Nicox Announces Positive Pre-submission Regulatory Feedback in China Supporting NDA filing for NCX 470

Nicox's NCX 470 Receives Positive China CDE Pre-submission Feedback

Nicox SA announced that its exclusive licensee in China, Ocumension Therapeutics, has received positive pre-submission regulatory feedback from the Chinese Center for Drug Evaluation (CDE) for NCX 470. This feedback is considered sufficient for Ocumension to proceed with the New Drug Application (NDA) submission in China. The Chinese submission is expected to follow shortly after the U.S. FDA NDA submission, which Nicox's partner Kowa anticipates filing in summer 2026. NCX 470 (bimatoprost grenod) is a novel nitric oxide-donating bimatoprost eye drop aimed at lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

• Ocumension Therapeutics, Nicox's exclusive licensee for the Chinese market, has secured positive pre-submission regulatory feedback from the Chinese Center for Drug Evaluation (CDE) for NCX 470. This crucial feedback paves the way for Ocumension to proceed with the New Drug Application (NDA) submission in China, marking a significant step towards potential market approval in the region.
• The positive CDE feedback in China follows a recently announced successful pre-New Drug Application meeting with the U.S. FDA for NCX 470. Nicox anticipates that its exclusive U.S. partner, Kowa, will submit the NDA for NCX 470 in the U.S. in summer 2026, with the Chinese submission expected to follow shortly thereafter, demonstrating a coordinated global regulatory strategy.
• NCX 470 (bimatoprost grenod) is a novel nitric oxide-donating bimatoprost eye drop developed for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The drug is licensed globally to Kowa, with Ocumension Therapeutics holding exclusive rights for the Chinese, South Korean, and Southeast Asian markets. Nicox is set to receive regulatory and sales milestones, along with royalties on worldwide sales.

NCX 470's Profile Supporting Regulatory Submissions

NCX 470 (bimatoprost grenod) has demonstrated a consistent safety and tolerability profile across both clinical and preclinical settings. Conjunctival hyperemia represents the primary adverse event of note, a finding aligned with the known class effect of prostaglandin analogs, while no unexpected safety signals have emerged across species or dose levels studied.

• Clinical tolerability across all tested concentrations: In a 2022 clinical trial enrolling adult patients with bilateral open-angle glaucoma or ocular hypertension, NCX 470 was safe and well tolerated at all three evaluated concentrations — 0.021% (n=111), 0.042% (n=108), and 0.065% (n=107) — administered once daily in the evening for 4 weeks, compared against latanoprost 0.005% (n=107).

• Primary adverse event profile: Conjunctival hyperemia was the most frequently reported adverse event across all NCX 470 concentrations in the clinical trial, consistent with the prostaglandin analog drug class; adverse events were systematically evaluated at weeks 1, 2, and 4.

• Preclinical safety in ischemia/reperfusion models: A 2023 study employing an endothelin-1–induced ischemia/reperfusion injury model in rabbits demonstrated a favorable safety profile following repeated ocular dosing of NCX 470 0.1% twice daily, 6 days/week over multiple weeks, with findings attributable to nitric oxide– and bimatoprost-mediated mechanisms.

• Multispecies preclinical tolerability: A 2016 preclinical study evaluated NCX 470 in New Zealand white rabbits, cynomolgus monkeys, and normotensive dogs without reported safety or tolerability concerns across any species.

• Anticipated class-level safety alignment: A 2023 expert opinion indicated that nitric oxide–hybrid FP receptor agonists, including NCX 470, may demonstrate a safety profile broadly comparable to approved prostaglandin analogs currently used in clinical practice.

Addressing Unmet Needs in Open-Angle Glaucoma Treatment

Current treatment approaches for open-angle glaucoma (OAG) and ocular hypertension face a complex interplay of clinical, pharmacological, and systemic barriers that collectively limit optimal disease management. The largely asymptomatic nature of OAG contributes to high rates of underdiagnosis, with the disease remaining undetected in approximately half of affected individuals, and management is further constrained by the irreversibility of pre-existing optic nerve damage — making early, accurate diagnosis essential yet persistently challenging.

• Patient adherence and compliance: Non-compliance with therapeutic regimens is common and frequently underappreciated by clinicians, who often find it difficult to detect. Risk factors for non-compliance are multifactorial, and once-daily dosing is considered optimal for improving adherence. Education, improved physician-patient communication, compliance aids, and simplified regimens have been identified as key mitigation strategies.

• Medication-related adverse effects and ocular surface disease: Most IOP-lowering agents are associated with local and/or systemic adverse effects, short duration of action, and chronic tolerability issues. Long-term use of topical formulations — particularly those containing the preservative benzalkonium chloride — induces ocular surface changes including inflammatory cytokine release, tear film disruption, dry eye disease, and chronic inflammation, all of which may impair quality of life and further compromise adherence over a patient's lifetime.

