FDA Approves Perfluorohexyloctane Ophthalmic Solution for Dry Eye Disease

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Announced by Bausch + Lomb and Novaliq, the prescription eye drop for DED is the first and only drop that directly targets tear evaporation, with approval based on results from 2 pivotal phase 3 trials.

US Food and Drug Administration (FDA) logo

US Food and Drug Administration (FDA)

The US Food and Drug Administration (FDA) has approved perfluorohexyloctane ophthalmic solution (MIEBO™), formerly known as NOV03, for the treatment of the signs and symptoms of dry eye disease (DED).1

The ophthalmic solution is the first-and-only prescription drop approved for DED that directly targets tear evaporation, according to a press release from Bausch + Lomb and Novaliq.

“Tear evaporation, which is a leading driver of DED, presents a significant treatment challenge,” Paul Karpecki, OD, director of cornea and external disease at Kentucky Eye Institute said in a statement.1 “With the approval of MIEBO, eye care professionals can now take a new approach to DED therapy with a first-in-class water- and preservative-free prescription treatment option that specifically addresses tear evaporation.”

Millions of people in the United States are affected by DED, making it one of the most common ocular surface disorders.2 Excessive tear evaporation is a leading cause of DED and due to an altered tear lipid layer, is often associated with the clinical signs of Meibomian gland dysfunction (MGD). An estimated 86% of people with DED have excessive tear evaporation in which MGD is a major contributor.

As an unstable tear film triggers increased ocular surface, desiccation, inflammation, and damage to the ocular surface, perfluorohexyloctane ophthalmic solution is designed to reduce tear evaporation at the ocular surface. The FDA approval was based on consistent results from 2 consecutive pivotal phase 3 trials, the GOBI and MOJAVE trials. More than 1,200 patients with a history of DED and clinical signs of MGD were enrolled and randomized 1:1 to perfluorohexyloctane ophthalmic solution or hypotonic saline.

The 2 primary endpoints were the change from baseline at week 8 (day 57 ± 2) in total corneal fluorescein staining (tCFS) and eye dryness Visual Analog Scale (VAS) score. Results from the 2 trials revealed perfluorohexyloctane ophthalmic solution consistently met its primary clinical sign and patient-reported symptom endpoint.

Patients with DED were reported to have experienced relief of symptoms as early as day 15 and through day 57 with statistically significant reduction in VAS eye dryness score favoring perfluorohexyloctane ophthalmic solution in both studies. Moreover, at day 15 and day 57, both studies showed a significant reduction in tCFS favoring perfluorohexyloctane ophthalmic solution.3 Regarding safety, the most common adverse reactions experienced with perfluorohexyloctane ophthalmic solution were blurred vision (1.3 - 3%) and eye redness (1 - 3%).

“In the two pivotal clinical trials, MIEBO addressed the persistent and chronic nature of DED by providing sustained improvement in both the signs and symptoms of DED,” Preeya Gupta, MD, cornea and cataract surgeon at Triangle Eye Consultants said in a statement. “Because MIEBO inhibits evaporation, it may be an appropriate treatment option for patients whose tear evaporation exceeds tear supply.”

The company expects to make perfluorohexyloctane ophthalmic solution commercially available in the second half of 2023.

“Today’s FDA approval of MIEBO further advances DED treatment by addressing a significant unmet need for millions of people suffering with this disease,” Brent Saunders, chairman and CEO, Bausch + Lomb, said in a statement. “We are proud to bring to market the first and only prescription eye drop approved in the United States for the treatment of DED that directly targets evaporation.”

References

  1. Bausch + Lomb and Novaliq announce FDA approval of MieboTM (Perfluorohexyloctane Ophthalmic Solution) for the treatment of the signs and symptoms of dry eye disease. Business Wire. May 18, 2023. Accessed May 19, 2023. https://www.businesswire.com/news/home/20230518005700/en/Bausch-Lomb-and-Novaliq-Announce-FDA-Approval-of-MIEBO%E2%84%A2-Perfluorohexyloctane-Ophthalmic-Solution-for-the-Treatment-of-the-Signs-and-Symptoms-of-Dry-Eye-Disease.
  2. National Eye Institute. Dry Eye. Last updated April 8, 2022. Accessed May 19, 2023. https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/dry-eye
  3. Iapoce C. Phase 3 mojave trial reports efficacy of nov03 for dry eye disease. HCP Live. March 24, 2023. Accessed May 19, 2023. https://www.hcplive.com/view/phase-3-mojave-trial-reports-efficacy-of-nov03-for-dry-eye-disease.
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