RUSH, NY – September 5, 2019 – Ocuphire Pharma, Inc., a clinical-stage pharmaceutical company and partner of iuvo BioScience’s ophthalmic-focused Oculos Division, announced that it has successfully enrolled 39 glaucoma patients in ORION-1 at 5 U.S. sites from late May to August 2019. Ocuphire has been collaborating closely with Oculos Development Services to achieve these clinical milestones.
The objectives of the randomized, placebo-controlled, double-masked study of once daily 1% Nyxol in subjects with open angle glaucoma or ocular hypertension are to evaluate Nyxol’s efficacy in lowering intraocular pressure (IOP) and to evaluate safety (NCT03960866).
“We were pleased by the rapid enrollment of subjects in both Phase 2b trials over the summer which speaks to the unmet needs. We thank our investigators, clinical coordinators, staff, and subjects for their support and ease of trial execution” said Chuck Slonim, MD, Chief Medical Officer and Medical Monitor of Oculos.
Ocuphire also initiated MIRA-1 in the summer and has already enrolled 26 subjects to date (representing 80% completion) at 4 U.S. sites. The objectives of this randomized, cross-over, double-masked, placebo-controlled study of a single 1% Nyxol dose in healthy subjects with medically-induced mydriasis are to evaluate Nyxol’s efficacy in time-to-reverse pupil dilation and to evaluate safety (NCT04024891).
Clinical results from both ORION-1 and MIRA-1 Phase 2b trials are expected in the fourth quarter of 2019.
The full press release from Ocuphire is available here.
Ocuphire is a clinical-stage biopharmaceutical company engaged in the development and commercialization of drugs to treat important ophthalmic disorders. The company’s lead drug candidate, preservative-free Nyxol Eye Drops, is being developed for multiple indications including night vision disturbances, glaucoma, reversal of mydriasis, and presbyopia. Please visit www.clinicaltrials.gov to learn more about the active Phase 2 clinical trials for glaucoma (NCT03960866) and reversal of mydriasis (NCT04024891). For more information, please visit www.ocuphire.com.
About iuvo BioScience
iuvo BioScience is a Partner Research Organization (PRO) serving the medical device and pharmaceutical industries. The Company provides contract laboratory services, as well as technical and preclinical consulting from its location in Western New York. The Company has extensive expertise in toxicology, analytical chemistry and microbiology. More information on the Company’s services and capabilities is available on the Company’s website at www.iuvobioscience.com.
Oculos, an iuvo BioScience company, is a truly integrated, full-service Partner Research Organization (PRO) with focused expertise in developing ophthalmological products, from pre-clinical testing, CMC / technical services and clinical ophthalmological research. Oculos and iuvo together provide complete support from the pre-clinical development stage through clinical trial management for ocular products. More information on Oculos’ services and capabilities are available at www.oculoscr.com.
For more information, contact iuvo at email@example.com.