• Surgical access and cost-effectiveness barriers: Early surgical intervention is gaining traction as a paradigm shift to preserve vision and quality of life, but implementation is limited by waiting lists and restricted surgical capacity. Economic analyses have shown that trabeculectomy is unlikely to be cost-effective at a threshold of £20,000 per quality-adjusted life-year (incremental cost: £45,456/QALY), presenting a significant barrier to adoption in resource-constrained healthcare systems.

• Underutilization of laser therapy as first-line treatment: Selective laser trabeculoplasty (SLT) is a safe and effective alternative, with 74.2% of patients requiring no topical drops to maintain target IOP at 36 months; however, it remains rarely used as a first-line option despite strong evidence supporting a change in clinical practice and a 97% probability of cost-effectiveness over eye drops at a £20,000/QALY willingness-to-pay threshold.

• Diagnostic complexity and late-stage treatment targeting: Decision-making has grown more complex with the introduction of innovative diagnostic tools and newer therapeutic agents. Current treatments predominantly target IOP reduction to slow optic nerve degeneration rather than addressing disease pathophysiology at its onset, leaving a critical gap in neuroprotective and disease-modifying strategies.

• Limitations of alternative and complementary therapies: At least 5% of the glaucoma population uses alternative and complementary therapies (ACT); however, evidence supporting the neuroprotective effects of agents such as Ginkgo biloba, bilberry, and alcohol remains weak. Lifestyle interventions (e.g., exercise, alcohol consumption) reduce IOP by only 1–2 mmHg, producing a clinically marginal effect, and ACT cannot substitute conventional IOP-lowering treatment in current practice.

• Holistic treatment philosophy versus current practice gaps: The overarching goal of glaucoma management is to preserve visual function and quality of life while minimizing the burden of cost, side effects, follow-up demands, and socioeconomic impact. Current approaches that focus narrowly on IOP, optic disc appearance, or visual field metrics fall short of treating the patient as a whole — a gap that continues to drive unmet need in long-term disease management.

NCX 470's Potential in the Evolving Glaucoma Landscape

Published studies spanning 2004–2025 collectively position investigational and next-generation IOP-lowering therapies within a well-characterized standard-of-care landscape dominated by prostaglandin analogs (PGAs), β-blockers, and surgical intervention. The evidence base reveals meaningful differentiation among agents across efficacy, tolerability, mechanism, and patient-specific applicability — with emerging therapies increasingly demonstrating complementary rather than replacement roles. Notably, monotherapy with any single agent fails to achieve satisfactory IOP control in 40–75% of glaucoma patients after more than two years of therapy, underscoring the need for combination strategies and novel mechanisms.

NCX 470: A Dual-Action Glaucoma Therapy Nears Global Launch

The recent positive pre-submission regulatory feedback from China's Center for Drug Evaluation (CDE) for NCX 470 marks a pivotal moment for Nicox SA and its licensee Ocumension Therapeutics. This development signals an imminent New Drug Application (NDA) submission in China, potentially preceding the anticipated US FDA filing in summer 2026. For a condition as prevalent and sight-threatening as open-angle glaucoma and ocular hypertension, the introduction of a novel, highly effective treatment could significantly impact patient care globally.

NCX 470 is a nitric oxide-donating bimatoprost, designed to leverage a dual mechanism of action by activating both prostaglandin F2α and nitric oxide/cGMP signaling pathways. This innovative approach has consistently demonstrated superior intraocular pressure (IOP) lowering compared to both bimatoprost and latanoprost in preclinical and clinical studies, including the Dolomites and MONT BLANC trials. The MONT BLANC study, for instance, showed NCX 470 0.1% lowered IOP more than latanoprost at multiple time points, suggesting a potential to redefine the standard of care.

Beyond its enhanced IOP-lowering capabilities, research indicates NCX 470 may offer additional benefits such as retinal cell protection and improved ocular hemodynamics, which could be crucial in mitigating visual field loss—a primary concern in glaucoma management. This positions NCX 470 not just as an incremental improvement but as a potentially transformative therapy.

However, as with any new ophthalmic agent, considerations remain. Conjunctival/ocular hyperemia was the most frequently reported adverse event in clinical trials, a common side effect of prostaglandin analogues that could influence patient compliance. While short-term efficacy and safety data are promising, the long-term profile of NCX 470 in chronic glaucoma management will be critical for widespread adoption. Furthermore, the competitive landscape already includes other nitric oxide-donating prostaglandin analogues, necessitating clear differentiation of NCX 470's unique advantages. Nevertheless, the strategic move to secure early regulatory traction in China underscores a global ambition for NCX 470, potentially establishing it as an important first-line therapy across diverse markets.