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Ocuphire Pharma, Inc. (Nasdaq: OCUP) is a clinical-stage biopharmaceutical company dedicated to developing and commercializing small-molecule therapies for retinal and refractive eye disorders. Focused on addressing unmet medical needs in ocular diseases, Ocuphire's innovative pipeline includes two main product candidates: Nyxol and APX3330.
Nyxol (phentolamine ophthalmic solution 0.75%) is in advanced clinical development for various indications. It was approved by the FDA under the brand name RYZUMVI™ in September 2023 for the reversal of pharmacologically-induced mydriasis. Nyxol is also in Phase 3 clinical trials for the treatment of presbyopia and decreased visual acuity under low light (mesopic) conditions following keratorefractive surgery.
APX3330 is an oral small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein) aimed at treating diabetic retinopathy (DR) and diabetic macular edema. APX3330 has shown promise in slowing DR progression and is poised to enter Phase 2/3 pivotal trials, following a successful Phase 2 study and productive discussions with the FDA regarding Special Protocol Assessment.
Ocuphire’s experienced management team boasts over 100 years of combined drug development expertise across ophthalmology, orphan diseases, cardiology, nephrology, oncology, and respiratory diseases. The company is also exploring additional delivery routes and second-generation Ref-1 inhibitors, such as APX2009 and APX2014, for treating other retinal diseases like age-related macular degeneration and geographic atrophy.
Ocuphire's strategic partnership with Viatris, Inc. strengthens its commercial potential. Viatris collaborates with Ocuphire in developing and marketing Nyxol and other product candidates. Recent financial highlights reveal Ocuphire's robust fiscal health, with cash reserves expected to fund operations into mid-2025, bolstered by significant milestones and collaboration revenue.
For more information, visit www.ocuphire.com.
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