Clinical-stage pharma company Ocuphire Pharma, Inc has recently announced the completion of the first phase of their Two-Phase 2b Nyxol Eye Drops clinical studies, with the successful enrollment of 39 patients of glaucoma in the ORION-1 at 5 sites across the US from the end of May to August 2019. Ocuphire is focused on developing and commercializing treatments for patients suffering from ophthalmic disorders.
This study evaluates the safety and efficacy of Nyxol Eye Drops (once daily 1%) in lowering the IOP (intraocular pressure) in ocular hypertension or open angle glaucoma patients through a randomized, placebo-controlled double-masked trial.
The Michigan-based biopharmaceutical firm launched a similar trial earlier, MIRA-1 which has 26 participants enrolled to date (which represent 80% completion) across 4 US sites. This randomized, cross-over, placebo controlled, double masked study was initiated with the objective of evaluating the time-efficacy of 1% single dose of Nyxol in healthy subjects with medically induced mydriasis, in reversing pupil dilation and to test safety.
The results from both clinical trials (ORION-1 & MIRA-1) are expected in the last quarter of 2019.
Ocuphire is working closely with Tampa-based clinical research expert Oculus Development Services for these achievements.
Chuck Slonim, Oculus MD, Chief Medical Officer and Medical Monitor has reportedly been quoted as stating that they are optimistic about the results thanks to the rapid subject enrollment for both Phase 2b trials which respond to unmet needs. He added a note of thanks to everyone involved in the trials, including investigators, clinical coordinators, subjects and staff for their contribution towards execution of the studies.
The ORION-1 and MIRA-1 trials for Nyxol have generated over $5 million through investments by institutional investors, directors and officers. Chair, President & CEO of Ocuphire, Mina Sooch has shared their anticipation of the trial results and commitment towards advancing Nyxol, their lead drug candidate in age-related, progressive ocular disorders as well as adding new ophthalmic treatment candidates to their portfolio and emerge as a leading biopharma company.
Ms. Sooch also announced Ocuphire’s late stage clinical program and commercial opportunities to investors, as well as plans for a Phase 3 Nyxol study in treating night vision disturbances, expected to commence in 2020.