Perfluorohexyloctane

Overview

Perfluorohexyloctane is a semifluorinated alkane that contains six perfluorinated carbon atoms and eight hydrogenated carbon atoms. It is an inert, slightly amphiphilic compound. Because it is a completely non-aqueous liquid, microbial growth is not possible; therefore, its drug products do not need to be combined with any preservative. Perfluorohexyloctane has been used in the field of ophthalmology as a vitreous substitute. It was approved by the FDA on May 18, 2023 for the treatment of dry eye disease.

Indication

Perfluorohexyloctane ophthalmic formulation is indicated for the treatment of the signs and symptoms of dry eye disease.

Associated Conditions

Dry Eye Syndrome (DES)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Evaluate Corneal Endothelial Cell Density (ECD) in Subjects With Dry Eye Disease (DED) Administering Miebo® (Perfluorohexyloctane Ophthalmic Solution) for 12 Months.	2024/08/22	NCT06565650	Phase 4	Active, not recruiting	Bausch & Lomb Incorporated
A Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/Keratometry and Postoperative Refractive Accuracy	2024/04/04	NCT06346340	Phase 4	Completed	Bausch & Lomb Incorporated
A Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease	2024/03/13	NCT06309953	Phase 4	Completed	Bausch & Lomb Incorporated
Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers	2023/12/20	NCT06176651	Phase 4	Completed	Gordon Schanzlin New Vision
Effects of NOV03 on the Tear Film	2023/02/13	NCT05723770	Phase 4	Completed	Bausch & Lomb Incorporated
Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study)	2020/09/28	NCT04567329	Phase 3	Completed	Bausch & Lomb Incorporated
Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)	2019/10/25	NCT04139798	Phase 3	Completed	Bausch & Lomb Incorporated
Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)	2019/10/25	NCT04140227	Phase 3	Completed	Bausch & Lomb Incorporated
Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)	2017/11/06	NCT03333057	Phase 2	Completed	Novaliq GmbH

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
MIEBO	Bausch & Lomb Incorporated	24208-377	OPHTHALMIC	1 mg in 1 mg	1/1/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

Perfluorohexyloctane Shows Unprecedented Rapid Relief for Dry Eye Disease in Phase 4 Study

2 months ago

A phase 4 multicenter study demonstrated that perfluorohexyloctane (MIEBO) provides significant dry eye symptom relief within just 5 minutes of application, showing nearly 50% improvement that continued to increase at subsequent timepoints.

Miebo Shows Rapid Relief for Dry Eye Disease Within Minutes of First Use, Phase 4 Study Reveals

4 months ago

Bausch + Lomb's Miebo (perfluorohexyloctane ophthalmic solution) demonstrated significant symptom relief within 5 minutes of first application, with effects continuing to improve over 14 days of treatment.

Miebo and Xdemvy Show Strong First-Year Performance in Treating Dry Eye Disease and Demodex Blepharitis

7 months ago

• Miebo (perfluorohexyloctane ophthalmic solution) achieved approximately $162.6 million in sales in its first full year, with 18,000 eye doctors prescribing it, demonstrating strong market acceptance for dry eye disease treatment. • Xdemvy (lotilaner ophthalmic solution 0.25%) reached approximately $126 million in sales within its first year, with 13,000 doctors prescribing it, highlighting successful disease state awareness for Demodex blepharitis. • Clinical data indicates Miebo provides rapid relief from dry eye symptoms, with patients reporting significant improvement in as little as 3 days, while Xdemvy improves meibomian gland function and reduces related symptoms. • Both medications have secured substantial insurance coverage, with approximately 70% to 80% of insured patients having access, suggesting favorable market access and cost management strategies.

MIEBO Demonstrates Efficacy in Dry Eye Disease Treatment

8 months ago

MIEBO (perfluorohexyloctane ophthalmic solution) is FDA-approved for treating the signs and symptoms of dry eye disease (DED).

Perfluorohexyloctane Shows Promise for Dry Eye Disease in Pooled Phase 3 Analysis

10 months ago

Pooled data from two Phase 3 trials (GOBI and MOJAVE) demonstrate that perfluorohexyloctane ophthalmic solution significantly improves signs and symptoms of dry eye disease (DED).

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access