July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
MC2-03, an innovative ciclosporin eyedrop, shows favorable safety and tolerability after 6 months of treatment in moderate-to-severe DED patients
Author Affiliations & Notes
  • Morten Prastegaard
    MC2 Therapeutics, Hoersholm, Denmark
  • Frederic Gomez
    MC2 Therapeutics, Hoersholm, Denmark
  • Johan Selmer
    MC2 Therapeutics, Hoersholm, Denmark
  • Steffen Heegaard
    Rigshospitalet, Copenhagen, Denmark
  • Footnotes
    Commercial Relationships   Morten Prastegaard, MC2 Therapeutics (E); Frederic Gomez, MC2 Therapeutics (E); Johan Selmer, MC2 Therapeutics (E); Steffen Heegaard, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 6744. doi:
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      Morten Prastegaard, Frederic Gomez, Johan Selmer, Steffen Heegaard; MC2-03, an innovative ciclosporin eyedrop, shows favorable safety and tolerability after 6 months of treatment in moderate-to-severe DED patients. Invest. Ophthalmol. Vis. Sci. 2019;60(9):6744.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose : The NORTHERN LIGHTS study is a randomized, double masked, controlled multicentre European study that assessed MC2-03 (ciclosporin 0.03% and 0.06%) for the treatment of moderate-to-severe dry eye disease. The objective of the study was to evaluate safety and efficacy of MC2-03 after treatment for 6 months and a 3 month safety follow-up.

Methods : 263 patients were randomised to four treatment groups in a 1:1:1:1 ratio. During the 6 months double masked period, patients were to be enrolled and randomized to receive one drop of either: MC2-03 0.03% w/w, MC2-03 0.06% w/w, MC2-03 vehicle or 0.3% w/w hypromellose lubricant once daily (QD) in each eye at bedtime. All patients were further treated with hypromellose lubricant during the day. The subsequent 3 month extension follow-up period was designed to generate safety data over the whole duration of the 9-month study. The study population involved patients from 10 different countries in Europe.

Results : During 6 months of treatment, the majority of the treatment emergent adverse events (TEAEs) related to the study medication observed in all arms were ocular in nature and significantly more common in the ciclosporin arms compared to the vehicle and lubricant arms. No serious adverse events were related to MC2-03 treatment. The most frequent TEAEs were related to the instillation of the eye drops, i.e. instillation site pain (15.7% and 16.4% for MC2-03 0.06% and 0.03%, respectively) and instillation site discomfort (4.3% and 1.5% for MC2-03 0.06% and 0.03%, respectively). Ocular hyperemia was low (2.9% and 1.5% for MC2-03% 0.06 and 0.03%, respectively) compared to an existing formulation of ciclosporin available in Europe (5.5%). No cases of loss of visual acuity was reported. There was no evidence of a sustained rise in IOP above normal physiological limits in neither the ciclosporin arms nor the vehicle and lubricant groups.

Conclusions : The present results confirm favourable tolerability and safety of the MC2-03 eye drop.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.


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