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Perfluorohexyloctane Ophthalmic Solution: A Review in Dry Eye Disease

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Abstract

Perfluorohexyloctane ophthalmic solution (Miebo®) is a single-entity, water-, steroid- and preservative-free, first-in-class semifluorinated alkane that is approved in the USA for the treatment of the signs and symptoms of dry eye disease (DED). DED is often linked with meibomian gland dysfunction (MGD), which causes an excessive evaporation of tears. Perfluorohexyloctane ophthalmic solution stabilizes the lipid layer of the tear film and inhibits tear evaporation by forming a monolayer at the air-liquid interface. In the phase III GOBI and MOJAVE trials in adults with DED associated with MGD, one drop of perfluorohexyloctane ophthalmic solution instilled in each eye four times daily over 8 weeks resulted in statistically significant and clinically meaningful improvements in the signs and symptoms of DED compared with hypotonic saline (0.6%). The agent was generally well tolerated, with most ocular adverse events being mild or moderate in severity. The efficacy and tolerability of perfluorohexyloctane ophthalmic solution was sustained for up to 52 weeks in an extension study (KALAHARI). As the first and currently the only prescription treatment approved in the USA directly addressing the pathophysiology of excessive tear evaporation, perfluorohexyloctane ophthalmic solution is a valuable emerging option for the management of DED.

Plain Language Summary

Dry eye disease (DED) is a common eye disorder caused by many factors. In most cases, DED is linked with meibomian gland dysfunction (MGD), which causes an excessive evaporation of tears. Perfluorohexyloctane ophthalmic solution (Miebo®), a single-entity, water-, steroid- and preservative-free, first-in-class semifluorinated alkane, is approved in the USA for the treatment of the signs and symptoms of DED. The agent stabilizes the lipid layer of the tear film and prevents the evaporation of tears by forming a layer on the surface of the tear film. In two phase III clinical trials in adults with MGD-associated DED, one drop of perfluorohexyloctane ophthalmic solution instilled in each eye four times daily over 8 weeks led to significant improvements in the signs and symptoms of DED when compared with hypotonic saline (0.6%). Perfluorohexyloctane ophthalmic solution was generally well tolerated, with most ocular adverse events being mild or moderate in severity. Thus, as the first and currently the only prescription treatment approved in the USA directly addressing excessive tear evaporation, perfluorohexyloctane ophthalmic solution is a valuable emerging option for the management of DED.

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References

  1. Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II definition and classification report. Ocul Surf. 2017;15(3):276–83.

    Article  PubMed  Google Scholar 

  2. Jones L, Downie LE, Korb D, et al. TFOS DEWS II management and therapy report. Ocul Surf. 2017;15(3):575–628.

    Article  PubMed  Google Scholar 

  3. Sheppard JD, Nichols KK. Dry eye disease associated with meibomian gland dysfunction: focus on tear film characteristics and the therapeutic landscape. Ophthalmol Ther. 2023;12(3):1397–418.

    Article  PubMed  PubMed Central  Google Scholar 

  4. Stapleton F, Alves M, Bunya VY, et al. TFOS DEWS II epidemiology report. Ocul Surf. 2017;15(3):334–65.

    Article  PubMed  Google Scholar 

  5. Wrobel-Dudzinska D, Osial N, Stepien PW, et al. Prevalence of dry eye symptoms and associated risk factors among university students in Poland. Int J Environ Res Public Health. 2023;20(2):1313.

    Article  PubMed  PubMed Central  Google Scholar 

  6. Barabino S, Benitez-Del-Castillo JM, Fuchsluger T, et al. Dry eye disease treatment: the role of tear substitutes, their future, and an updated classification. Eur Rev Med Pharmacol Sci. 2020;24(17):8642–52.

    CAS  PubMed  Google Scholar 

  7. Sabeti S, Kheirkhah A, Yin J, et al. Management of meibomian gland dysfunction: a review. Surv Ophthalmol. 2020;65(2):205–17.

    Article  PubMed  Google Scholar 

  8. Mukamal R. Improved dry eye drugs for 2022 and beyond. 2021. https://www.aao.org/eye-health/tips-prevention/new-dry-eye-treatments-ocular-surface-disease. Accessed 27 Feb 2024.

  9. US Food and Drug Administration. MIEBO (perfluorohexyloctane ophthalmic solution) for topical ophthalmic use: US prescribing information. 2024. https://dailymed.nlm.nih.gov/dailymed. Accessed 27 Feb 2024.

  10. Agarwal P, Scherer D, Günther B, et al. Semifluorinated alkane based systems for enhanced corneal penetration of poorly soluble drugs. Int J Pharm. 2018;538(1–2):119–29.

    Article  CAS  PubMed  Google Scholar 

  11. Tsagogiorgas C, Otto M. Semifluorinated alkanes as new drug carriers-an overview of potential medical and clinical applications. Pharmaceutics. 2023;15(4):1211.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  12. Tauber J, Wirta DL, Sall K, et al. A randomized clinical study (SEECASE) to assess efficacy, safety, and tolerability of NOV03 for treatment of dry eye disease. Cornea. 2021;40(9):1132–40.

