Ocuphire Pharma Publishes Full Phase 3 Results for Phentolamine Ophthalmic Solution 0.75% in Ophthalmology

Ocuphire Pharma, Inc., a clinical-stage biopharmaceutical company specializing in ophthalmic treatments, has released comprehensive data from two pivotal Phase 3 clinical trials, MIRA-2 and MIRA-3. These trials assessed the safety and efficacy of RYZUMVI™ (Phentolamine Ophthalmic Solution 0.75%) for reversing pharmacologically-induced mydriasis. The findings, published in the journal Ophthalmology, revealed that the non-selective alpha-1 and alpha-2 adrenergic antagonist effectively and swiftly counteracted pupil dilation with minimal side effects.

In both trials, Phentolamine Ophthalmic Solution 0.75% significantly outperformed the placebo in reversing mydriasis at the 90-minute mark, the primary endpoint. Specifically, 48.9% of subjects in the MIRA-2 trial and 58% in the MIRA-3 trial achieved pupil diameter reversal compared to only 6.6% and 6% in the placebo groups, respectively. Improvements in pupil size were noted as early as 60 minutes post-administration and persisted up to 24 hours. Additionally, subjects reported a faster resolution of visual symptoms such as photophobia and blurred vision when treated with Phentolamine Ophthalmic Solution 0.75%.

Safety evaluations indicated that the treatment was generally well-tolerated. The most common side effects, including mild conjunctival hyperemia, instillation site discomfort, and dysgeusia, were transient and manageable. The favorable results underscore the potential of Phentolamine Ophthalmic Solution 0.75% to enhance patient experience during routine eye exams by offering quicker recovery from induced mydriasis.

Dr. David Wirta, a principal investigator in these trials, remarked on the significance of the results, highlighting how they substantiate the scientific rationale behind Phentolamine Ophthalmic Solution 0.75% and its approval by the FDA for this use. The acceptance of the study in a leading ophthalmology journal further validates the importance of these findings for patient care.

RYZUMVI™ is now approved for treating pharmacologically-induced mydriasis initiated by adrenergic agonists like phenylephrine or parasympatholytic agents such as tropicamide. The solution is also under investigation for additional ophthalmic conditions, including presbyopia and visual disturbances under low light conditions post-keratorefractive surgery. Ongoing Phase 3 trials, VEGA-3 for presbyopia and LYNX-2 for dim light vision disturbances, are actively enrolling, with top-line data expected in early 2025.

Ocuphire's commitment extends beyond mydriasis, focusing on advancing Phentolamine Ophthalmic Solution 0.75% for broader applications. The company’s ongoing trials aim to establish its efficacy in treating presbyopia and low-light vision issues, building on the successful outcomes of earlier Phase 2 and Phase 3 studies.

The MIRA-2 and MIRA-3 clinical trials were extensive, involving 553 healthy participants aged 12 to 80 years. These randomized, double-masked, placebo-controlled, multi-center studies examined the response to Phentolamine Ophthalmic Solution 0.75% following mydriasis induced by agents such as phenylephrine and tropicamide. The key endpoint was the percentage of subjects whose pupil diameter returned to within 0.2 mm of baseline within 90 minutes post-treatment, with follow-ups extending to 24 hours.

Pharmacologically-induced mydriasis is common in the U.S., with approximately 100 million eye dilations conducted annually. The condition causes temporary pupil dilation, leading to sensitivity to light and blurred vision, which can impede daily activities. Phentolamine Ophthalmic Solution 0.75% addresses this need by providing a quick and effective solution to restore normal pupil size.

Ocuphire Pharma continues to spearhead the development of innovative therapies for eye disorders, with Phentolamine Ophthalmic Solution 0.75% at the forefront of its offerings. The company is dedicated to improving patient outcomes through rigorous clinical research and strategic partnerships.