Perfluorohexyloctane
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed dry eye syndrome 1 milestone | |||||
| Filed | US (FDA) | — | dry eye syndrome | 2022-09-07 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing for investigational treatment NOV03” novaliq.com ↗ “In July 2022 submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) was announced seeking approval for NOV03” novaliq.com ↗ “In September 2022 acceptance of filing of a New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) was announced for NOV03” novaliq.com ↗ “submission of a New Drug Application (NDA) at the end of June to the U.S. Food and Drug Administration (FDA) seeking approval for NOV03” novaliq.com ↗ “In September 2022, Bausch + Lomb and NOV03 announced that the U.S. FDA had accepted the NDA filing for NOV03” novaliq.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | MIEBO | — | 2023-05-18 | fda.gov ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT03333057 | Jan → May 2018 | dry eye syndrome | Novaliq GmbH | Completed | Met primary |
| Phase 34 trials · 2 met primary | ||||||
| Phase 3 | NCT07111013 | Dec 2025 → Apr 2027 | dry eye syndrome | Bausch & Lomb Incorporated | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT04567329 | Nov 2020 → Aug 2021 | dry eye syndrome | Bausch & Lomb Incorporated | Completed | Met primary |
| 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 | Met primary |
| Phase 48 trials · 1 met primary | ||||||
| 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 | Met primary |
| 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 |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT07128628 Comparator | Oct 2025 → May 2026 | dry eye syndrome | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| 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 overdue | dry eye syndrome | Indiana University | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2026-10-02 | Alcon Research | Results SYSTANE PRO Preservative-Free Demonstrates Clinically Comparable Dry Eye Symptom Relief to MIEBO (perfluorohexyloctane ophthalmic solution) in a Prospective, Randomized Clinical Study alcon.com ↗
Between-group difference was -2.7 at 2 weeks and -3.0 at 1 month, p=0.004 and p=0.01 respectively. |
| 2026-08-24 | Bausch Health Americas, Inc. | Results Bausch + Lomb Advancing Two First-in-Class Eye Health Therapies Based on Trial Results bausch.com ↗
Dry Eye Disease Dual-Action Eye Drop: Phase 2 Results Support Advancement to Phase 3 with Day 15 Primary Endpoint |
| 2025-07-08 | Novaliq GmbH | Regulatory Breakthrough in Ophthalmology! Hengrui’s Heng Qin ® (Perfluorohexyloctane Eye Drops) Approved as First Treatment for Dry Eye Disease Associated with MGD novaliq.com ↗
Heng Qin ® is the first and only drug approved to treat DED associated with MGD and will be available to patients in China in the coming months. |
| 2023-05-19 | Novaliq GmbH | Regulatory Bausch + Lomb and Novaliq Announce FDA Approval of MIEBO TM (Perfluorohexyloctane Ophthalmic Solution) for the Treatment of the Signs and Symptoms of Dry Eye Disease novaliq.com ↗
MIEBO is the first and only FDA-approved treatment for DED that directly targets tear evaporation. |
| 2023-03-22 | Novaliq GmbH | Results NOV03 Consistently Met Primary Endpoints for Signs and Symptoms of Dry Eye Disease Associated with Meibomian Gland Dysfunction novaliq.com ↗
today announced that American Journal of Ophthalmology has published results from MOJAVE, the second pivotal Phase 3 trial for NOV03 (perfluorohexyloctane). |
| 2023-02-17 | Novaliq GmbH | Regulatory Jiangsu Hengrui Pharmaceuticals’ Marketing Authorization Application for Innovative Drug SHR8058 (Perfluorohexyloctane) for the Treatment of Dry Eye Disease has been accepted in the People’s Republic of China novaliq.com ↗
The marketing authorization application for SHR8058 (perfluorohexyloctance) eye drops was accepted for the treatment of dry eye disease associated with Meibomian gland dysfunction by NMPA. |
| 2023-01-04 | Novaliq GmbH | Results Bausch + Lomb and Novaliq Announce Publication of Pivotal Phase 3 Data on NOV03 (Perfluorohexyloctane) in Ophthalmology novaliq.com ↗
today announced that Ophthalmology, the peer-reviewed journal of the American Academy of Ophthalmology, has published results from the pivotal Phase 3 trial GOBI, which is one of two pivotal Phase 3 trials for NOV03 (perfluorohexyloctane). |
