MIEBO- perfluorohexyloctane solution

MIEBO by

Drug Labeling and Warnings

MIEBO by is a Prescription medication manufactured, distributed, or labeled by Bausch & Lomb Incorporated, Alliance Medical Products, Inc. (dba Siegfried Irvine). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    MIEBO ®(perfluorohexyloctane ophthalmic solution) is indicated for the treatment of the signs and symptoms of dry eye disease (DED).

  • 2 DOSAGE AND ADMINISTRATION

    2.1 Recommended Dosage

    Instill one drop of MIEBO four times daily into affected eye(s).

    Contact lenses should be removed prior to and for at least 30 minutes after the administration of MIEBO.

    2.2 Administration Instructions

                               Step 1.Remove the cap from eye drop bottle.

    Step 2.Step 2.Holding the bottle upright, gently squeeze the bottle.

    Step 3.Step 3.While squeezing, turn the bottle upside down and release the pressure (drawing air into the bottle).

    Step 4.Step 4.Keeping the bottle upside down, place the bottle above your eye and squeeze it again to release a drop into your eye.

    Repeat steps 1 – 4 for the second affected eye.

  • 3 DOSAGE FORMS AND STRENGTHS

    MIEBO (perfluorohexyloctane ophthalmic solution) is a sterile, clear and colorless ophthalmic solution containing 100% perfluorohexyloctane.

  • 4 CONTRAINDICATIONS

    None.

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Use with Contact Lenses

    MIEBO should not be administered while wearing contact lenses. Advise patients that contact lenses should be removed prior to and for at least 30 minutes after administration of MIEBO.

  • 6 ADVERSE REACTIONS

    6.1 Clinical Trials Experience

    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

    In patients with DED, 614 patients received at least one dose of MIEBO in two randomized controlled clinical trials across 68 sites in the United States. The most common ocular adverse reaction was blurred vision. Blurred vision and conjunctival redness were reported in 1-3% of individuals.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Risk Summary

    There are no adequate and well controlled studies with MIEBO in pregnant women.

    In animal reproduction studies with oral administration of perfluorohexyloctane during the period of organogenesis, no adverse maternal or developmental effects were observed in rats at doses up to 162 times the recommended human ophthalmic dose (RHOD) ( see Data). Maternal toxicity, miscarriages and reduced fetal weights were observed in rabbits at all doses tested, with the lowest dose as 41 times the RHOD.

    All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects is 2 to 4%, and of miscarriage is 15 to 20%, of clinically recognized pregnancies.

    Data

    Animal Data

    An embryofetal study was conducted in pregnant rabbits administered perfluorohexyloctane by oral gavage on gestation days 6 to 19, to target the period of organogenesis. Perfluorohexyloctane produced maternal toxicity, characterized by reduced body weight gain and food consumption, and miscarriages at all doses tested, with the lowest dose as ≥ 250 mg/kg/day (41 times the RHOD based on body surface area). Reduced fetal weights were also observed at ≥ 250 mg/kg/day but no fetal mortality or malformations. A no observed adverse effect level (NOAEL) for maternal toxicity was not established in rabbits.

    An embryofetal study was conducted in pregnant rats administered perfluorohexyloctane by oral gavage on gestation days 6 to 17, to target the period of organogenesis. There was no evidence of embryofetal toxicity or teratogenicity at doses up to 2,000 mg/kg/day (162 times the RHOD).

    8.2 Lactation

    There are no data on the presence of perfluorohexyloctane in human milk, the effects on the breastfed infant, or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of MIEBO to an infant during lactation; however, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for MIEBO.

    8.4 Pediatric Use

    The safety and effectiveness of MIEBO in pediatric patients below the age of 18 years have not been established.

    8.5 Geriatric Use

    No overall differences in safety and effectiveness have been observed between elderly and younger patients.

  • 11 DESCRIPTION

    MIEBO ®(perfluorohexyloctane ophthalmic solution) is a sterile, clear and colorless liquid containing 100% perfluorohexyloctane, for topical ophthalmic use.

    The active ingredient is 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorotetradecane and is a semifluorinated alkane. It has a molecular formula of C 14H 17F 13and a molecular weight of 432.26 g/mol. The chemical structure is:

    chemstructure

    Perfluorohexyloctane is practically immiscible with water. It is miscible with ethanol and most

    organic solvents. Each multiple-dose bottle contains 3 mL of perfluorohexyloctane, 1.338 g/mL as a clear and colorless liquid.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    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.

