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Clinical efficacy of MC2‐03 (ciclosporin eye drop) in treatment of dry eye disease patients with severe keratitis randomized in the NORTHERN LIGHTS phase 2b trial
Author(s) -
Praestegaard Morten,
Gomez Frédéric,
Teus Miguel A.,
HorwathWinter Jutta,
Heegaard Steffen
Publication year - 2019
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2019.5296
Subject(s) - medicine , tolerability , randomized controlled trial , clinical trial , ophthalmology , adverse effect
Purpose Anti‐inflammatory treatment of moderate‐to‐severe dry eye disease (DED) remains a challenge with a need for eye drops showing better efficacy and tolerability. The effect of MC2‐03, a novel ciclosporin (CsA) eye drop using PAD™ Technology, was investigated in humans. Methods The NORTHERN LIGHTS trial is a 6 month phase 2b, multicenter, randomized, controlled, double‐masked trial evaluating MC2‐03 (0.03% and 0.06% CsA) administered once daily in 255 patients with moderate‐to‐severe DED with grade 3 and 4 corneal fluorescein staining (CFS) on the modified Oxford scale. The primary objective of the study was to evaluate safety and efficacy of two doses of MC2‐03 compared to vehicle and lubricant comparator. A total of 108 (42.4%) patients with severe keratitis (CFS 4) at Baseline were randomized. Results The proportion of patients with severe keratitis (CFS 4) at Baseline achieving at least 2‐grade improvement in CFS at Month 6 was 63.0% for MC2‐03 0.03%, 41.4% for MC2‐03 0.06% versus 30.8% for both vehicle and lubricant comparator, showing statistical significant improvement for MC2‐03 0.03% compared to vehicle (p = 0.028) and to lubricant (p = 0.028). Further post‐hoc analysis demonstrated that the mean change in CFS from Baseline to Month 6 for MC2‐03 0.03% separated significantly from vehicle (0.8 CFS units, p = 0.012) and lubricant (0.7 CFS units, p = 0.020) with statistical significance already achieved at Month 3. Overall, the trial demonstrated favorable safety of MC2‐03. Conclusion A large unmet need exists for treating moderate‐to‐severe DED patients. The NORTHERN LIGHTS study confirms that MC2‐03 0.03% CsA is effective in treating severe keratitis in this patient group