For those following the journey, the AI overlords are taking another crack at a prediction (
#3). This is what it's saying:
$IRD — Oct. 17 PDUFA: Phentolamine 0.75% for presbyopia
Approval odds: ~50%
Modeled equity impact: +2.5% approval / −7.4% CRL
Why the coin toss? Both trials hit primary + key secondary endpoints with strong statistical significance and no treatment-related SAEs. It’s also the same 0.75% formulation already approved as RYZUMVI.
But the absolute efficacy is modest: ~73% of treated patients still didn't achieve the ≥3-line improvement at 12 hours, despite p<0.0001. Add a fourth-entrant market (VIZ, QLosi, VUITY) and Viatris controlling the filing, launch and prioritization, and I’m keeping it around a coin flip.
Separate risk: even with approval, label breadth/duration could materially change the royalty opportunity.
Downside > upside because some success is already priced in, while a CRL removes near-term royalty/milestone value, delays cash flows and increases financing pressure.
Let's see what happens 👀