaris Bio’s Phase 2 study in POAG and OHT patients, the Apteryx study, demonstrated that QLS-111, 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, supporting the potential of QLS-111-FDC to provide improved IOP control without compromising safety or tolerability. “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. Importantly, the recently completed Phase 2 studies show that QLS-111 does not cause additional hyperemia, which will be important for patient compliance.” “Combining QLS-111 with latanoprost in a preservative-free fixed-dose combination is a very promising and exciting advancement,” said Alex Huang, MD, PhD, Associate Professor at the Shiley Eye Institute at UC San Diego Health. “This approach targets two distinct and complementary mechanisms and could offer improved IOP control in a single topical eyedrop—something that aligns well with real-world needs of patients surrounding compliance and long-term IOP control. Targeting the reduction of EVP and distal outflow to lower IOP represents a fundamental shift in how we think about glaucoma therapy.” About QLS-111 QLS-111 is a novel topical ATP-sensitive potassium channel modulator that reduces IOP by selectively targeting EVP. The program was originally studied in the laboratory of Prof. Michael Fautsch, PhD, at Mayo Clinic and has been developed into Qlaris Bio’s non-preserved formulation, QLS-111. Clinical studies have demonstrated that treatment with QLS‑111 provides significant IOP lowering, maintains normal vascular integrity, and is well-tolerated without added hyperemia. (Trials: NCT06016972, NCT06249152). About Qlaris Bio, Inc. Founded in 2019, Qlaris Bio is a clinical-stage biotechnology company focused on developing innovative first-in-class therapies for glaucoma. The company’s lead program, QLS-111, is designed to address a significant unmet need in glaucoma treatment by targeting EVP. For more information, please visit www.qlaris.bio.