BRIEF SUMMARY-

PERFLUORHEXYLOCTANE- (May 2023)

Indication-   To treat signs and symptoms of dry eye                                                                          disease

Dosage- Instill one drop of MIEBO four times daily into each eye.  Ophthalmic solution: 100% perfluorohexyloctane.

ADR-  Most common ocular adverse reaction was blurred vision. Blurred vision was reported in less than 4% of individuals.

CI-  None. 

Pat inform  Advise patients to instill one drop of MIEBO four times daily into each eye

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U.S.  APPROVED DRUGS DURING 2023                                        

Serial No 17

Name-                      MIEBO

Active  Ingredient -  Perfluorhexyloctane

 Pharmacological clssificiation-      To treat signs and symptoms of dry eye                                                                          disease                                                                                                                                                                                                                    Date of Approval-         5/18/2023 

 HIGHLIGHTS OF PRESCRIBING INFORMATION -

These highlights do not include all the information needed to use                                          MIEBO safely and effectively.

See full prescribing information for MIEBO. MIEBO™ (perfluorohexyloctane ophthalmic solution), for topical ophthalmic use

Initial U.S. Approval: 2023

INDICATIONS AND USAGE-

 MIEBO (perfluorohexyloctane ophthalmic solution) is a semifluorinated alkane indicated for treatment of the signs and symptoms of dry eye disease.

DOSAGE AND ADMINISTRATION-

 Instill one drop of MIEBO four times daily into each eye. 

ADVERSE REACTIONS-

 Most common ocular adverse reaction was blurred vision. Blurred vision was reported in less than 4% of individuals.

CONTRAINDICATIONS

 None. 

DOSAGE AND ADMINISTRATION-

 Instill one drop of MIEBO four times daily into each eye. 

DOSAGE FORMS AND STRENGTHS-

 Ophthalmic solution: 100% perfluorohexyloctane.

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.].

Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Patented. See https://patents.bausch.com for US patent information. MIEBO is a trademark of Bausch & Lomb Incorporated or its affiliates. © 2023 Bausch & Lomb Incorporated or its affiliate

CLINICAL PHARMACOLOGY-

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.

2 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.

USE IN SPECIFIC POPULATIONS

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) 

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.

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.

4. Geriatric Use-

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