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Morten Praestegaard, Frederic Gomez, Steffen Klarskov Heegaard, John Kenneth George Dart; Retrospective evaluation of real-life efficacy of PADciclo™ 0.06% ciclosporin in dry eye patients. Invest. Ophthalmol. Vis. Sci. 2017;58(8):2662. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
MC2 Therapeutics is developing PADciclo™, a once daily ocular formulation of ciclosporin designed with penetration and tolerability in mind. PADciclo™ is available in the UK as an unlicensed special, currently in clinical development for the treatment of moderate-severe dry eye. Real-life performance of the unlicensed PADciclo™ 0.06% ciclosporin was evaluated in a retrospective study of dry eye patients at Moorfields Eye Hospital (London) with the purpose of verifying key elements in a prospective clinical trial design.
Dry eye patients included in this analysis (n=22) were required to have i) minimum mild global symptoms and fluorescein staining score of ≥1 on the Oxford scale before initiation of treatment, ii) instilled PADciclo™, iii) reported values of global symptoms and fluorescein staining during treatment. Global symptom severity was graded as absent, mild, moderate or severe (0-3). Ocular surface fluorescein staining was converted to the Oxford scale (0-4). Patient symptoms and signs were included in the analyses where data were available using a pre-defined entry key for data extraction. At the time of analysis 10/22 patients had used PADciclo™ for more than 26 weeks, with a duration ranging from 4-52 weeks for the whole group.
The global symptom score improved in 13/22 patients with a mean change of 0.7 [p<0.01]. 9/13 patients with initial moderate symptoms and 4/8 patients with mild symptoms improved during treatment. The Oxford scale score reduced in 16/22 patients with a mean change of 0.8 [p<0.001], which generally occurred within 3 months of treatment. A trend was observed that 2/22 patients with initial Oxford score ≥3 responded better than 7/22 and 13/22 patients with initial score 1 or 2, respectively. 1/22 patients discontinued treatment because of poor tolerance. None discontinued because of lack of efficacy and overall safety was confirmed.
The data indicates that PADciclo™ 0.06% is effective in reducing corneal staining and global symptoms of dry eye. The response to treatment increases with severity at baseline for global symptoms and corneal staining. Discontinuation because of intolerance to ciclosporin or the formulation vehicle is well-known for Ikervis® and Restasis®. Only one patient (4.5%) discontinued PADciclo™ treatment in this cohort. These results have guided the design of the ongoing clinical development of PADciclo™.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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