bimatoprost grenod (NCX 470) / Nicox, Kowa, Ocumension Therap - LARVOL DELTA

Ocumension Therapeutics has announced that China’s National Medical Products Administration has accepted its new drug application for OT-301, an ophthalmic solution intended to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension (TipRanks) - "The filing is supported by results from the Mont Blanc and Denali phase III trials, marking a regulatory milestone in the company’s push to expand its glaucoma portfolio in China. The Mont Blanc trial, completed in the U.S. and China in 2022, demonstrated robust efficacy and safety, while the Denali multi-regional phase III study met its primary endpoint of non-inferiority to the current standard of care, latanoprost, in August 2025."

China filing • Glaucoma • Ophthalmology

Nicox SA…announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for NCX 470 (bimatoprost grenod; also known as K-911 in Kowa’s publications) for filing and set 30 April 2027 as the Prescription Drug User Fee Act (PDUFA) date for a response on review of the dossier. (The Manila Times) - "The NDA submission was based on positive results from the Mont Blanc and Denali Phase 3 clinical trials, which together were designed to meet regulatory requirements for efficacy and safety in support of approval in the United States and China....U.S. Launch: targeted in H2 2027, subject to FDA approval."

FDA filing • Launch US • PDUFA • Glaucoma

Ocumension has submitted the New Drug Application (NDA) to the Chinese National Medical Products Administration (NMPA) for NCX 470 to lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension (GlobeNewswire) - "The NDA includes the Phase 3 program of both the Mont Blanc trial, and the Denali trial, which specifically included Chinese clinical sites, allowing the program to complete the clinical requirements for approval in China, the same data as recently submitted to the U.S. FDA."

China filing • Glaucoma • Ophthalmology

Nicox’s NCX 470 New Drug Application Submitted in the United States by Kowa, with Associated €3 million Milestone Payment (GlobeNewswire) - "The NDA submission is supported by positive results from the Mont Blanc and Denali Phase 3 clinical trials...The NCX 470 NDA is expected to be the subject of a standard 12-month review period, which would lead to approval in mid-2027, and an expected commercial launch in the U.S. before the end of 2027."

FDA approval • FDA filing • Financing • Launch US • Glaucoma • Ophthalmology

Nicox Announces Positive Pre-Submission Regulatory Feedback in China Supporting NDA Filing for NCX 470 (GlobeNewswire) - "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 for NCX 470...Ocumension considers the feedback is sufficient to proceed with the submission of the dossier for marketing approval of NCX 470 to the Chinese National Institutes for Food and Drug Control...NCX 470 NDA submission in the United States: expected in summer 2026...NCX 470 NDA submission in China: expected shortly after submission in the U.S."

China filing • FDA filing • Non-US regulatory • Glaucoma

Prostaglandin analogues in cosmetic products formulated for eyelash lengthening. (PubMed, Ann Pharm Fr) - "Six prostaglandin analogues were found, including bimatoprost and norbimatoprost. The most common are ethyl tafluprostamide, also known as dechloro dihydroxy difluoro ethyl cloprostenolamine (DDDE), and isopropyl cloprostenate...Conclusion : Serums containing prostaglandin analogues are therefore available on the market and are promoted as eyelash growth treatments. They pose a number of problems as they are not regulated for use in cosmetic products."

Journal

Nicox SA…announced that it has received positive written feedback from its NCX 470 pre-NDA (New Drug Application) meeting with the U.S. Food and Drug Administration (FDA). (GlobeNewswire) - "The minutes confirm that the current data package and the proposed content and format of the proposed NDA application is generally acceptable for submission. The FDA requested complementary pharmacokinetic data, which will be generated in a small number of patients as part of an ongoing study in Japan, and will not impact any timelines....Key Future Milestones: NCX 470 NDA submission in the United States: expected in summer 2026; NCX 470 NDA submission in China: expected shortly after submission in the U.S."

China filing • FDA event • FDA filing • Glaucoma

Nicox Completes NCX 470 New Drug Application Key Data Generation for Submission as Planned in H1 2026 (The Manila Times) - "Pre-NDA meeting with the U.S. Food and Drug Administration (FDA) in preparation; U.S. NDA submission on-track as planned in H1 2026; Submission of NDA in China similarly on track for 2026."

China filing • FDA filing • Ophthalmology

Denali: MRCT Evaluating NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension (clinicaltrials.gov) - P3 | N=696 | Completed | Sponsor: Nicox Ophthalmics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Glaucoma • Ophthalmology

Nicox Announces Last Patient Completes the NCX 470 Denali Phase 3 Clinical Trial (GlobeNewswire) - "Nicox SA...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...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."

