Ocuphire Pharma announced the publication of 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 the treatment of pharmacologically induced mydriasis in Ophthalmology. The results demonstrated that Phentolamine Ophthalmic Solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist, rapidly and effectively reversed pharmacologically induced pupil dilation with a favorable safety profile, the company said in a press release. 

As previously reported by Ocuphire, in both trials a statistically significant greater percentage of subjects treated with Phentolamine Ophthalmic Solution 0.75% achieved reversal of pharmacologically induced mydriasis at 90 minutes compared to those receiving placebo, which was the primary endpoint. In the MIRA-2 trial, 48.9% of subjects treated with Phentolamine Ophthalmic Solution 0.75% achieved reversal vs 6.6% in the placebo group (p<0.0001). In the MIRA-3 trial, 58% of subjects treated with Phentolamine Ophthalmic Solution 0.75% achieved the primary endpoint vs 6% in the placebo group (p<0.0001).

Effects were observed as early as 60 minutes following administration, with significant improvements in pupil diameter at that timepoint and at every timepoint measured up to 24 hours following administration in both trials, the company said. More subjects receiving Phentolamine Ophthalmic Solution 0.75% reported a perceived benefit in the resolution of visual symptoms caused by pharmacologically induced mydriasis compared to placebo, with statistically significant differences noted as early as one hour following administration.

Fewer subjects treated with Phentolamine Ophthalmic Solution 0.75% (8-11%) had residual dilation at 24 hours post-dilation, compared to placebo-treated subjects (28-34%) (p<0.0001). Phentolamine Ophthalmic Solution 0.75% exhibited a favorable safety profile, with the most common treatment-emergent adverse events being mild and transient, including conjunctival hyperemia (11.2%), instillation site discomfort (10.9%) and dysgeusia (3.6%).

Phentolamine Ophthalmic Solution 0.75% is currently being evaluated in presbyopia and dim (mesopic) light vision disturbances after keratorefractive surgery, the company said. The VEGA-3 Phase 3 clinical trial for presbyopia is actively enrolling, and top-line data are expected in the first half of 2025. The LYNX-2 Phase 3 trial in patients with decreased visual acuity under low light conditions following keratorefractive surgery is also actively enrolling, and top-line data are expected in the first quarter of 2025.