Nicox SA announced positive topline results from its Dolomites dose-response, US multicenter Phase 2 clinal trial of investigational NCX 470. The drug is aimed at lowering intraocular pressure (IOP) to treat ocular hypertension and open-angle glaucoma.
The trial included 433 patients and compared NCX 470 0.065% and latanoprost ophthalmic solution 0.005%.
Results showed that NCX 470 0.065% was statistically significantly better than latanoprost in a pre-specified secondary efficacy analysis. Researchers also claim it demonstrated the highest IOP reduction from baseline in a glaucoma trial (7.6 to 9.8 mmHg for NCX 470 vs. 6.3 to 8.8 mmHg for latanoprost).
Nicox SA is planning an end-of-phase 2 meeting with the FDA in the first quarter of next year. Phase 3 trials plan include comparing NCX 470 with a prostaglandin analog.
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