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Ocuphire Provides Corporate Update: Announcing Enrollment Completion of Phase 3 Nyxol Trial, Enrollment Initiation of Nyxol Pediatric Trial, and an Investor R&D Day in January
Completed Enrollment of Nyxol® LYNX-1 Phase 3 NVD Trial Initiated Enrollment of Nyxol MIRA-4 Pediatric Study in RM per Agreed Initial Pediatric Study Plan
About this update from Opus Genetics, Inc.
[{"type":"text","content":"Completed Enrollment of Nyxol® LYNX-1 Phase 3 NVD Trial Initiated Enrollment of Nyxol MIRA-4 Pediatric Study in RM per Agreed Initial Pediatric Study Plan with FDA Nyxol MIRA-3 Phase 3 Results, MIRA-4 Pediatric Results, and LYNX-1 Phase 3 Results Expected in Early 2022 Strengthened Balance Sheet Extends Runway into Q2 2023 Company to Host Virtual Investor R&D Day on January 31st FARMINGTON HILLS, Mich., Jan. 05, 2022 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, today provided a corporate update available on the Company’s website. This update includes recent progress on Nyxol® trials, the Company’s cash position, and the announcement of an Investor R&D day in late January. “We are looking forward to a catalyst-rich 2022 and the opportunity to build on the tremendous progress over the past year advancing our differentiated therapeutic candidates in front and back of the eye indications,” stated Mina Sooch, MBA, President and CEO. “Our development program for Nyxol in the Reversal of Mydriasis (RM) indication is now in its final stages. We have recently agreed on an Initial Pediatric Study Plan (iPSP) with the FDA and began enrolling pediatric subjects ages 3 to 11 in the MIRA-4 study in late December. We also continue to enroll adults and 12 to 17 year-old subjects in MIRA-3, which is the second pivotal trial for the RM indication expected to read-out around the end of the first quarter. A positive outcome in MIRA-3 will position us to submit an NDA for Nyxol for RM in late 2022. We are also happy to report that this week marks the completion of over 140 subjects enrolled in LYNX-1, a Phase 3 pivotal trial for Nyxol in Night Vision Disturbances (NVD). We look forward to providing clinical updates on Nyxol in presbyopia and RM as well as APX3330 in diabetic retinopathy at our upcoming Virtual Investor R&D Day.” Initiated Enrollment in MIRA-4 Pediatric Trial in Reversal of Mydriasis: Ocuphire recently enrolled the first subjects in MIRA-4, which is a randomized, double-masked, placebo-controlled study of Nyxol eye drops to reverse pharmacologically-induced mydriasis in healthy pediatric subjects. Approximately 20 pediatric subjects ages 3 to 11 will be enrol...