Perfluorohexyloctane
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | MIEBO | — | 2023-05-18 | fda.gov ↗ |
Trials 13 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT03333057 | Jan → May 2018 | dry eye syndrome | Novaliq GmbH | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT07111013 | Dec 2025 → Apr 2027 | dry eye syndrome | Bausch & Lomb Incorporated | Withdrawn | No outcome recorded |
| Phase 3 | NCT04567329 | Nov 2020 → Aug 2021 | dry eye syndrome | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT04140227 | Sep 2020 → Jan 2022 | dry eye syndrome | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT04139798 | Jul 2020 → Mar 2021 | dry eye syndrome | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT07679685 | Jun 2026 → Feb 2027 expected | dry eye syndrome | Beijing Tongren Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07054606 | Jul → Nov 2025 | dry eye syndrome | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 4 | NCT06565650 | Jul 2024 → Nov 2025 overdue | dry eye syndrome | Bausch & Lomb Incorporated | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06671041 | May → Aug 2024 | dry eye syndrome | Southern College of Optometry | Completed | No outcome recorded |
| Phase 4 | NCT06346340 | Apr 2024 → Feb 2025 | dry eye syndrome | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 4 | NCT06309953 | Feb → Jun 2024 | dry eye syndrome | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 4 | NCT06176651 | Sep 2023 → Apr 2024 | dry eye syndrome | Gordon Schanzlin New Vision | Completed | No outcome recorded |
| Phase 4 | NCT05723770 | Aug → Dec 2023 | dry eye syndrome | Bausch & Lomb Incorporated | Completed | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT07128628 Comparator | Oct 2025 → May 2026 | dry eye syndrome | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07650708 Comparator | May → Nov 2026 expected | dry eye syndrome | Vance Thompson Vision | Recruiting | No outcome recorded |
| Phase 4 | NCT07243275 Comparator | Feb → Sep 2026 expected | dry eye syndrome | Indiana University | Recruiting | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Perfluorohexyloctane | “The objectives of this trial are to evaluate the safety and tolerability of perfluorohexyloctane (NOV03) ophthalmic solution during long-term use in subjects with Dry Eye...” NCT04140227 ↗14“PURPOSE: To evaluate the efficacy and safety of NOV03 (perfluorohexyloctane) ophthalmic drop for the treatment of signs and symptoms of dry eye disease (DED) associated with...” PMID 36948372 ↗ Mar 2023 “Perfluorohexyloctane ophthalmic solution (PFHO) forms a protective layer on the tear film surface to reduce evaporation and is approved for treatment of signs and symptoms of DED.” PMID 41588216 ↗ Jan 2026 “This study evaluated treatment effects of perfluorohexyloctane ophthalmic drop (formerly NOV03) in the pooled dataset from 2 pivotal clinical trials” PMID 39564145 ↗ Nov 2024 “Miebo (Perfluorohexyloctane) is a novel, non-aqueous, single entity, preservative free, ophthalmic drop.” NCT06176651 ↗ “Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)” NCT03333057 ↗ “Perfluorohexyloctane (PFHO) ophthalmic solution (MIEBO™; Bausch + Lomb)” NCT06671041 ↗ “Miebo® (perfluorohexyloctane ophthalmic solution)” NCT06309953 ↗ “100% perfluorohexyloctane” NCT06565650 ↗ “Perfluorohexyloctane” NCT05723770 ↗ |
| Known as | Hengqin | “perfluorohexyloctane (PFHO) eye drops (Hengqin®, Chengdu Shengdi Pharmaceutical Co., Ltd.)” NCT07679685 ↗ |
| Known as | MIEBO | “Perfluorohexyloctane (PFHO) ophthalmic solution, which is marketed in the United States as MIEBO™ (Bausch + Lomb; Rochester, NY, USA) is a preservative-free eye drop.” NCT07243275 ↗6“Patients instilled 1 drop of PFHO (MIEBO, Bausch + Lomb) 4 times daily in both eyes for 52 weeks.” PMID 37921522 ↗ Nov 2023 “Perfluorohexyloctane (PFHO) ophthalmic solution (MIEBO™; Bausch + Lomb)” NCT06671041 ↗ “Miebo® (perfluorohexyloctane ophthalmic solution)” NCT06309953 ↗ “Miebo (perfluorohexyloctane ophthalmic solution)” NCT07054606 ↗ |
| Known as | NOV03 | “The aim of this study was to assess the long-term safety and efficacy of perfluorohexyloctane (PFHO) ophthalmic drop (formerly NOV03) for treatment of dry eye disease (DED).” PMID 37921522 ↗ Nov 20233“This study evaluated treatment effects of perfluorohexyloctane ophthalmic drop (formerly NOV03) in the pooled dataset from 2 pivotal clinical trials” PMID 39564145 ↗ Nov 2024 |
| Known as | PFHO | “Perfluorohexyloctane ophthalmic solution (PFHO) forms a protective layer on the tear film surface to reduce evaporation and is approved for treatment of signs and symptoms of DED.” PMID 41588216 ↗ Jan 20265“The aim of this study was to assess the long-term safety and efficacy of perfluorohexyloctane (PFHO) ophthalmic drop (formerly NOV03) for treatment of dry eye disease (DED).” PMID 37921522 ↗ Nov 2023 “Perfluorohexyloctane (PFHO) ophthalmic solution, which is marketed in the United States as MIEBO™ (Bausch + Lomb; Rochester, NY, USA) is a preservative-free eye drop.” NCT07243275 ↗ “Perfluorohexyloctane ophthalmic solution (PFHO) is indicated for the treatment of signs and symptoms of dry eye disease (DED) and targets excessive tear evaporation.” PMID 39985746 ↗ Feb 2025 “perfluorohexyloctane (PFHO) eye drops (Hengqin®, Chengdu Shengdi Pharmaceutical Co., Ltd.)” NCT07679685 ↗ “Perfluorohexyloctane (PFHO) ophthalmic solution (MIEBO™; Bausch + Lomb)” NCT06671041 ↗ |
| Route | Topical | “ophthalmic drop” PMID 37921522 ↗ Nov 2023 |