Perfluorohexyloctane
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2023
- First approval year
- 2023
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Perfluorohexyloctane
- Molecular weight
- 432.26
- Structure (SMILES)
- CCCCCCCCC(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)F
- miebo
- Miebo
- Densiron [(F6H8)
- densiron f6h8
- f6h8
- F6H8
- miebo
- Miebo
- nov 03
- NOV-03
- nov03
- Nov03
- NOV03
- perfluorohexyloctane
- Perfluorohexyloctane
- Perfluorohexyloctane [INN]
- Perfluorohexyloctane [USAN]
- Perfluorohexyloctane [WHO-DD]
- perfluorohexyloctane inn
- Perfluorohexyloctane ophthalmic solution
- perfluorohexyloctane usan
- perfluorohexyloctane who dd
- perfluorohexyloctano
- Perfluorohexyloctano
- CAS registry numbers
- 133331-77-8
- ChEMBL ID
- CHEMBL5314588
- InChIKey
- WRYIIOKOQSICTB-UHFFFAOYSA-N
- PubChem compound IDs
- 10477896
- RxNorm IDs (RxCUI)
- 2637547
- FDA ingredient codes (UNII)
- 7VYX4ELWQM
- Applicant
- BAUSCH AND LOMB INC
- Approval date
- 18 May 2023
- Application number
- NDA216675
- Patents
- 6
- Designations
- 0
- Earliest recorded loss of exclusivity
- 21 Jun 2037
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Drug name stem
- perflu-
Administration routes
- topical
- Condition
- Meibomian Gland Dysfunction
- Highest recorded phase
- 1
- Subject identifier
- D000080343
- Condition
- Retinal Detachment
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005773
- Subject identifier
- D012163
- Condition
- Dry Eye Syndromes
- Highest recorded phase
- 4
- Condition identifier
- EFO:1000906
- Subject identifier
- D015352
- Condition identifier
- EFO_0005773
- Condition identifier
- EFO_1000906
- Condition identifier
- MONDO_0005464
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0006733
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0700115
- Highest recorded phase
- 2
- NCT00403702
- NCT03333057
- NCT04139798
- NCT04140227
- NCT04567329
- NCT05723770
- NCT06309953
- NCT06346340
- Dose
- One drop
- Route
- Eye drops
- How often
- Four times daily
Conditions of use
- Contact lenses should be removed prior to and for at least 30 minutes after administration
- Hydrogen bond acceptors
- 0
- Hydrogen bond donors
- 0
- Polar surface area
- 0
- Calculated partition coefficient (ALogP)
- 7.48
- Calculated partition coefficient (XLogP)
- 8.7
- Prodrug
- No
- Chirality
- Achiral
- Inorganic
- No
- Rule-of-five violations
- 1
- Rotatable bonds
- 11
- Heavy atoms
- 27
- Molecular formula
- C14H17F13
- Monoisotopic mass
- 432.1122666
- Natural product
- No
- 24208-377
Related records
Trials (18)
- A Multicenter, Open-Label Study to Evaluate Perioperative Treatment of Dry Eye With Miebo® in Subjects Undergoing LASIK
- A Single Center, Open-Label Study to Evaluate the Ability of the TearScience™ LipiView™ II Ocular Surface Interferometer and the Keratograph® 5M to Detect Tear Film Stability Utilizing Miebo®
- A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease
- A Study to Assess the Long-Term Safety of Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination in Subjects With Dry Eye Disease
- A Study to Evaluate Concomitant Perfluorohexyloctane Use With Contact Lens Wear
- A Study to Evaluate Corneal Endothelial Cell Density (ECD) in Subjects With Dry Eye Disease (DED) Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months.
- A Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease
- A Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/Keratometry and Postoperative Refractive Accuracy
- BL-RX01-TFSTAB-1402
- Comparison High-density Silicone Oils in Retinal Detachment
- Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study)
- Effects of NOV03 on the Tear Film
- Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers
- Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)
- Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)
- Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
- Perfluorohexyloctane Eye Drops vs. Sodium Hyaluronate for Video Display Terminal-Associated Dry Eye
- SYSTANE® PRO vs. MIEBO™ in Dry Eye Disease
Approved for (1)
In development for (1)
- Retinal detachment Phase 2