Ocuphire Publishes Phase 3 Trial Results of Ryzumvi for Reversal of Pharmacologically-Induced Mydriasis

Ocuphire Pharma announced the full results from two pivotal phase 3 clinical trials (MIRA-2 and MIRA-3) that evaluated the safety and efficacy of Ryzumvi (phentolamine ophthalmic solution 0.75%) for reversing pharmacologically-induced mydriasis. The data were published in the peer-reviewed journal Ophthalmology.

The trials demonstrated that phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist, rapidly and effectively reversed drug-induced pupil dilation with a favorable safety profile, according to Ocuphire.

Key Findings from the Phase 3 Trials

The MIRA-2 and MIRA-3 studies both met their primary endpoints, showing that a significantly higher percentage of subjects treated with phentolamine ophthalmic solution 0.75% achieved reversal of mydriasis at 90 minutes compared to those receiving placebo.

• In the MIRA-2 trial, 48.9% of subjects treated with phentolamine ophthalmic solution 0.75% achieved reversal compared to 6.6% in the placebo group (P<0.0001).
• In the MIRA-3 trial, 58% of treated subjects met the primary endpoint compared to 6% of the placebo group (P<0.0001).

The effects were observed as early as 60 minutes post-administration and were maintained for up to 24 hours. Additionally, fewer subjects in the treatment group experienced residual dilation 24 hours post-dilation (8-11%) compared to placebo-treated subjects (28-34%).

The most common treatment-related adverse events included mild and transient conjunctival hyperemia (11.2%), instillation site discomfort (10.9%), and dysgeusia (3.6%).

The FDA approved Ryzumvi in September 2023. 

Beyond mydriasis, phentolamine ophthalmic solution 0.75% is under evaluation for other indications, including presbyopia and dim light vision disturbances (DLD) following keratorefractive surgery. Ocuphire’s VEGA-3 phase 3 trial for presbyopia is actively enrolling, with topline data expected in the first half of 2025. The LYNX-2 trial for DLD is also underway, with results anticipated in early 2025.