Bausch + Lomb Corporation announced the publication of new data in Cornea from the KALAHARI phase 3 extension trial examining the long-term safety and efficiency of MIEBO for dry eye disease (DED).
Quick refresher on MIEBO, please.
FDA approved in May 2023 and commercially launched in the United States in September 2023, MIEBO is the first (and currently only) prescription eye drop formulated to directly target tear evaporation in DED.
The proprietary, water-free, non-steroidal, single-component, and preservative-free eye drop—formulated with 100% perfluorohexyloctane—is intended to be administered four times a day into the affected eye(s). See its prescribing info here.
And the clinical data on it so far?
Two multi-center, randomized, double-masked, saline-controlled phase 3 pivotal studies GOBI (NCT04139798) and MOJAVE (NCT04567329) supported the drop’s 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)
- Dryness Score rated on a Visual Analog Scale (VAS)
So what’s this KALAHARI study?
The multi-center, open-label, single-arm, 12-month safety extension trial (NCT04140227) tracked the long-term use of MIEBO administered as prescribed in 208 patients (ages 18+) with DED associated with meibomian gland dysfunction (MGD) for 52 weeks.
To note, all participants had previously completed the phase 3 GOBI trial, where they had received either MIEBO (n = 97) or saline (n = 111).
What was measured?
Safety assessments included:
- Adverse events
- Best-corrected visual acuity (BCVA)
- Slit-lamp biomicroscopy
- Intraocular pressure (IOP)
- Dilated fundoscopy
And efficacy endpoints were:
- Change from GOBI study baseline in total corneal fluorescein staining (tCFS)
- Dryness Score (0 - 100 visual analog scale [VAS])
Now the findings.
Overall, participants showed sustained efficacy throughout the study duration, with MIEBO continuing to improve tCFS and Dryness Score previously seen in GOBI (from baseline to week 52):
- tCFS = -2.1. (mean change = 2.5)
- Dryness Score = -33.7 (mean change = 28.6)
Was this also the case for patients previously treated with saline?
Yes. Those 111 patients treated with saline during the GOBI study were switched over to MIEBO for the 52-week study duration.
Improvements in both tCFS and Dryness Score were noted at week 4 and maintained throughout the study period.
Any adverse effects?
While MIEBO was well-tolerated and had no serious ocular adverse events (AEs) associated with it, the 13.9% (29) of participants developed ≥1 mild or moderate ocular adverse event. The most common included:
- Allergic conjunctivitis (1.4%)
- Blurred vision (1.4%)
- Increased lacrimation (1.4%)
And the significance of these results?
Given the chronic nature of DED, according to Eugene E. Protzko, MD, lead clinical investigator of the study, “tolerability is a critical measure for long-term use and patient adherence.”
Dr. Protzko added that the finding of MIEBO being well-tolerated throughout the study duration “is consistent with what we observed in the previous shorter-term studies.”