Will the FDA approve Opus Genetics' eye drops for presbyopia, the reading-glasses workaround, by Oct 23?
62% of users predicted NO — the community missed this one. 8 predictions cast.
The FDA approved phentolamine ophthalmic solution 0.75% (brand name Ryzumvi) for the treatment of presbyopia in adults on October 16, 2026, ahead of its October 17 target decision date, according to Healio and a Viatris press release. The approval is a supplemental indication: Ryzumvi was already cleared to reverse pharmacologically induced pupil dilation, and the new approval extends its label to presbyopia, the age-related loss of near vision commonly corrected with reading glasses.
The decision rested on Opus Genetics' Phase 3 VEGA-2 and VEGA-3 trials, which the company said met their primary and key secondary endpoints with no treatment-related serious adverse events. The most common side effects were mild and temporary eye redness and application-site irritation. Phentolamine narrows the pupil through alpha-adrenergic receptor blockade, without acting on the eye's focusing muscle.
Viatris holds exclusive U.S. commercialization rights to Ryzumvi under a licensing agreement with Opus Genetics, and the approval triggers a milestone payment to Opus. Viatris said it is still seeking a commercial partner specifically for the presbyopia indication.
Predict Six's community put only 38% odds on approval happening by the deadline, so the majority outlook did not match the eventual outcome.