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GKOS FDA Decision Approved · 2026-01-28

Page updated October 4, 2026·next FDA decision on the calendar ·Data as of Oct 14, 2026 7:39 PM ET

Price into the decision (T-120)

Daily close, T-120 (8/13/25) through T+5. Run-up high $125.9 on 1/22/26, low $74.67 on 10/30/25 (T-120 to T-1). FDA decision 1/28/26. Historical price action, not a forecast.

Decision facts

FDA decision date2026-01-28

DrugiDose TR

IndicationGlaucoma

Outcome✓ Approvedprimary-sourced

Decision-day move+4.4%

T-120 run-up (low→high)+58.0% ($74.67→$125.9)

ValidationVerified 2026-08-12: Drugs@FDA, application NDA218010, action date 2026-01-27

Market-cap tierMid

Cohort decision-day move (history)2.1% median (n=235)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

See the full 2026 PDUFA calendar →

Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.

Questions

Was iDose TR approved by the FDA?

Yes. The FDA approved the application for iDose TR on January 27, 2026, per the FDA's own record. The company announced it on January 28, 2026. The primary source is linked on this page.

What was iDose TR under FDA review for?

The application covered Glaucoma. The FDA approved the application on January 28, 2026.

How did GKOS stock react to the FDA decision?

On the decision day GKOS moved +4.4%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.