Bausch + Lomb Corporation and Novaliq GmbH announced that the FDA has approved MIEBO (perfluorohexyloctane ophthalmic solution) for the treatment of the signs and symptoms of dry eye disease (DED).
Tell me more about MIEBO.
Prior to the commercial approval of MIEBO, the chemical entity under investigation was known as NOV03.
The drug is a proprietary, water-free, non-steroidal, single-component preservative-free eye drop formulated with 100% perfluorohexyloctane to treat DED.
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.
What’s the recommended dosage?
According to the prescribing info, one drop of MIEBO can be administered four times a day into the affected eye(s).
Give me some background on its development.
Novaliq entered into a strategic cooperation agreement with Bausch + Lomb in 2019 to develop, manufacture, and commercialize MIEBO (previously NOV03) in the U.S. and Canada.
The FDA accepted its new drug application (NDA) filing in September 2022.
How about the clinical data?
Two multi-center, randomized, double-masked, saline-controlled phase 3 pivotal studies (GOBI [NCT04139798] and MOJAVE [NCT04567329]) support the approval.
Between both 57-day trials, a total of 1,207 patients with a history of DED and clinical signs of MGD were enrolled.
Tell me more.
Both trials met their primary sign and symptom efficacy endpoints: change from baseline at week 8 (day 57 ± 2) in total corneal fluorescein staining (tCFS) and eye dryness Visual Analog Scale (VAS) score.
How soon did patients experience symptom relief?
As early as day 15 and continuing through day 57.In both studies, a statistically significant reduction was observed in VAS eye dryness score in favor of MIEBO as well as a significant reduction in tCFS at days 15 to 57.
Any other clinical data?
Bausch + Lomb concluded the clinical program for NOV03 with the completion of a multi-center, open-label, single-arm, 12-month safety extension trial referred to as KALAHARI (NCT04140227).
How about adverse effects?
The most common ocular adverse reactions related to MIEBO included blurred vision and conjunctival redness, with each reported between 1-3%.
See here for further data from these trials.
Significance?
This FDA approval is the first—and currently only—for a DED treatment that directly targets tear evaporation.
When will it be available?
Considering this approval is ahead of the original target Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023, it will likely be available in the second half of the year.. stay tuned for further updates!