Pipeline

Ocuphire is developing a “pipeline within a product” for its lead ophthalmic drug candidate Nyxol. The most advanced front-of-the-eye clinical programs target night vision disturbances. Nyxol has been tested in more than 150 subjects across seven randomized, double-blind placebo-controlled Phase 1 and 2 trials. Nyxol is being advanced through the 505(b)(2) new drug application pathway in the United States and is covered by a broad global patent estate fully owned by Ocuphire, protecting the novel eye drop formulation and methods of use through at least 2034.

Upcoming trials planned for the first half of 2020 include a Phase 3 study for night vision disturbances (LYNX-1), a Phase 3 study for reversal of mydriasis (MIRA-2), and a Phase 2 study for presbyopia with a fixed-dose combination product (VEGA-1).

We are interested in adding novel ophthalmic early- to mid-stage clinical drug candidates to our portfolio. Please contact us to discuss business development opportunities.

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 efficacy following once daily evening 1% Nyxol drop dosing for 14 days.

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).