title: [Cyclosporine eye drops: A 4-year retrospective study (2009-2013)].
abstract: BACKGROUND
  The University Hospitals Paris Centre Pharmacy compounds three concentrations of cyclosporine eye drops: 20mg/mL (=2%); 5mg/mL (=0.5%) and 0.5mg/mL (=0.05%). Cyclosporine A 2% drops were developed in 1995 to prevent the rejection of high-risk cornea transplants after failure of topical steroids. The other concentrations of eye drops were developed for the treatment of various immune or inflammatory diseases of the cornea, conjunctiva and uvea. These eye drops are dispensed with a physician's prescription to hospitalized or ambulatory patients. A retrospective study over 4 years (2009-2013) was conducted to analyze the details of prescription and possible adverse events.
  
  
  METHODS
  Dispensations made from January 1st, 2009 through December 31st, 2013 were studied, including patient age, dose of cyclosporine and practice location of prescribing physician. We also recorded the indications for cyclosporine eye drops in a sample of ambulatory patients. The analysis of local tolerability and the effect on visual comfort was based on questionnaires sent to the patients on cyclosporine 2% over a period of 2 months.
  
  
  RESULTS
  Cyclosporine eye drops prescription grew continuously from 2009 through 2013 for all concentrations. In 2013, 5,859 patients were treated, among which 3,616 patients with topical cyclosporine 2%, 1,681 patients with 0.5%, and 562 patients with 0.05%. In total, this represents 62,621 eye drops. Treated patients ranged from 1 week to 100 years old. Topical 2% cyclosporine is indicated in 61% of cases to prevent high-risk corneal graft rejection. Other indications are corneal ulcer (6%), atopic keratoconjunctivitis (5%), vernal keratoconjunctivitis (5%) and herpetic keratitis (4%). Topical 0.5% cyclosporine is prescribed primarily for dry eye syndrome (20%) and to prevent rejection of high-risk corneal transplantation (11%), to treat ocular rosacea (10%), vernal keratoconjunctivitis (10%), atopic keratoconjunctivitis (8%) and Sjögren's syndrome (7%). Topical 0.05% cyclosporine is prescribed primarily for dry eye syndrome resistant to conventional treatment (47%) and Sjögren's syndrome (21%). Local tolerability of topical cyclosporine was evaluated in 388 patients. The majority of patients (63%) did not experience any adverse effects. The main side effects are redness, burning sensation and itching.
  
  
  CONCLUSIONS
  Prescription of various formulations of topical cyclosporine is current practice for surgical indications: rejection of high-risk corneal transplantation; or medical indications: vernal or atopic keratoconjunctivitis and dry eye syndrome. Further prospective randomized studies would be necessary to validate formulations, doses and indications of cyclosporine eye drops.
authors.affiliation: Service de pharmacie clinique, hôpitaux universitaires Paris Centre, site Hôtel-Dieu, 2, rue d'Arcole, 75004 Paris, France.
authors.forename: M
authors.initials: M
authors.lastname: Kauss Hornecker
authors.affiliation: Service de pharmacie clinique, hôpitaux universitaires Paris Centre, site Hôtel-Dieu, 2, rue d'Arcole, 75004 Paris, France. Electronic address: stephanie.charles-weber@htd.aphp.fr.
authors.forename: S
authors.initials: S
authors.lastname: Charles Weber
authors.affiliation: Service de pharmacie clinique, hôpitaux universitaires Paris Centre, site Hôtel-Dieu, 2, rue d'Arcole, 75004 Paris, France.
authors.forename: M-L
authors.initials: ML
authors.lastname: Brandely Piat
authors.affiliation: Service de pharmacie clinique, hôpitaux universitaires Paris Centre, site Hôtel-Dieu, 2, rue d'Arcole, 75004 Paris, France.
authors.forename: M
authors.initials: M
authors.lastname: Darrodes
authors.affiliation: Service de pharmacie clinique, hôpitaux universitaires Paris Centre, site Hôtel-Dieu, 2, rue d'Arcole, 75004 Paris, France.
authors.forename: K
authors.initials: K
authors.lastname: Jomaa
authors.affiliation: Service de pharmacie clinique, hôpitaux universitaires Paris Centre, site Hôtel-Dieu, 2, rue d'Arcole, 75004 Paris, France.
authors.forename: F
authors.initials: F
authors.lastname: Chast
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D016039:Corneal Transplantation; D016572:Cyclosporine / Q000008:administration & dosage*; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D005128:Eye Diseases / Q000188:drug therapy; D005260:Female; D005602:France; D006084:Graft Rejection / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D012189:Retrospective Studies; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D009883:Ophthalmic Solutions; D016572:Cyclosporine
keywords: Collyre de ciclosporine; Cornea transplantation; Cyclosporine eye drops; Greffe de cornée; Preparation; Préparation hospitalière