Bausch + Lomb Corporation announced that Cornea has published results from the KALAHARI phase 3 extension trial, which assessed the long-term safety and efficacy of MIEBO in the treatment of signs and symptoms of dry eye disease (DED). MIEBO became commercially available in September 2023.
"The results from the KALAHARI study reinforce MIEBO as a well-tolerated and effective treatment option to help provide long-term relief for patients with chronic dry eye disease,” said Andrew Stewart, president, Global Pharmaceuticals and International Consumer, Bausch + Lomb.
The phase 3, multicenter, single-arm, open-label extension study evaluated the long-term safety and efficacy of MIEBO in 208 patients 18 years of age and older who had signs and symptoms of DED associated with Meibomian gland dysfunction (MGD), and who completed the randomized, double-masked, hypotonic saline-controlled phase 3 trial (GOBI).
During the trial, participants administered one drop of MIEBO four times daily in both eyes for 52 weeks.
Key points from the trial:
- Patients from GOBI who participated in the KALAHARI study showed sustained efficacy over the entire 52-week study
- MIEBO maintained improvements in total corneal fluorescein staining (tCFS) and visual analog scale (VAS) eye dryness observed in GOBI (mean [SD] change from GOBI study baseline at week 52: -2.1 [2.5] in tCFS score and -33.7 [28.6] in VAS dryness score).
- Patients treated with saline in GOBI who switched to MIEBO treatment in KALAHARI showed improvements in tCFS and VAS scores by week four.
- MIEBO was found to be well-tolerated. There were no serious ocular adverse events (AEs).
- The most common ocular adverse reactions which may have been due to treatment were blurred vision (1.4%), allergic conjunctivitis (1.4%) and increased lacrimation (1.4%).
“With the chronic nature of dry eye disease, tolerability is a critical measure for long-term use and patient adherence,” said Eugene Protzko, MD, lead clinical investigator of the KALAHARI study and ophthalmologist and cataract surgeon, Seidenberg Protzko Eye Associates, Havre de Grace, MD. “A single ingredient, water and preservative-free prescription eye drop, MIEBO was well-tolerated through the duration of KALAHARI, which is consistent with what we observed in the previous shorter-term studies.”
The U.S. Food and Drug Administration (FDA) approved MIEBO in May 2023, based on consistent results from two pivotal phase 3 trials.
Its clinical development program included the first and only phase 3 studies for any FDA-approved prescription DED product composed entirely of patients with both DED and clinical signs of MGD.
MGD is a major cause of DED development and progression, with approximately 86% of people with DED having excessive tear evaporation associated with MGD.1 DED affects more than 38 million Americans and is one of the most common ocular surface disorders.2
References
Lemp, MA, Crews, LA, Bron AJ. (2012). Distribution of Aqueous-Deficient and Evaporative Dry Eye in a Clinic-Based Cohort: a retrospective study. Cornea, 31(5), 472-478. 2012;31(5):472-478. doi:10.109/ICO.0b013e318225415a.
Downs P. 2020 Dry Eye Products Market Report: A Global Analysis for 2019 to 2025. Market Scope; 2020.