FDA filing • P3 data: top line • Trial status • Glaucoma • Hypertension

NCX 470 Phase 3 clinical efficacy and long-term safety trials in Japan (GlobeNewswire) - "Initiation expected in H2 2025"

New P3 trial • Glaucoma

Nicox Announces up to €3 million in Milestone Payments from Kowa in 2025 as NCX 470 Prepares to Enter Phase 3 Clinical Trials in Japan (The Manila Times) - "Nicox SA...announced that its exclusive Japanese partner for NCX 470, Kowa, has received Clinical Trial Notification (equivalent of a U.S. Investigational New Drug, IND) approval to initiate Phase 3 clinical trials on NCX 470 for the treatment of ocular hypertension in Japan, triggering a €1 million milestone payment to Nicox. The clinical trials are expected to be initiated in H2 2025, which would trigger a second milestone payment of €2 million."

Financing • New P3 trial • Ophthalmology

Nicox Provides Full Year 2024 Financial Results (GlobeNewswire) - "Key Future Milestones: Whistler Phase 3b clinical trial investigating NCX 470’s dual mechanism of action (nitric oxide and prostaglandin analog) in intraocular pressure lowering: Results are expected in May 2025. Denali Phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: Topline results are expected in the third quarter of 2025."

P3 data • P3 data: top line • Glaucoma • Ophthalmology

Whistler: Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution (clinicaltrials.gov) - P2/3 | N=18 | Completed | Sponsor: Nicox Ophthalmics, Inc. | Recruiting ➔ Completed

Trial completion • Glaucoma • Ophthalmology

Nicox Announces Last Patient Completes Final Visit in NCX 470 Phase 3b Whistler Glaucoma Trial (GlobeNewswire) - "Nicox SA...announced that the last patient completed their final visit in the Whistler Phase 3b clinical trial investigating the dual mechanism of action (nitric oxide and prostaglandin analog) of NCX 470 in intraocular pressure (IOP) lowering. The Whistler Phase 3b trial enrolled 18 healthy volunteers with ocular hypertension in a double-masked, placebo-controlled study investigating the action of NCX 470 on aqueous humor parameters including trabecular meshwork outflow and episcleral venous pressure....Results expected in May 2025. Last patient in the U.S. in the ongoing NCX 470 Denali Phase 3 trial has also completed their last visit and results remain on track for Q3 2025."

P3 data • Trial status • Glaucoma • Ophthalmology

HPLC method for detecting prostaglandin F2α analogs in cosmetics: Optimization for chromatographic separation and sample preparation. (PubMed, J Pharm Biomed Anal) - "Some prostaglandin F2α (PGF2α) analogs, including bimatoprost and tafluprost, are pharmaceutical substances known to cause specific abnormal reactions that promote eyelash growth. The verified analytical method was applied to eyelash serums currently available in the market, and norbimatoprost was detected in one product. The HPLC method proposed in this study may help prevent the distribution of cosmetics containing illegal PGF2α analogs."

Journal

Nicox Presents New Analysis from the NCX 470 Mont Blanc Trial and Provides Development Update (GlobeNewswire) - "Nicox SA...today provided details of a poster presentation highlighting additional pre-planned analysis from the NCX 470 Mont Blanc Phase 3 clinical trial at the 2025 American Glaucoma Society (AGS) Annual Meeting, one of the key scientific events in vision research, which was held on February 26 to March 2, 2025 in Washington, United States. The Company also provided an update on NCX 470 Development....'We also look forward to announcing the results of the Whistler trial, investigating the mechanism of action of NCX 470, shortly, and the second pivotal Phase 3 trial, Denali, in Q3 of this year.'"

P3 data • Glaucoma • Ophthalmology

Nicox Announces Scientific Presentation and Conference Attendance in H1 2025 (GlobeNewswire) - "Nicox SA...announced a presentation at the upcoming American Glaucoma Society (AGS) Annual Meeting 2025 and participation in a number of key ophthalmology and financial conferences in the first half of 2025....Presentation of additional analysis of the NCX 470 Mont Blanc Phase 3 Clinical trial"

P3 data • Glaucoma

Denali: MRCT Evaluating NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension (clinicaltrials.gov) - P3 | N=696 | Active, not recruiting | Sponsor: Nicox Ophthalmics, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2025 ➔ Mar 2025

Enrollment closed • Trial primary completion date • Cardiovascular • Glaucoma • Ophthalmology

A phase 3 adaptive dose selection trial of NCX 470, a nitric oxide-donating bimatoprost for open-angle glaucoma or ocular hypertension: The MONT BLANC study. (PubMed, Contemp Clin Trials) - "Both concentrations of the NO-donating bimatoprost NCX lower IOP more than latanoprost following 2 weeks of daily therapy. This adaptive dose selection design allowed identification of the optimal dose of NCX 470 with reduced trial costs, recruitment time, and the number of patients exposed to study medication."

