Kowa Company, Ltd.'s submission of a New Drug Application (NDA) to the US FDA for NCX 470 (bimatoprost grenod), developed by France-based Nicox SA (Paris: COX), represents the second nitric oxide-donating prostaglandin analog to reach the FDA review stage, building on experience with Vyzulta while evaluating a different prostaglandin backbone. Kowa is seeking approval for the molecule to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
The NDA was submitted by Kowa, Nicox's exclusive US licensee, and is subject to a standard 12-month review period, the company said, meaning commercial launch in the US is anticipated before the end of 2027. The submission triggers a EUR 3 million milestone payment to Nicox from Kowa, with a further milestone due upon approval. Kowa bears all regulatory and commercialization costs in the US and in Japan, where a separate Phase III program was initiated in summer 2025. Ocumension Therapeutics holds equivalent rights for China, South Korea, and Southeast Asia, and positive pre-submission regulatory feedback from China's Center for Drug Evaluation was announced in June 2026, with a Chinese filing expected to follow shortly after the US submission.
The FDA NDA package is supported by data from two Phase III clinical trials, Mont Blanc and Denali, which were designed jointly to satisfy regulatory requirements for both US and Chinese approval. Both trials demonstrated that NCX 470 achieved clinically meaningful reductions in IOP with a favorable safety profile, the company said. The Denali trial, the more extensively characterized of the two, was a randomized study comparing NCX 470 0.1% once daily to latanoprost 0.005% once daily in patients with open-angle glaucoma or ocular hypertension. Results presented at the 2026 American Glaucoma Society Annual Meeting indicated that NCX 470 met its pre-specified non-inferiority criterion against latanoprost at every assessed time point and demonstrated statistically superior IOP reductions at three of six evaluated time points, with reductions of up to 10 mmHg from baseline.
NCX 470 is a bimatoprost analog engineered to release nitric oxide at the site of action in the trabecular meshwork. Bimatoprost, a prostamide analog, primarily enhances uveoscleral outflow; nitric oxide donation is hypothesized to add a complementary effect by relaxing trabecular meshwork smooth muscle and increasing conventional outflow facility. This dual mechanism distinguishes NCX 470 from latanoprost and bimatoprost alone, both of which act predominantly through uveoscleral pathways, and from netarsudil, a Rho kinase inhibitor that targets trabecular outflow but lacks the prostaglandin component. The combination of both outflow pathways in a single molecule is the central mechanistic rationale for the IOP reductions observed in the Phase III program.