Approximately 120 million Americans live with presbyopia, a gradual, age-related loss of the eyes’ ability to focus on nearby objects. And if nothing is done, the global is expected to exceed 150 million by 2034. Unfortunately, there are currently no approved drug therapies for this condition. However, Ocuphire Pharma, Inc. (NASDAQ: OCUP) has taken up the matter to find solutions with a possible treatment for presbyopia.
The clinical-stage ophthalmic biopharmaceutical company develops and commercializes therapies for the treatment of several eye disorders. An evaluation is currently underway for the VEGA-1 Phase 2 clinical trial of Nyxol before moving to Phase 3. The trial evaluates the efficacy and safety of a product profile of a combination kit of Nyxol and LDP.
The Validation of Nyxol as a Potential ‘Best In Class’ Presbyopia Treatment Option
The VEGA-1 Phase 2 clinical trial enrolled 150 subjects at 17 investigational sites. And according to the CEO of Ocuphire Pharma, Mina Sooch, the results were positive. They met both the primary and secondary endpoints. Additional highlights indicate that Nyxol plus LDP showed a favorable safety profile with rapid onset of efficacy at 30 minutes. In addition, there was efficacy in light and dark iris colors and no severe headaches, brow aches, or blurry vision.
“…we believe that Nyxol and LDP is novel in its mechanism of action and could become a leading pharmacological treatment option for presbyopia….” Sooch added. An additional result is reduced dependence on reading glasses, which have several drawbacks, including night vision disturbances, eye strain, and inconvenience.
The Initiation of Phase 3 Trials for Presbyopia in 2022 and other Company Highlights
Building on the recent success of Nyxo from the Phase 2 trial, Ocuphire Pharma says plans are underway to initiate Phase 3 trials for the same by 2022. In March 2021, the company reported positive topline data for MIRA-2, a Phase 3 FDA registration study for RM treatment. A second candidate, APX3330, an oral tablet designed to inhibit angiogenesis, has been studied in 11 Phase 1 and 2 trials. It is currently enrolling subjects in Phase 2 clinical trial in subjects suffering from DR/DME.