Journal • P3 data • Cardiovascular • Glaucoma • Ophthalmology

Nicox Announces Recruitment of Last Patient in U.S. in Denali Phase 3 Trial of NCX 470 (GlobeNewswire) - "Nicox SA...today announced the recruitment and randomization of the last patient in the U.S. in its Denali Phase 3 trial of NCX 470. The Denali trial is evaluating NCX 470 safety and efficacy in patients with open-angle glaucoma or ocular hypertension and topline results continue to be expected in H2 2025, based on this completion of recruitment of patients in the U.S. and continuing good progress of the trial in China, where recruitment of patients is still ongoing. More than 95% of the total target number of patients have been randomized in this trial so far...The U.S. NDA for NCX 470 is expected to be submitted in H1 2026."

FDA filing • P3 data: top line • Trial status • Glaucoma • Ophthalmology

Nicox Provides Second Quarter 2024 Update (GlobeNewswire) - "Nicox SA...today provided the revenue and cash position for Nicox SA and its subsidiaries (the 'Nicox Group') for the second quarter of 2024 and provided an update on key activities...Approval and launch of ZERVIATE in China by Nicox’s partner, Ocumension Therapeutics: expected in 2024. Whistler Phase 3b clinical trial, initiated in December 2023, investigating NCX 470’s (bimatoprost grenod) dual mechanism of action (nitric oxide and prostaglandin analog) in IOP2 lowering: results are currently expected in the first quarter of 2025. Denali Phase 3 clinical trial evaluating NCX 470 in patients with open-angle glaucoma or ocular hypertension: the randomization in the Denali trial is approaching the 95% level and expected to generate topline results in H2 2025, based on current recruitment rates. Completion of recruitment of patients in the U.S. is expected in Q4 2024."

China approval • Launch non-US • P3 data • Trial status • Glaucoma • Ophthalmology

Tolerability and intraocular pressure (IOP)-lowering efficacy following 5-day repeated dosing with NCX 470 0.1% ophthalmic solution, Lumigan® and Rhopressa®: a comparative head-to-head study in rabbits and dogs. (ARVO 2024) - "Describe the big picture and the implications of your findings, not the study itself and the associated details.: NCX 470 is an NO-donating bimatoprost in Phase 3 clinical development for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension; the compound met the primary end-point of 'non-inferiority' against latanoprost (0.005%) in the 1st phase 3 trial (Mont Blanc) with the 2nd trial (Denali) having similar design still ongoing. NCX 470 elicited greater IOP reduction compared to Lumigan®; Rhopressa® showed virtually no effect under our testing conditions. In addition, NCX 470 at clinically effective dose was well tolerated while Rhopressa® and, albeit less, Lumigan®, resulted in severe to mild hyperemia following repeated 5-days dosing. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand."

Clinical • Head-to-Head • Preclinical • Glaucoma • Ophthalmology

A Randomized, Controlled Comparison of NCX 470, a Nitric Oxide-Donating Bimatoprost, and Latanoprost in Subjects with Open-Angle Glaucoma or Ocular Hypertension: The MONT BLANC Study. (PubMed, Am J Ophthalmol) - "The NO-donating prostaglandin analogue NCX 470 0.1% was well-tolerated and lowered IOP more than latanoprost in subjects with open-angle glaucoma or ocular hypertension at all 6 time points. With a dual mechanism of action that enhances both uveoscleral and trabecular outflow, NCX 470 could become an important first-line therapy for IOP reduction in glaucoma."

Journal • Cardiovascular • Glaucoma • Ophthalmology

Whistler: Aqueous Humor Dynamics of NCX 470 Ophthalmic Solution (clinicaltrials.gov) - P2/3 | N=20 | Recruiting | Sponsor: Nicox Ophthalmics, Inc. | Not yet recruiting ➔ Recruiting | Phase classification: P3b ➔ P2/3 | Trial completion date: Dec 2024 ➔ Mar 2025 | Trial primary completion date: Dec 2024 ➔ Mar 2025

Enrollment open • Phase classification • Trial completion date • Trial primary completion date • Glaucoma • Ophthalmology