🇺🇸 Tryptyr in United States

FDA authorised Tryptyr on 28 May 2025

Marketing authorisations

FDA — authorised 28 May 2025

Application: NDA217370
Marketing authorisation holder: ALCON LABS INC
Local brand name: TRYPTYR
Indication: SOLUTION/DROPS — OPHTHALMIC
Status: approved

The FDA approved Tryptyr, a new molecular entity, on 28 May 2025. The marketing authorisation holder is ALCON LABS INC. Tryptyr was approved under the standard expedited pathway. The indication approved for Tryptyr is Type 1, which is a new molecular entity.

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FDA

Marketing authorisation holder: ALCON LABS INC
Status: approved

Tryptyr in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Ophthalmology approved in United States

Frequently asked questions

Is Tryptyr approved in United States?

Yes. FDA authorised it on 28 May 2025; FDA has authorised it.

Who is the marketing authorisation holder for Tryptyr in United States?

ALCON LABS INC holds the US marketing authorisation.