    12.3 Pharmacokinetics

    The pharmacokinetics of perfluorohexyloctane following topical ocular administration of MIEBO has not been quantitatively characterized in humans. A single pharmacokinetic (PK) study was conducted that showed low systemic perfluorohexyloctane blood levels after topical ocular administration. Perfluorohexyloctane was not metabolized by human liver microsomes in vitro.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of perfluorohexyloctane.

    Perfluorohexyloctane was not mutagenic or clastogenic in a standard battery of genotoxicity tests, including a bacterial mutagenicity assay (Ames assay), an in vitro chromosome aberration assay using human peripheral lymphocytes, and an in vivo bone marrow micronucleus assay in rats.

  • 14 CLINICAL STUDIES

    In two randomized, multicenter, double-masked, saline-controlled trials (GOBI and MOJAVE), a total of 1,217 patients with a history of DED and clinical signs of meibomian gland dysfunction were randomized to MIEBO or saline 0.6% (1:1 ratio) to evaluate safety and efficacy after receiving MIEBO four times daily (QID) for 57 days.The mean age of the 614 patients who received MIEBO was 57 years (range, 19-87 years). The majority of patients were female (76%).

    Effects on Signs of Dry Eye Disease

    Total corneal fluorescein staining (tCFS) was recorded at each study visit using a standardized grading system of 0-3 for each of the five areas on the cornea (inferior, superior, central, nasal, and temporal), totaling a maximum tCFS score for each eye of 15. The average baseline tCFS was approximately 6.7 in GOBI and 7.0 in MOJAVE. At Days 15 and 57, a statistically significant reduction in tCFS favoring MIEBO was observed in both studies (Figure 1).

    Table

Description automatically generated

    Effects on Symptoms of Dry Eye Disease

    Eye dryness score was rated by patients using a visual analogue scale (VAS) (0=no discomfort, 100=maximal discomfort) at each study visit. The baseline VAS eye dryness average score was approximately 67 in GOBI and 65 in MOJAVE. At Days 15 and 57, a statistically significant reduction in VAS eye dryness score favoring MIEBO was observed in both studies (Figure 2).

    Table

Description automatically generated
  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    MIEBO ®(perfluorohexyloctane ophthalmic solution) is supplied as a sterile, clear and colorless liquid in multiple-dose 5 mL polypropylene bottles with dropper tips and screw caps, packaged in a carton - NDC: 24208-377-05.

    Storage

    Store MIEBO at 15ºC to 25ºC (59ºF to 77ºF). After opening, MIEBO can be used until the expiration date on the bottle.

  • 17 PATIENT COUNSELING INFORMATION

    Use with Contact Lenses

    Advise patients that contact lenses should be removed prior to and for at least 30 minutes after administration of MIEBO.

    Administration Instructions

    Advise patients to instill one drop of MIEBO four times daily into each eye as depicted in the Administration Instructions [see Dosage and Administration (2.2)] .

    Distributed by:

    Bausch & Lomb Americas Inc.

    Bridgewater, NJ 08807 USA

    Patented. See https://patents.bausch.comfor US patent information.

    MIEBO is a trademark of Bausch & Lomb Incorporated or its affiliates.

    © 2024 Bausch & Lomb Incorporated or its affiliates

    9805300

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    NDC24208-377-05

    Miebo®
    (perfluorohexyloctane
    ophthalmic solution)

    For Topical
    Ophthalmic Use

    Multiple-dose

    container

    Sterile

    Rx only

    3 mL

    9805201

    SP63005

    carton
  • INGREDIENTS AND APPEARANCE
    MIEBO 
    perfluorohexyloctane solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 24208-377
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PERFLUOROHEXYLOCTANE (UNII: 7VYX4ELWQM) (PERFLUOROHEXYLOCTANE - UNII:7VYX4ELWQM) PERFLUOROHEXYLOCTANE1 mg  in 1 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 24208-377-051 in 1 CARTON05/18/2023
    13 mg in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC: 24208-377-011 in 1 CARTON05/18/2023
    23 mg in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC: 24208-377-061 in 1 CARTON07/19/2024
    31.6 mg in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21667505/18/2023
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alliance Medical Products, Inc. (dba Siegfried Irvine)102688657manufacture(24208-377)

  • Trademark Results [MIEBO]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MIEBO
    MIEBO
    97424093 not registered Live/Pending
    Bausch + Lomb Ireland Limited
    2022-05-23
    MIEBO
    MIEBO
    90360371 not registered Live/Pending
    Bausch + Lomb Ireland Limited
    2020-12-04

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