| 2022-09-07 | Novaliq GmbH | Regulatory FDA accepts NDA filing for NOV03 novaliq.com ↗
the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing for investigational treatment NOV03 (perfluorohexyloctane). |
| 2022-07-07 | Novaliq GmbH | Regulatory Bausch + Lomb and Novaliq Announce Submission of New Drug Application for Investigational Treatment NOV03 (Perfluorohexyloctane) novaliq.com ↗
today announced the submission of a New Drug Application (NDA) at the end of June to the U.S. Food and Drug Administration (FDA) |
| 2022-05-03 | Novaliq GmbH | Results Bausch + Lomb Presents Data from Second Pivotal Phase 3 Trial of Investigational Treatment NOV03 (Perfluorohexyloctane) at the Association for Research in Vision and Ophthalmology Annual Meeting novaliq.com ↗
NOV03 Met Primary Endpoints for Signs and Symptoms of Dry Eye Disease Associated with Meibomian Gland Dysfunction in Both Phase 3 Trials |
| 2022-04-27 | Novaliq GmbH | Results Bausch + Lomb Presents Data from First Pivotal Phase 3 Trial of Investigational Treatment NOV03 at ASCRS Annual Meeting novaliq.com ↗ |
| 2022-04-25 | Novaliq GmbH | Results Bausch + Lomb Presents Data from First Pivotal Phase 3 Trial of Investigational Treatment NOV03 (Perfluorohexyloctane) at the American Society of Cataract and Refractive Surgery Annual Meeting novaliq.com ↗
“The data show that NOV03 met both primary endpoints of total Corneal Fluorescein Staining, a measure that assesses damage to the eye, and visual analogue scale dryness score at day 57,” said Joseph Tauber, M.D., founder of Tauber Eye Center in Kansas City, Mo., and leading NOV03 trial investigator. |
| 2021-12-16 | Novaliq GmbH | Results Phase 3 trial of SHR8058 eye drops (perfluorohexyloctane) conducted by Jiangsu Hengrui Pharmaceuticals in the People’s Republic of China shows statistically significant topline results novaliq.com ↗
The trial met its prespecified primary sign endpoint improvement of total corneal fluorescein staining (tCFS) and its prespecified primary symptom endpoint improvement of eye dryness score of the Visual Analogue Scale (VAS) at eight weeks with high statistical significance. |
| 2021-10-01 | Novaliq GmbH | Results Bausch + Lomb announces statistically significant Topline Results from the Second Phase 3 Trial of NOV03 (perfluorohexyloctane) in Dry Eye Disease associated with Meibomian Gland Dysfunction novaliq.com ↗
These results mark another important milestone in bringing NOV03 to market as a potential first-in-class treatment, and we anticipate filing a New Drug Application to the U.S Food and Drug Administration in 2022. |
| 2021-07-29 | Novaliq GmbH | Results New clinical study shows Novaliq NovaTears ® +Omega-3 eye drops is a significantly effective treatment for dry eye disease novaliq.com ↗
It was developed by Germany’s Novaliq and was shown to deliver clinically relevant and statistically significant improvements in dry eye symptoms in a recent study of 36 patients over eight weeks. |
| 2021-04-13 | Novaliq GmbH | Results Partner Bausch + Lomb Announces Statistically Significant Topline Results from the First Phase 3 Trial of NOV03 novaliq.com ↗
The GOBI trial also met all of its secondary endpoints, showing statistically significant improvements in both the signs and symptoms of DED associated with MGD that were studied. |
| 2018-10-24 | Novaliq GmbH | Results Novaliq announces positive topline results for its SEECASE phase 2 trial of NOV03 for the treatment of patients with dry eye disease novaliq.com ↗ |
| 2018-06-05 | Novaliq GmbH | Results Study finds NovaTears increases tear film, lipid layer thickness. novaliq.com ↗
June 5, 2018 – Gerard Garhöfer, MD, and colleagues reported in a randomized study, that NovaTears has the ability to restore the tear film over time, due to the novel mode of action – perfluorohexyloctane – preventing evaporation by stabilizing the lipid layer. |
| 2018-06-04 | Novaliq GmbH | Results Study finds NovaTears increases tear film, lipid layer thickness novaliq.com ↗
June 4, 2018 – Gerard Garhöfer, MD, and colleagues reported in a randomized study, that NovaTears has the ability to restore the tear film over time, due to the novel mode of action – perfluorohexyloctane – preventing evaporation by stabilizing the lipid layer. |
All press releases naming this drug 26 releases
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 |