🇺🇸 Miebo in United States

FDA authorised Miebo on 18 May 2023 · 1,377 US adverse-event reports

Marketing authorisations

FDA — authorised 18 May 2023

  • Application: NDA216675
  • Marketing authorisation holder: BAUSCH AND LOMB INC
  • Local brand name: MIEBO
  • Indication: SOLUTION/DROPS — OPHTHALMIC
  • Status: approved

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FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Eye Pain — 194 reports (14.09%)
  2. Vision Blurred — 177 reports (12.85%)
  3. Eye Irritation — 167 reports (12.13%)
  4. Inappropriate Schedule Of Product Administration — 161 reports (11.69%)
  5. Product Delivery Mechanism Issue — 140 reports (10.17%)
  6. Product Use Issue — 130 reports (9.44%)
  7. Ocular Hyperaemia — 108 reports (7.84%)
  8. Circumstance Or Information Capable Of Leading To Medication Error — 106 reports (7.7%)
  9. Product Use Complaint — 101 reports (7.33%)
  10. Product Complaint — 93 reports (6.75%)

Source database →

Other Ophthalmology approved in United States

Frequently asked questions

Is Miebo approved in United States?

Yes. FDA authorised it on 18 May 2023; FDA has authorised it.

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

BAUSCH AND LOMB INC holds the US marketing authorisation.