Abstract
Purpose :
The NORTHERN LIGHTS phase 2 trial assessed MC2-03 (ciclosporin (CsA) 0.03% and 0.06%) for the treatment of patients with moderate to severe dry eye disease. The objective of the trial was to evaluate safety and efficacy of MC2-03 eye drops after treatment for 6 months. Here we present data on the efficacy of MC2-03 eye drops on HLA-DR expression in conjunctival cells and its correlation to corneal staining severity.
Methods :
The trial was an approved, randomized, double masked, multicenter trial of 263 patients with moderate to severe dry eye recruited from 10 different countries in Europe. The patients were randomized equally to receive one drop of either MC2-03 0.03% CsA, MC2-03 0.06% CsA, MC2-03 vehicle or 0.3% w/w hypromellose lubricant once daily (QD) in each eye at bedtime for 6 months. All patients were also treated with hypromellose lubricant during the day. HLA-DR expression was evaluated in conjunctival cells sampled from 192 patients by impression cytology using the EyePrim™ device at Baseline and at Month 6 (end-of-treatment).
Results :
A mean of ~18,700 cells per sample was collected. The overall HLA-DR expression was detected in a mean of 3.4% of cells at Baseline and 2.8% of cells at Month 6. The HLA-DR expression reduced significantly in patients treated with MC2-03 eye drops as compared to vehicle (p<0.05). Generally, patients with Sjögren syndrome had a higher Baseline HLA-DR expression (4.4% of cells, n=45) as well as a more robust reduction of HLA-DR expression when treated with MC2-03 eye drops (p<0.05). HLA-DR expression in individual patients correlated with their corneal staining severity at Baseline (p<0.01). The change in HLA-DR expression from Baseline to Month 6 correlated to the proportion of MC2-03 treated patients obtaining clear to mild corneal staining at Month 6 (p<0.05).
Conclusions :
Changes in HLA-DR expression in conjunctival cells and its appropriate correlation with corneal staining severity strongly support the treatment efficacy of MC2-03 ciclosporin eye drops for patients with moderate to severe dry eye, particularly Sjögren syndrome patients.
This is a 2020 ARVO Annual Meeting abstract.