🇺🇸 Dexycu in United States

FDA authorised Dexycu on 9 February 2018 · 314 US adverse-event reports

Marketing authorisations

FDA — authorised 9 February 2018

  • Application: NDA208912
  • Marketing authorisation holder: EYEPOINT PHARMS
  • Status: approved

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. Device Dislocation — 84 reports (26.75%)
  2. Corneal Oedema — 62 reports (19.75%)
  3. Iris Atrophy — 38 reports (12.1%)
  4. Pupillary Deformity — 29 reports (9.24%)
  5. Product Residue Present — 28 reports (8.92%)
  6. Eye Colour Change — 15 reports (4.78%)
  7. Intraocular Pressure Increased — 15 reports (4.78%)
  8. Off Label Use — 15 reports (4.78%)
  9. No Adverse Event — 14 reports (4.46%)
  10. Visual Impairment — 14 reports (4.46%)

Source database →

Dexycu in other countries

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

Other Other approved in United States

Frequently asked questions

Is Dexycu approved in United States?

Yes. FDA authorised it on 9 February 2018; FDA has authorised it.

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

EYEPOINT PHARMS holds the US marketing authorisation.