EyePoint Pharmaceuticals, Inc.

[intro music] EyePoint Pharmaceuticals releases key phase three data for its wet AMD drug Duraview.

Zeiss receives FDA clearance for a cloud and browser-based data management solution.

And the FDA expands Sight Sciences' indications for the TearCare system for the treatment of MGD.

[outro music] Hello, I'm Kendall O'Connor with EyeWire News, the podcast.

Thank you for joining us.

In our top story, in the phase three Lugano trial, EyePoint Pharmaceuticals' wet AMD drug candidate, Duraview, missed the primary non-inferiority endpoint versus on-label aflibercept.

However, the company says an ad hoc analysis excluding nine of 211 patients showed non-inferiority.

The Lugano trial's primary endpoint was non-inferiority in average change from baseline in best-corrected visual acuity at weeks 52 and 56.

For a midsize dermatology specialist without a big pharma balance sheet, that’s the only version of this strategy that survives a miss.

On the regulatory side, the one worth arguing about is EyePoint, and we flagged this readout on July thirtieth.

Monday, Duraview missed its primary endpoint against Eylea on best-corrected visual acuity, and the stock crashed sixty-seven percent.

But read the actual failure.

And for LEO, dersimelagen’s FDA decision is now the whole value trigger.

Two clinical items I’d add.

EyePoint’s Lucia readout this fall carries the entire Duraview thesis, and there’s no hedging it.

And on AstraZeneca, the volrustimig lung trial we covered yesterday died at an interim survival check.

EyePoint spent years telling this industry it could break the injection cycle in wet AMD.

The market believed it.

This morning, the stock crashed sixty-seven percent.

Sixty-seven percent.

That's the whole story in one number.

EyePoint crashed sixty-seven percent Monday after durav you missed its primary endpoint in the Lugano phase III in wet AMD head-to-head against aflibercept.

And what makes today brutal rather than merely bad is what the company did next.

They went to an ad hoc analysis to pull something usable out of the dataset.