Collyres de ciclosporine : étude d’une cohorte de patients de 2009 à 2013

Hornecker, M Kauss; Weber, Sven-Olaf; Piat, M L Brandely; Darrodes, M.; Jomaa, K; Chast, François

doi:10.1016/j.jfo.2015.02.008

Cited by 13 publications

(6 citation statements)

References 34 publications

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“…Close to 6,000 patients were treated in 2013 alone, and they concluded that the prescription of diverse concentrations of CsA eye drops was current practice in both surgical and medical indications, including dry eye patients. Interestingly, the authors also added that Ikervis® registration should have an impact on the use of compounded CsA in DED, which use should henceforth be justified against the labelled alternative, and in which case the prescriber should inform the patient [ 47 ].…”

Section: Discussionmentioning

confidence: 99%

A comparative review of Haute Autorité de Santé and National Institute for Health and Care Excellence health technology assessments of Ikervis® to treat severe keratitis in adult patients with dry eye disease which has not improved despite treatment with tear substitutes

Eroglu

2017

Journal of Market Access & Health Policy

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Background: In 2015, Ikervis® became the only EMA-approved cyclosporine A (CsA) eye-drop for the treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes. Since the 1980s, CsA has been used empirically for ocular conditions in veterinary medicine then in humans. However, its extremely low aqueous solubility led to its administration in vegetable oils, which is characterized by low ocular availability, poor intraocular penetration, poor tolerability and short shelf-life. Concentrations from 0.05% to 2% are compounded on an industrial scale and reimbursed throughout Europe. In France, Ikervis® has been granted an ASMR score of 5 by HAS, whereas in UK NICE endorsed its use. Objective: To review the dry eye disease environment, its challenges and available treatment options, and compare the NICE and HAS assessments to question HAS’ decision to maintain full reimbursement of compounded CsA formulations in the absence of evidence, while reimbursing the EMA-approved drug at 15%. Method: extensive search on PubMED. Results: Comparator selection, composite score assessment and use of CE model are key differentiators. Conclusion: In topical formulations, improvements to the vehicle are key innovations that can bring significant benefits. After the USA, a Compounding Act is needed in Europe.

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Section: Discussionmentioning

confidence: 99%

A comparative review of Haute Autorité de Santé and National Institute for Health and Care Excellence health technology assessments of Ikervis® to treat severe keratitis in adult patients with dry eye disease which has not improved despite treatment with tear substitutes

Eroglu

2017

Journal of Market Access & Health Policy

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“…More specifically, the ophthalmic use (as suspension) of cyclosporine-A includes dry eye syndrome, vernal and atopic keratoconjunctivitis, non-infectious keratitis, Thygeson’s superficial punctate keratitis, ligneous conjunctivitis, lichen planus, superior limbic keratitis, and corneal opacities or subepithelial infiltrates related to keratitis (e.g., viral keratitis) [ 56 ]. There are several studies that justify the use of cyclosporine-A in cases with subepithelial infiltrates attributed to viral keratoconjunctivitis (mostly adenoviruses), especially in patients that require an alternative corticosteroid-sparing treatment or do not respond to other therapeutic modalities [ 57 – 59 ]. According to the current literature, the cyclosporine-A concentrations that have been topically used vary from 0.5–2% [ 60 ].…”

Section: Discussionmentioning

confidence: 99%

“…There are a few side effects reported (i.e., itching, redness, and burning sensation), but the majority of patients do not experience any of them. Overall, patients with keratoconjunctivitis appear to be satisfied as there is an improvement in vision, which is explained by the treatment of subepithelial infiltrates and the lack of recurrences [ 59 , 60 ]. There is supportive evidence that the ophthalmic suspension of cyclosporine-A can restrict the corneal immune reaction in various ocular surface diseases due to its immunomodulatory properties, resulting in enhancement of corneal thickening and epithelial regeneration, and regression of opacification and neovascularization [ 56 , 61 ].…”

