Ocuphire Pharma, Inc. Initiates LYNX-1 Phase 3 Study Investigating Nyxol in Night Vision Disturbances
January 05, 2021 at 12:00 pm
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Ocuphire Pharma, Inc. announced the initiation of patient recruitment and screening in late December for its LYNX-1 Phase 3 registration study evaluating the safety and efficacy of Nyxol® in night vision disturbances (NVD) at multiple sites in the US. NVD, also known as dim light vision disturbances, is a condition in which peripheral imperfections (aberrations) of the cornea scatter light when the pupil dilates in dim light conditions. These imperfections can be naturally occurring, especially with age, or surgically-induced from refractive procedures such as LASIK. Patients with NVD experience glare, halos, starbursts and decreased contrast sensitivity. The effects of NVD can be reduced or eliminated by moderately reducing pupil diameter to avoid some of the aberrations and their scattering effect, without impeding the ability to see at night. Four major patient subpopulations of NVD have been identified based on their underlying cause of aberrations: night myopia (naturally occurring), non-central cataracts, post-LASIK procedures, and post-IOL implantation. These conditions span an age range of late teenagers to those 80 years and older.
Ocuphire Pharma, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders. The Companyâs lead retinal product candidate, APX3330, is a small-molecule inhibitor of Ref-1 (reduction oxidation effector factor-1 protein). Ref1 is a regulator of transcription factors such as HIF-1α and NF-B. The Inhibiting REF-1 reduces levels of vascular endothelial growth factor (VEGF) and inflammatory cytokines which are known to play key roles in ocular angiogenesis and inflammation. APX3330 is an oral tablet to be administered twice per day for the treatment of DR. The Companyâs pipeline candidates include APX2009 and APX2014. The Company is initially pursuing APX3330 for the DR indication as first-line therapy and may explore opportunities for clinical benefit as monotherapy or adjunctive therapy for other retinal indications such as DME, wAMD, and GA.