Welcome to our dedicated page for Ocuphire Pharma news (Ticker: OCUP), a resource for investors and traders seeking the latest updates and insights on Ocuphire Pharma stock.
The OCUP news archive on Stock Titan captures the period when Ocuphire Pharma, Inc. was a standalone clinical-stage ophthalmic biopharmaceutical company and the subsequent transition to Opus Genetics, Inc. Company press releases describe a focus on therapies for retinal and refractive eye disorders, including non-proliferative diabetic retinopathy, presbyopia, dim light vision disturbances after keratorefractive surgery, and pharmacologically induced mydriasis.
Historical OCUP news includes clinical trial milestones for APX3330, an oral small-molecule inhibitor of Ref-1 being developed for diabetic retinopathy, and Phentolamine Ophthalmic Solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size. Releases detail Phase 2 and Phase 3 study designs, subset analyses from the ZETA-1 trial in diabetic retinopathy, and pivotal MIRA-2 and MIRA-3 results that supported FDA approval of Phentolamine Ophthalmic Solution 0.75% as RYZUMVI™ for pharmacologically induced mydriasis.
News items also track the initiation and progress of the VEGA-3 Phase 3 trial in presbyopia and the LYNX-2 Phase 3 registration trial in dim light disturbances, as well as scientific presentations at meetings such as ARVO, ASRS, Clinical Trials at the Summit, and the Retinal Imaging Biomarkers & Endpoints Summit. Corporate updates have covered financial results, collaboration and license agreements, and the eventual all-stock acquisition of Opus Genetics, Inc., after which the combined company was renamed Opus Genetics and began trading under the Nasdaq ticker "IRD."
Investors and researchers can use this OCUP news history to follow how the company’s strategy evolved from small-molecule ophthalmic drugs toward a broader portfolio that now includes adeno-associated virus-based gene therapies for inherited retinal diseases under the Opus Genetics name.
Ocuphire Pharma announced positive top-line results from its MIRA-2 Phase 3 trial for Nyxol, designed to reverse pharmacologically-induced pupil dilation. The trial met its primary endpoint, showing 49% of Nyxol-treated subjects returned to ≤ 0.2 mm of baseline pupil diameter at 90 minutes, significantly outperforming the 7% in the placebo group (p < 0.0001). Nyxol demonstrated a favorable safety profile with no serious adverse events. Plans for a second Phase 3 trial (MIRA-3) in 2021 and a New Drug Application submission to the FDA in early 2023 are underway.
Ocuphire Pharma (Nasdaq: OCUP) reported its 2020 financial results, highlighting a significant transformation year. The company raised over $21 million through a reverse merger with Rexahn Pharmaceuticals. In 2020, Ocuphire initiated and completed enrollment in multiple clinical trials, notably the Phase 3 MIRA-2 trial for Nyxol. Financially, the company faced a net loss of $24.6 million, up from $6.2 million in 2019, with cash reserves at approximately $16.4 million as of year-end. Key milestones for 2021 include top-line data releases from ongoing trials.
Ocuphire Pharma (Nasdaq: OCUP) announced positive findings from the MIRA-1 Phase 2b trial on Nyxol®, demonstrating its efficacy in reversing pharmacologically induced mydriasis. Published in Optometry and Visual Science, results showed 29% of subjects treated with Nyxol returned to baseline pupil diameter at 2 hours versus 13% with placebo. The upcoming MIRA-2 Phase 3 trial, designed based on MIRA-1 outcomes, aims to further validate Nyxol's potential, with topline results expected in March 2021. These findings highlight Nyxol's promise as a unique treatment option for post-exam pupil dilation.
Ocuphire Pharma (Nasdaq: OCUP) announces participation in two upcoming conferences. CEO Mina Sooch will present at the HC Wainwright Global Life Sciences Conference on March 9, 2021, at 7:00 am ET, and at the Oppenheimer 31st Annual Healthcare Conference on March 18, 2021, at 9:20 am ET. Both presentations will be available via webcast. Ocuphire focuses on developing therapies for eye disorders, including its lead product Nyxol, which targets pupil constriction and has undergone extensive clinical trials. The company explores partnerships for further development.
Ocuphire Pharma (Nasdaq: OCUP) has initiated patient enrollment in the Phase 2 VEGA-1 trial, assessing the combination of Nyxol and low-dose pilocarpine for treating presbyopia. The trial will include approximately 152 patients with a primary endpoint focusing on improvements in near visual acuity. Nyxol has previously shown a 20% reduction in pupil diameter and significant enhancement in near vision. With presbyopia affecting over 120 million Americans, the company's dual-drug approach targets a substantial market, and results are anticipated by the end of Q2 2021.
Ocuphire Pharma, a clinical-stage ophthalmic biopharmaceutical company (Nasdaq: OCUP), announced that CEO Mina Sooch will present a corporate overview at the 2021 BIO CEO & Investor Conference from February 16-18, 2021. The company will also participate in a panel discussion on February 19, 2021, focusing on key events in ophthalmology. Attendees can access a pre-recorded presentation via the conference portal until March 14. Ocuphire's pipeline includes Nyxol, a lead product entering Phase 3 trials for night vision disturbances, and APX3330, an oral tablet for retinal diseases.
Ocuphire Pharma (NASDAQ: OCUP) announced significant findings from its ORION-1 Phase 2 trial, demonstrating Nyxol's eye drops achieve a 20% reduction in pupil diameter for over 30 hours. Over 60% of patients showed improvement in near visual acuity, surpassing placebo results. The study was published in Clinical Ophthalmology. Ocuphire aims to initiate a Phase 2 trial for presbyopia and has begun the LYNX-1 Phase 3 trial for night vision disturbances. The company anticipates a transformational year in 2021 with multiple late-stage trials planned.
Ocuphire Pharma, Inc. (Nasdaq: OCUP) announced the successful early enrollment completion of its Phase 3 MIRA-2 clinical trial for Nyxol®, designed to reverse pharmacologically-induced pupil dilation. The trial's goal is to demonstrate the efficacy and safety of Nyxol compared to placebo in 185 subjects. Results from the previous Phase 2b trial indicate Nyxol's ability to quickly return pupil size to normal. Approximately 100 million eye exams requiring pupil dilation occur annually in the U.S., underscoring Nyxol's potential market value. Top-line data is expected by the end of Q1 2021.
Ocuphire Pharma (NASDAQ: OCUP) recently announced the initiation of patient recruitment for its LYNX-1 Phase 3 study, assessing the efficacy of Nyxol in treating night vision disturbances (NVD). This marks a significant step towards addressing a condition affecting approximately 38 million individuals in the U.S., with 16 million experiencing moderate-to-severe symptoms. The trial will enroll 160 patients across 15 sites, comparing Nyxol to placebo over 14 days. Nyxol’s development is notable as there are currently no FDA-approved treatments for NVD, presenting a unique market opportunity.
Ocuphire Pharma announced that CEO Mina Sooch will present at the LifeSci Partners 10th Annual Healthcare Corporate Access Event on January 7, 2021, at 11am ET. The company anticipates launching a Phase 2 trial for Nyxol® and low-dose pilocarpine eye drops to treat presbyopia in Q1 2021. Additionally, Ocuphire will participate in a panel on New Advances for Presbyopia on January 8, 2021, at 12pm ET. Investors can pre-register for both events. Ocuphire's pipeline includes Nyxol and APX3330, targeting various eye disorders.
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