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Bausch + Lomb launches MIEBO in the US

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3 min read

Bausch + Lomb Corporation announced that MIEBO (perfluorohexyloctane ophthalmic solution), indicated for the treatment of the signs and symptoms of dry eye disease (DED) is now commercially available in the United States.

Refresh me on the drug’s background.

Novaliq GmbH entered into a strategic cooperation agreement with Bausch + Lomb in 2019 to develop, manufacture, and commercialize MIEBO (originally developed as NOV03) in the U.S. and Canada.

The FDA accepted its new drug application (NDA) filing in September 2022.

Now what is it?

MIEBO is a proprietary, water-free, non-steroidal, single-component, and preservative-free eye drop formulated with 100% perfluorohexyloctane to treat the signs and symptoms of DED in patients ages 18+ years.

How does it work?

The drop spreads rapidly across the ocular surface due to its low surface tension, and interacts with the lipophilic portion of the tear film that prevents tear evaporation.

It also can penetrate the meibomian glands, where it interacts with and dissolves altered, viscous meibum in the glands.

When was it approved?

Back in May 2023. Read our coverage on that here.

And the recommended dosage?

According to the prescribing info, one drop of MIEBO can be administered four times a day into the affected eye(s).

Of note, contact lenses are advised to be removed prior to and for at least 30 minutes after drop administration.

What’s the clinical data on it?

Two multi-center, randomized, double-masked, saline-controlled phase 3 pivotal studies GOBI [NCT04139798] and MOJAVE [NCT04567329]) support the approval.

Both 57-day trials enrolled patients with a history of DED and clinical signs of MGD each met their primary sign and symptom efficacy endpoints:

  • Change from baseline at week 8 (day 57 ± 2) in total corneal fluorescein staining (tCFS)
  • Eye dryness Visual Analog Scale (VAS) score

Additionally, a multi-center, open-label, single-arm, 12-month safety extension trial KALAHARI (NCT04140227) was conducted to assess the long-term data for MIEBO. Per Clinical Trials, no results have been posted as of yet.

Any adverse effects to take note of?

Based on trial data, blurry vision and conjunctival redness were the most common ocular adverse reactions associated with MIEBO used; each occurred in 1% to 3% of patients.

Read more data here.

So where can I find it?

Eyecare professionals can prescribe MIEBO to patients now in their offices. Bausch + Lomb has patient support programs in place with BlinkRx and copay cards.  Click here for more details.

And the significance?

MIEBO is currently the first and only DED treatment approved to directly target tear evaporation.