In 2019, Ocuphire successfully completed two Phase 2b trials for Nyxol: ORION-1 and MIRA-1. Based on these and 5 other Phase 1 and Phase 2 prior trials, upcoming US clinical trials for Nyxol Eye Drops include a Phase 3 in NVD (LYNX-1), Phase 3 in RM (MIRA-2), and a Phase 2 POC in Presbyopia (Nyxol with Low Dose Miotic, VEGA-1). Based on the results of these clinical trials and on regulatory feedback, Ocuphire expects, alone or with a partner, to file its first NDA (Nyxol) with the FDA through a 505(b)(2) drug approval path, and in parallel make additional ex-US filings. APX3330 is a novel oral tablet with one recently completed Phase 1 oncology trial: APX-CLN-0011. Based on this and 10 other Phase 1 and Phase 2 prior trials, upcoming clinical plan for APX3330 includes a Phase 2 clinical trial in DR/DME (ZETA-1).
2019 Completed Trials
ORION-1 was a multi-center, randomized, double-masked, placebo-controlled, multiple-dose Phase 2b study in 39 subjects (average age 60) with elevated intraocular pressure (IOP) ≥ 22 and ≤30 mmHg, evaluating safety, dosing schedule, pupil modulation, vision performance and IOP first-line efficacy following once daily evening 1% Nyxol drop dosing for 14 days. Study results will be presented at ARVO 2020.
MIRA-1 was a multi-center, randomized, double-masked, placebo-controlled, crossover, single-dose Phase 2b trial with 32 healthy subjects (average age 28) to study 1% Nyxol’s safety and efficacy in reducing pharmacologically induced mydriasis (dilation of pupil for eye exams). Study results will be presented at ARVO 2020.