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

Marketedupdated 5mo 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

  • phase4BL-RX01-TFSTAB-1402recruitingn=20
  • phase4SYSTANE® PRO vs. MIEBO™ in Dry Eye Diseasecompletedn=269
  • 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
  • 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
~1.6 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)1.6y

News(2)

  • Zepbound may cut healthcare costs, study says; Summit, Akeso drug hits in another China trial
    A real-world study suggests Zepbound use could reduce the rates of hospital stays and ER visits. Elsewhere, McKesson sprung for a multibillion-dollar deal and J&J nabbed a noteworthy approval.
    biopharma_dive · 1mo ago
  • Bausch + Lomb advances dry eye disease drug to Phase 3 despite mid-stage fail
    While Bausch + Lomb’s dual-action eye drops failed to outperform active comparators at day 29, the investigational asset showed significant superiority at day 15.
    biospace · 1mo ago
brand
Miebo
generic
perfluorohexyloctane
indication
Keratoconjunctivitis Sicca (Dry Eye)
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 5h ago
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