Ocuphire Pharma Announces Publication of Full Phase 3 Results of Phentolamine Ophthalmic Solution 0.75% for Pharmacologically-Induced Mydriasis in Ophthalmology

Core Insights - Ocuphire Pharma, Inc. announced the publication of full results from two pivotal Phase 3 clinical trials (MIRA-2 and MIRA-3) for RYZUMVI™ (Phentolamine Ophthalmic Solution 0.75%) demonstrating its efficacy in reversing pharmacologically-induced mydriasis with a favorable safety profile [1][4][10] Group 1: Clinical Trial Results - In the MIRA-2 trial, 48.9% of subjects treated with Phentolamine achieved reversal of mydriasis at 90 minutes compared to 6.6% in the placebo group (p<0.0001) [2] - In the MIRA-3 trial, 58% of subjects treated with Phentolamine achieved the primary endpoint versus 6% in the placebo group (p<0.0001) [2] - Significant improvements in pupil diameter were observed as early as 60 minutes post-administration, with effects lasting up to 24 hours [2][3] Group 2: Safety Profile - The most common treatment-emergent adverse events for Phentolamine were mild and transient, including conjunctival hyperemia (11.2%), instillation site discomfort (10.9%), and dysgeusia (3.6%) [3] - Fewer subjects treated with Phentolamine (8-11%) had residual dilation at 24 hours compared to 28-34% in the placebo group (p<0.0001) [3] Group 3: Future Developments - Phentolamine Ophthalmic Solution 0.75% is being evaluated in ongoing Phase 3 trials for presbyopia (VEGA-3) and dim light vision disturbances (LYNX-2), with top-line data expected in the first half of 2025 [5][10] - The VEGA-3 trial is actively enrolling participants, and the LYNX-2 trial is also in progress [5][10] Group 4: Company Overview - Ocuphire Pharma is focused on developing small molecule therapies for retinal and refractive eye disorders, with RYZUMVI™ being a key late-stage product candidate [1][10] - The company is responsible for managing the ongoing clinical trials and has a partnership for the commercialization of Phentolamine [9][10]