Nicox SA, an international ophthalmology company, announces the submission of an NDA to the US FDA for NCX 470 (also known as K-911) by exclusive US licensee Kowa, representing an important step toward potential commercialisation in the US.
NCX 470 (bimatoprost grenod), Nicox’s lead clinical product candidate, is a novel nitric oxide-donating bimatoprost eye drop for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
“Submission of the NDA for NCX 470 in the United States represents a major milestone for Nicox and reflects the dedication of our teams, our partners and the support of our clinical
trial sites and patients."
"Based on the strength of the Phase III data from the Mont Blanc and Denali trials, NCX 470 has the potential to offer an important new treatment option for patients with glaucoma or ocular hypertension. We look forward to working closely with Kowa and the FDA during the review process,” said Doug Hubatsch, Chief Scientific Officer of Nicox.
“This collaboration shows the complementarity of the teams, with Nicox bringing in-depth expertise of the molecule and the development program, coupled with a strong external
network, combining with Kowa’s broad regulatory and commercial capabilities."
"We look forward to continuing to work together as we prepare for the commercial launch of NCX 470 in the US, which is planned to take place shortly after approval of the NDA in mid-2027,” said Junichi Kawagoe, Director and Senior Managing Executive Officer of Kowa.
The NDA submission is supported by positive results from the Mont Blanc and Denali Phase III clinical trials, which were designed to meet regulatory requirements for efficacy and safety to support approval in the United States and China.
These trials demonstrated that NCX 470 achieved clinically meaningful reductions in IOP with a favourable safety profile.
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 US before the end of 2027.
Launch of NCX 470 will bring a new, sustainable and recurrent revenue stream to the Company
