Ryzumvi safely, rapidly reverses pharmacologically-induced mydriasis
Click Here to Manage Email Alerts
Key takeaways:
- Significantly more participants treated with phentolamine ophthalmic solution 0.75% vs. placebo achieved reversal of mydriasis at 60 and 90 minutes.
- Adverse events were mild and transient.
Ryzumvi effectively reduced pharmacologically induced mydriasis within 60 to 90 minutes compared with placebo, while also exhibiting a favorable safety profile, according to results from two studies published in Ophthalmology.
“Routine dilated eye exams are essential for early disease detection, and offering patients faster recovery from mydriasis with minimal side effects enhances the quality of their care,” principal investigator David Wirta, MD, of the Eye Research Foundation in Newport Beach, California, said in a related Ocuphire Pharma press release.
Wirta and colleagues conducted the multicenter, double-masked MIRA-2 and MIRA-3 trials to evaluate the safety and efficacy of Ryzumvi (phentolamine ophthalmic solution 0.75%, Ocuphire/Viatris) for the treatment of pharmacologically induced mydriasis.
They enrolled 553 healthy individuals aged 12 to 80 years, who were randomly assigned 1:1 in MIRA-2 (n = 185) and 2:1 in MIRA-3 (n = 368) to receive phentolamine ophthalmic solution or placebo 1 hour after mydriasis.
The primary outcome of interest was percentage of participants returning to less than or equal to 0.2 mm greater than baseline pupil diameter 90 minutes after treatment. The researchers also assessed safety and tolerability measures.
In MIRA-2, 48.9% of the treatment group achieved reversal at 90 minutes compared with 6.6% in the placebo group (P < .0001), with similar results reported in MIRA-3 (58% vs. 6%; P < .0001).
Notably, 24.5% of treated participants in MIRA-2 and 42% in MIRA-3 achieved reversal at 60 minutes compared with 5.5% and 2% in the respective placebo groups (MIRA-2: P < .0003; MIRA-3: P < .0001).
In addition, fewer participants in the treatment groups (8%-11%) experienced residual dilation at 24 hours after dilation vs. the placebo groups (28%-34%; P < .0001). The safety profile of phentolamine ophthalmic solution was favorable, with transient conjunctival hyperemia (11.2%), instillation site discomfort (10.9%) and dysgeusia (3.6%) among the most common adverse events.
The researchers acknowledged that one potential limitation was that only healthy individuals without systemic or ocular disease were enrolled, noting that “further studies may need to include patients with conditions that could affect pupillary dynamics, such as pseudoexfoliation, diabetes and other conditions that may affect the autonomic nervous system.”
Reference:
- Ocuphire Pharma announces publication of full phase 3 results of phentolamine ophthalmic solution 0.75% for pharmacologically-induced mydriasis in Ophthalmology. https://ir.ocuphire.com/press-releases/detail/443/ocuphire-pharma-announces-publication-of-full-phase-3. Published Sept. 30, 2024. Accessed Oct. 16, 2024.
Collapse
Read more about
Click Here to Manage Email Alerts