Key takeaways:
- The security profile was constructive and in step with earlier trials.
- Opus Genetics is planning an FDA submission later this 12 months.
Editor’s observe: It is a creating information story. Please verify again quickly for updates.
A second section 3 pivotal medical trial investigating phentolamine ophthalmic resolution 0.75% for the remedy of presbyopia met its major and key secondary endpoints, based on a press launch from Opus Genetics.
“Presbyopia is likely one of the most typical ocular situations. Many sufferers are in search of a noninvasive remedy that doesn’t compromise distance imaginative and prescient or nighttime visible perform,” George Magrath, MD, CEO of Opus Genetics, informed Healio. “The outcomes from VEGA-3 are particularly encouraging. Phentolamine ophthalmic resolution 0.75% not solely met its major and all secondary endpoints however confirmed fast and sustained enchancment in close to visible acuity, with no significant impression on distance imaginative and prescient. That could be a highly effective mixture.”
VEGA-3, a multicenter, randomized, double-masked, placebo-controlled trial, investigated the security and efficacy of phentolamine in 545 individuals randomly assigned 3:2 to remedy with once-daily phentolamine or placebo. The first endpoint was the proportion of individuals that achieved an enchancment of 15 letters or extra in binocular distance corrected close to visible acuity (DCNVA) with a lack of lower than 5 letters of greatest corrected distance visible acuity from baseline at 12 hours after dosing on day 8 vs. placebo.
Based on the discharge, 27.2% of individuals who obtained phentolamine achieved the first endpoint vs. 11.5% of individuals who obtained placebo (P < .0001). Moreover, 20.6% of those that obtained phentolamine achieved an enchancment of 15 letters or extra in DCNVA at 1 hour after dosing on day 1 vs. 6.1% of placebo individuals (P = .0002).
“What stood out to us was the energy of patient-reported outcomes, notably in enchancment in close to imaginative and prescient and satisfaction in close to imaginative and prescient upon awakening [P < .0001 for both],” Magrath informed Healio.
“The security profile was in step with prior research,” based on Magrath, with no critical opposed occasions associated to remedy. Remedy-emergent opposed occasions included conjunctival hyperemia, instillation web site irritation and dysgeusia, all predominantly delicate, the discharge mentioned.
“These findings reinforce the potential of phentolamine’s differentiated, distinctive sympatholytic mechanism of motion that doesn’t interact the ciliary muscle, with the low prevalence of headache of solely 2.6%,” Magrath informed Healio. “We’re focusing on FDA submission within the second half of 2025.”
