Ocuphire Pharma, Inc. engages in the research and development of ophthalmic biopharmaceutical products. It focuses on developing and commercializing therapies for the treatment of several eye disorders. The company was founded by Mina Patel Soouch and Alan R. Meyer in February 2018 and is headquartered in Farmington Hills, MI.
Clinical Trials
14
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2018
Completed
13
92.9%
Recruiting
1
7.1%
No approval data available
• Clinical trials are actively progressing for Fabry Disease, with companies like Idorsia and Sanofi Genzyme developing novel therapies. • Emerging treatments like Venglustat and Pegunigalsidase alfa are expected to significantly impact the Fabry Disease market in the coming years. • Research and development efforts are also focused on Clostridium Difficile Infections, with Vedanta Biosciences leading Phase 3 trials for VE303. • Mydriasis treatments are advancing, with companies like Eyenovia exploring solutions like MYDCOMBI for pupil dilation.
- Ocuphire Pharma has acquired Opus Genetics in an all-stock transaction, with the combined company renamed Opus Genetics, Inc., focusing on inherited retinal diseases. - The acquisition expands the pipeline to include AAV-based gene therapies for IRDs and phentolamine ophthalmic solution for presbyopia, while seeking a partner for diabetic retinopathy program. - OPGx-LCA5, a gene therapy for LCA5, shows promising early Phase 1/2 data with visual improvements in patients, and pediatric enrollment is expected in early 2025. - The merger extends the company's cash runway into 2026, anticipating key clinical milestones, including data readouts from multiple Phase 1/2 and Phase 3 trials.
- Phentolamine ophthalmic solution 0.75% (Ryzumvi) significantly reversed pharmacologically-induced mydriasis in MIRA-2 and MIRA-3 Phase 3 trials. - A statistically significant percentage of subjects achieved mydriasis reversal at 90 minutes compared to placebo (p < 0.0001) in both trials. - The solution exhibited a favorable safety profile, with mild and transient adverse events, offering faster recovery from mydriasis. - Ryzumvi, already FDA-approved for mydriasis, is also being evaluated for presbyopia and dim light vision disturbances.
- Ocuphire Pharma has dosed the first patient in its Phase 3 VEGA-3 clinical trial evaluating phentolamine ophthalmic solution 0.75% for presbyopia. - Phentolamine ophthalmic solution 0.75% is under development as a non-invasive alternative to traditional presbyopia treatments. - The VEGA-3 trial (NCT06542497) aims to assess the efficacy and safety of this novel ophthalmic solution.
- Ocuphire Pharma has dosed the first patient in its Phase 3 VEGA-3 clinical trial evaluating phentolamine ophthalmic solution 0.75% for presbyopia. - The VEGA-3 trial is a randomized, double-masked, placebo-controlled study involving 545 participants, with top-line data expected in 2025. - Phentolamine ophthalmic solution 0.75% aims to provide a non-invasive alternative to traditional corrective measures for presbyopia. - Ocuphire anticipates using VEGA-3 data to support a supplemental New Drug Application with the FDA.
