October 16, 2019, Andover, MA and Tempe, AZ – Ora and SDC congratulate Nicox S.A. (Euronext Paris: FR0013018124, COX) on their recent announcement of positive topline results from their Phase 2 clinical trial of NCX 470 for glaucoma. On October 2, 2019, Nicox, an international ophthalmology company, announced positive topline results from its U.S. multicenter, Dolomites dose-response Phase 2 clinical trial evaluating investigational NCX 470, a novel second-generation nitric oxide (NO)-donating bimatoprost analog, compared to latanoprost ophthalmic solution, 0.005% in 433 patients with open-angle glaucoma or ocular hypertension. Nicox reported that NCX 470 met the primary endpoint of non-inferiority and demonstrated superiority to latanoprost in multiple pre-specified analyses; additionally, NCX 470 was well-tolerated at all doses with no drug-related serious adverse events.
“We congratulate Nicox on the exciting topline results from their Phase II glaucoma trial,” said Dale W. Usner, Ph.D., CSO & Sr. VP, Strategic Scientific Consulting at SDC. “We are proud to be part of the NCX 470 clinical program and very pleased to see the positive results that came from this well-run clinical trial.” SDC performed biostatistics, clinical data management, electronic data capture (EDC), and interactive response technology (IRT) services for the Phase II clinical trial.
The study was conducted by Ora, Inc., the world’s leading full-service ophthalmic CRO and product development firm. Keith Lane, Therapeutic Area Head-Posterior Segment at Ora commented, “We congratulate the Nicox team for achieving such a significant IOP reduction of up to 9.8 mm Hg. This treatment was very well-tolerated and has tremendous potential as a first-line therapy for glaucoma patients. On behalf of the team at Ora, we are proud to be a part of the NCX 470 program.”
For more information, please see Nicox’s full and original press release dated October 2, 2019: Top Line Results from Glaucoma Dolomites Phase 2 Trial Show Nicox’s NCX 470 Meets Primary Endpoint and Demonstrates Statistical Superiority vs Latanoprost.