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  1. pharmadog
  2. ›drugs
  3. ›Miebo
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perfluorohexyloctane

Marketedupdated 3mo ago
by $BLCO Bausch & Lomb Corp
Approved
community read0 votes

🐶 often sniffed alongside

top 1
  • tagApproval8 co-mentions · 2 sources

all catalysts(0)

nothing on the calendar yet

Trials studying perfluorohexyloctane

  • phase2A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Diseasecompletedn=443
  • phase4A Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/Keratometry and Postoperative Refractive Accuracycompletedn=97
  • phase4SYSTANE® PRO vs. MIEBO™ in Dry Eye Diseaserecruitingn=260
  • phase4A Study to Evaluate Concomitant Perfluorohexyloctane Use With Contact Lens Wearcompletedn=104
  • phase3A Study to Assess the Long-Term Safety of Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination in Subjects With Dry Eye Diseasewithdrawn
  • phase4A Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Diseasecompletedn=99
  • phase4A Study to Evaluate Corneal Endothelial Cell Density (ECD) in Subjects With Dry Eye Disease (DED) Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months.active not recruitingn=216

Patent cliff

source: FDA Orange Book
first barrier falls
May 18, 2028
~1.8 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (6)

  • Jun 21, 2037method-of-use (U-1900)US 10507132
  • Sep 29, 2036formulationUS 11357738
  • Oct 1, 2035method-of-use (U-1900)US 10576154
  • Sep 12, 2033method-of-use (U-1900)US 10058615
  • Sep 12, 2033method-of-use (U-1900)US 10369117
  • Sep 12, 2033method-of-use (U-1900)US 10449164

FDA exclusivities (1)

  • May 18, 2028NCENew Chemical Entity (5y)1.8y

News(0)

no news has mentioned this drug yet

brand
Miebo
generic
perfluorohexyloctane
indication
Keratoconjunctivitis Sicca (Dry Eye)
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 13m ago
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