We are a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of several eye disorders. Ocuphire’s pipeline currently includes two small-molecule product candidates targeting front and back of the eye indications.
Our lead product candidate, Nyxol® Eye Drops, is a once-daily preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size and improve visual acuity, and is being developed for several indications, including dim light or night vision disturbances, pharmacologically-induced mydriasis, and presbyopia. Nyxol is an investigational 505(b)(2) product candidate that has been dosed in over 150 patients across 7 completed Phase 1 and 2 trials.
Our second product candidate, APX3330, is a twice-a-day oral tablet, designed to inhibit angiogenesis and inflammation pathways relevant to retinal and choroidal vascular diseases, such as diabetic retinopathy and diabetic macular edema. APX3330 has been dosed in over 340 patients across 11 Phase 1 and Phase 2 trials.
We plan to initiate two Phase 3 registration trials and two Phase 2 trials across four ophthalmic indications in the fourth quarter of 2020 through the first quarter 2021. As part of our strategy, we will continue to explore opportunities to acquire additional ophthalmic assets and to seek strategic partners for late stage development, regulatory preparation and commercialization of drugs in key global markets.