November 9, 2017

MC2 Therapeutics A/S announces completion of recruitment in Phase 2 study in moderate-to-severe dry eye disease with MC2-03

  • Completion of patient recruitment meeting randomization target of 264 patients
  • Topline results are expected in 2018

 Copenhagen, November 9th, 2017 – MC2 Therapeutics A/S, a clinical-stage dermatology and eye care company today announced that it has reached its patient recruitment objective for NORTHERN LIGHTS, the company’s Phase 2 trial of MC2-03 PAD ™ Eye Drop (ciclosporin 0.06%) for the treatment of moderate-to-severe dry eye disease. 264 patients with moderate to severe corneal staining and marked dry eye symptoms despite treatment with artificial tears have been recruited.

“We are excited that we have reached this important milestone in our execution of the large high quality clinical trial, which also comprises a comprehensive biomarker study that we hope will bring new and valuable information to the industry” says Jesper J. Lange, President of MC2 Therapeutics.
We hope that the results in the NORTHERN LIGHTS trial will reflect the positive data that we have observed in real-life use in patients in the UK. Using our PAD ™ Technology – a new class of vehicle – we have designed the MC2-03 eye drop with 100% focus on the acute and long-term needs of patients – once daily instillation, high tolerability and effective and safe therapy. We are deeply thankful for the contribution by patients, caretakers and clinicians supporting the recruitment process.” 

About the MC2-03 Phase 2 Trial

The trial is a Phase 2, multicenter, randomized, double-masked, 4 parallel arms, controlled trial designed to evaluate the safety and efficacy of PAD ™ ciclosporin (CsA 0.06% and 0.03%) ophthalmic dispersion administered once daily in combination with lubricant therapy in patients with moderate to severe dry eye disease. The trial has enrolled approximately 264 patients from more than 40 centers across Europe. Patients are followed for 9 months with instillation of trial medication once daily for 6 months and safety follow-up 3 months after completion of treatment. Topline results are expected in 2018.

About Dry Eye

Dry eye is one of the most prevalent ocular diseases affecting 7% to 30% of the population depending on geography. It is often chronic and can worsen with some patients progressing to moderate to severe dry eye. Dry eye, in particular in its moderate to severe form, is a multifactorial disorder caused by inflammation of the ocular surface that results in symptoms of discomfort such as eye dryness, overall eye discomfort, stinging, burning, a gritty feeling or fluctuating blurry vision. Dry eye is most common in women and increases in prevalence with age.

About MC2 Therapeutics A/S

MC2 Therapeutics A/S is a privately held clinical-stage dermatology and eye care company. Using its proprietary PAD ™ Technology – a new class of vehicle – MC2 Therapeutics is developing a pipeline of new highly efficacious topical therapies designed for unique patient experiences.