Ocuphire Pharma (NASDAQ: OCUP) is a publicly traded, clinical-stage, ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of refractive and retinal eye disorders.
Ocuphire has a previously disclosed pharma partnership to develop and commercialize Nyxol(R) eye drops as a preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size by uniquely blocking the alpha-1 receptors found only on the iris dilator muscle without affecting the ciliary muscle. Nyxol has been studied in a total of 12 clinical trials (3 Phase 1, 5 Phase 2, 4 Phase 3) across three indications, including single-use for reversal of pharmacologically-induced mydriasis (“RM”), and once-daily for treatment of presbyopia and dim light (night) vision disturbances (“DLD”), pending regulatory approvals. Nyxol’s NDA under the 505(b)(2) pathway for the first indication RM has been accepted with a PDUFA date assigned of September 28, 2023, and is currently in Phase 3 for presbyopia and DLD.
Ocuphire’s other late-stage product candidate APX3330 is a first-in-class, small molecule, oral drug that blocks downstream pathways regulated by transcription factor Ref-1 – including those involving angiogenesis (“VEGF”) and inflammation (“NFkB”). These pathways are implicated across several ocular diseases, including diabetic retinopathy (“DR”), diabetic macular edema (“DME”), and age-related macular degeneration (“AMD”). Ocuphire recently announced topline data from the ZETA-1 Phase 2 trial in which APX3330 achieved statistical significance on a key pre-specified secondary endpoint of preventing clinically meaningful progression of (“DR”) after 24 weeks of daily treatment. APX3330 has also shown a favorable safety and tolerability profile in diabetic subjects (ZETA-1 trial) and in 11 previous clinical trials conducted in healthy, liver disease, and cancer subjects.
To learn more about Ocuphire Pharma, visit https://ocuphire.com
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Mina Sooch, President & CEO
Ocuphire Pharma, Inc.
ir@ocuphire.com
www.ocuphire.com
Bret Shapiro
CORE IR
brets@coreir.com
