Partners Opus Genetics and Viatris reported positive topline results from the Phase III VEGA-3 trial, demonstrating that phentolamine ophthalmic solution 0.75% significantly improved near vision in presbyopia patients. The study met its primary endpoint, with 27.2% of treated participants achieving ≥15-letter improvement in near visual acuity versus 11.5% on placebo (p<0.0001), while maintaining distance vision. Key secondary endpoints, including rapid efficacy at one hour post-dose and sustained benefits through six weeks, were also met with no serious adverse events reported.

The randomised, double-masked trial enrolled 545 participants across 40 US sites. Opus plans to submit a new drug application (NDA) in its US homeland in late 2025.

Phentolamine works by selectively blocking iris dilator muscles without affecting ciliary muscle function. Presbyopia, affecting over 2 billion globally, causes age-related near-vision loss typically requiring reading glasses. Viatris holds exclusive US commercialisation rights under a licensing agreement.

Sources:
[1] Opus Genetics Announces VEGA-3 Phase 3 Trial Met its Primary Endpoint for Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia. https://ir.opusgtx.com/press-releases/detail/490/opus-genetics-announces-vega-3-phase-3-trial-met-its-primary-endpoint-for-phentolamine-ophthalmic-solution-0-75-for-the-treatment-of-presbyopia
[2] Viatris Announces Positive Top-Line Results from Second Pivotal Phase 3 VEGA-3 Trial of MR-141 in Presbyopia. https://investor.viatris.com/news-releases/news-release-details/viatris-announces-positive-top-line-results-second-pivotal-phase