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perfluorohexyloctane 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| perfluorinated compounds used as blood substitutes and/or diagnostic agents | 5730 | 133331-77-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Perfluorohexyloctane, a semifluorinated alkane, contains 6 perfluorinated carbon atoms and 8 hydrogenated carbon atoms. Perfluorohexyloctane forms a monolayer at the air-liquid interface of the tear film which can be expected to reduce evaporation. The exact mechanism of action for MIEBO in DED is not known.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,ACVRL1,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,IKBKB,ITK,JAK2,JAK3,KDR,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MET,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PIK3CG,PIM2,PLK1,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 | 57 | |||
| kinase-selectivity-class | AXL,GRK2,PDK2 | 3 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 18, 2023 | FDA | BAUSCH AND LOMB INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Eye irritation | 155.46 | 52.10 | 36 | 455 | 33942 | 90594014 |
| Eye pain | 92.10 | 52.10 | 25 | 466 | 44143 | 90583813 |
| Vision blurred | 77.21 | 52.10 | 27 | 464 | 110266 | 90517690 |
| Ocular hyperaemia | 55.97 | 52.10 | 16 | 475 | 33782 | 90594174 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Eye irritation | 102.46 | 48.59 | 23 | 315 | 33429 | 110555532 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| FDA EPC | N0000194071 | Semifluorinated Alkane |
| FDA EXT | N0000194072 | Semifluorinated Alkane |
| CHEBI has role | CHEBI:38828 | nonionic surfactant |
| CHEBI has role | CHEBI:66981 | ophthalmology drug |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Dry eye disease | indication | 46152009 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 1.338GM/ML | MIEBO | BAUSCH AND LOMB INC | N216675 | May 18, 2023 | RX | SOLUTION/DROPS | OPHTHALMIC | 10058615 | Sept. 12, 2033 | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
| 1.338GM/ML | MIEBO | BAUSCH AND LOMB INC | N216675 | May 18, 2023 | RX | SOLUTION/DROPS | OPHTHALMIC | 10369117 | Sept. 12, 2033 | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
| 1.338GM/ML | MIEBO | BAUSCH AND LOMB INC | N216675 | May 18, 2023 | RX | SOLUTION/DROPS | OPHTHALMIC | 10449164 | Sept. 12, 2033 | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
| 1.338GM/ML | MIEBO | BAUSCH AND LOMB INC | N216675 | May 18, 2023 | RX | SOLUTION/DROPS | OPHTHALMIC | 10576154 | Oct. 1, 2035 | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
| 1.338GM/ML | MIEBO | BAUSCH AND LOMB INC | N216675 | May 18, 2023 | RX | SOLUTION/DROPS | OPHTHALMIC | 10507132 | June 21, 2037 | TREATMENT OF THE SIGNS AND SYMPTOMS OF DRY EYE DISEASE (DED) |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 1.338GM/ML | MIEBO | BAUSCH AND LOMB INC | N216675 | May 18, 2023 | RX | SOLUTION/DROPS | OPHTHALMIC | May 18, 2028 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| CHEBI:229658 | CHEBI |
| CHEMBL5314588 | ChEMBL_ID |
| C118616 | MESH_SUPPLEMENTAL_RECORD_UI |
| 42638511000001106 | SNOMEDCT_US |
| 4042329 | VANDF |
| C0766224 | UMLSCUI |
| 12751 | INN_ID |
| 10477896 | PUBCHEM_CID |
| 367213 | MMSL |
| 41537 | MMSL |
| 017820 | NDDF |
| D12604 | KEGG_DRUG |
| 7VYX4ELWQM | UNII |
| 2637547 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| MIEBO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24208-377 | SOLUTION | 1 mg | OPHTHALMIC | NDA | 23 sections |
| MIEBO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24208-377 | SOLUTION | 1 mg | OPHTHALMIC | NDA | 23 sections |