    Article  PubMed  Google Scholar 

  13. Liu X, Riess J, Krafft M. Self-organization of semifluorinated alkanes and related compounds at interfaces: thin films, surface domains and two-dimensional spherulites. Bull Chem Soc Jpn. 2018;91(5):846–57.

    Article  CAS  Google Scholar 

  14. Krösser S, Spencer E, Grillenberger R, et al. Ocular and systemic distribution of 14C- perfluorohexyloctane following topical ocular administration to rabbits [abstract no. 2656 plus poster]. Invest Ophthalmol Vis Sci. 2018;59(9):2656.

  15. Schmidl D, Bata AM, Szegedi S, et al. Influence of perfluorohexyloctane eye drops on tear film thickness in patients with mild to moderate dry eye disease: a randomized controlled clinical trial. J Ocul Pharmacol Ther. 2020;36(3):154–61.

    Article  CAS  PubMed  Google Scholar 

  16. Steven P, Augustin AJ, Geerling G, et al. Semifluorinated alkane eye drops for treatment of dry eye disease due to meibomian gland disease. J Ocul Pharmacol Ther. 2017;33(9):678–85.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  17. Borchman D, Vittitow J, Kissling R, et al. Spectroscopic characterization of perfluorohexyloctane, an eye drop for dry eye disease [abstract no. 3975-B0292 plus poster]. Invest Ophthalmol Vis Sci. 2023;64(8):3975.

  18. Stolowich N, Vittitow J, Kissling R, et al. Oxygen-carrying capacity of perfluorohexyloctane, a novel eye drop for dry eye disease. Curr Ther Res Clin Exp. 2023;98(100705):1–5.

    Google Scholar 

  19. Agarwal P, Khun D, Krösser S, et al. Preclinical studies evaluating the effect of semifluorinated alkanes on ocular surface and tear fluid dynamics. Ocul Surf. 2019;17(2):241–9.

    Article  PubMed  Google Scholar 

  20. Steven P, Scherer D, Krösser S, et al. Semifluorinated alkane eye drops for treatment of dry eye disease-a prospective, multicenter noninterventional study. J Ocul Pharmacol Ther. 2015;31(8):498–503.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  21. Vittitow J, Kissling R, DeCory H, et al. In vitro inhibition of evaporation with perfluorohexyloctane, an eye drop for dry eye disease. Curr Ther Res Clin Exp. 2023;98(100704):1–7.

    Google Scholar 

  22. Delicado-Miralles M, Velasco E, Díaz-Tahoces A, et al. Deciphering the action of perfluorohexyloctane eye drops to reduce ocular discomfort and pain. Front Med (Lausanne). 2021. https://doi.org/10.3389/fmed.2021.709712.

    Article  PubMed  PubMed Central  Google Scholar 

  23. Borchman D, Cavet M, DeCory H, et al. Visualization of perfluorohexyloctane, an eye drop for dry eye disease, on the human ocular surface using infrared emissivity [poster]. Annual meeting of the American Academy of Ophthalmology. 2023.

  24. Tauber J, Berdy GJ, Wirta DL, et al. NOV03 for dry eye disease associated with meibomian gland dysfunction: results of the randomized phase 3 GOBI study. Ophthalmology. 2023;130(5):516–24.

    Article  PubMed  Google Scholar 

  25. Sheppard JD, Kurata F, Epitropoulos AT, et al. NOV03 for signs and symptoms of dry eye disease associated with meibomian gland dysfunction: the randomized phase 3 MOJAVE study. Am J Ophthalmol. 2023;252:265–74.

    Article  CAS  PubMed  Google Scholar 

  26. Protzko EE, Segal BA, Korenfeld MS, et al. Long-term safety and efficacy of perfluorohexyloctane ophthalmic solution for the treatment of patients with dry eye disease: the KALAHARI Study. Cornea. 2023. https://doi.org/10.1097/ICO.0000000000003418.

  27. Fahmy A, Evans D, Harthan J, et al. Perfluorohexyloctane (NOV03) for dry eye disease associated with meibomian gland dysfunction: pooled analysis of GOBI and MOJAVE studies [poster]. Annual Meeting of the American Optometric Association. 2023.

  28. Groß D, Kaercher T. Comparison of the clinical efficacy of three different eye drops for the treatment of dry eye. EC Ophthalmol. 2021;12(6):32–44.

    Google Scholar 

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Acknowledgments

During the peer review process the manufacturer of perfluorohexyloctane ophthalmic solution was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Amy Zhuang-Yan & Yahiya Y. Syed

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  1. Amy Zhuang-Yan
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Correspondence to Amy Zhuang-Yan.

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The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest

Amy Zhuang-Yan and Yahiya Y. Syed are salaried employees of Adis International Ltd/Springer Nature, and declare no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.

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Additional information

The manuscript was reviewed by: E. Anastasopoulos, 2nd Department of Ophthalmology, Aristotle University of Thessaloniki, Thessaloniki, Greece; F. Hakim, Department of Ophthalmology, University of Michigan, Ann Arbor, MI, USA; J. Luchs, Florida Vision Institute, West Palm Beach, FL, USA.

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Zhuang-Yan, A., Syed, Y.Y. Perfluorohexyloctane Ophthalmic Solution: A Review in Dry Eye Disease. Drugs (2024). https://doi.org/10.1007/s40265-024-02016-5

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