Section: Discussionmentioning

confidence: 99%

New Therapeutic Perceptions in a Patient with Complicated Herpes Simplex Virus 1 Keratitis: A Case Report and Review of the Literature

et al. 2017

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Patient: Male, 80Final Diagnosis: Unilateral complicated Herpetic Simplex Virus 1 KeratitisSymptoms: Visual impairmentMedication: Anti-herpetic treatment • Anti-VEGF • Cyclosporine A • Matrix regeneration therapyClinical Procedure: Amniotic membrane and limbal stem cell transplantationSpecialty: OphthalmologyObjective:Management of emergency careBackground:Keratitis caused by herpes simplex virus (HSV) can have detrimental effects on the cornea leading to loss of vision. Modern therapies can contribute to the prevention of anatomical and functional damage.Case Report:An 80-year-old male with complicated HSV-1 keratitis of the left eye (confirmed diagnosis after microbiological investigation) presented three months after antiviral treatment with corneal blurring, severe epitheliopathy, thinning of the stroma, and neovascularization. At the time he was referred, the visual acuity of his left eye was very low, as he could only count fingers at a one-foot distance. He was initially started on oral acyclovir (800 mg once daily) and topical poly-carboxymethyl glucose sulfate; afterwards he underwent amniotic membrane (AM) transplantation and localized treatment with anti-VEGF factors. One month after the AM transplantation there was an obvious improvement of the corneal surface. Ophthalmic suspension of cyclosporine-A 1% was also added to his treatment. After three months, a transplantation of stem cells (deriving from the sclerocorneal junction of his right eye) was carried out at the sclerocorneal junction, as the corneal damage and neovascularization was more severe at this anatomical area. Four months after the last surgery, his visual acuity was 1/10 (note, he had a history of an old vascular episode) and the cornea was sufficiently clear with no signs of epitheliopathy and almost complete subsidence of the neovascularization.Conclusions:Transplantation of AM and stem cells in combination with anti-VEGF factors and topical administration of cyclosporine-A 1% and poly-carboxymethyl glucose sulfate (a regenerative factor of corneal matrix) contributed substantially in the management of herpetic keratitis complications.

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“…The main ocular adverse effects observed are redness, burning sensation and itching. In a study, 64% of the patients treated with cyclosporine were free of the adverse events [31]. In another study, it was observed that even prolonged use of topical cyclosporine for 12 months in patients with dry eye did not cause substantial changes in corneal endothelium [32].…”

Section: Adverse Effectsmentioning

confidence: 97%

Cyclosporine in Dry Eye: A Review

Gupta

2015

Int J Med Res Rev

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Dry eye syndrome (DES) is a multifactorial disease with varying prevalence affecting great chunk of population worldwide. Various environmental, nutritional, hormonal and external factors altering the functional integrity of the ocular surface components have been implicated. The imbalance results in changes in epithelium causing desiccation and setting up an inflammatory cascade which causes dysregulation of the ocular surface regeneration system. With increasing knowledge of the etiology and mechanisms involved in the development of dry eye, role of cyclosporine A has been well established with numerous clinical studies. This has led to the US Food and Drug Administration (FDA) approval of the drug for the treatment of dry eye. This article reviews the pathology of development of dry eye, pharmacology of cyclosporine, use of cyclosporine A in dry eye established via various animal and clinical studies.

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Collyres de ciclosporine : étude d’une cohorte de patients de 2009 à 2013

Cited by 13 publications

References 34 publications

A comparative review of Haute Autorité de Santé and National Institute for Health and Care Excellence health technology assessments of Ikervis® to treat severe keratitis in adult patients with dry eye disease which has not improved despite treatment with tear substitutes

A comparative review of Haute Autorité de Santé and National Institute for Health and Care Excellence health technology assessments of Ikervis® to treat severe keratitis in adult patients with dry eye disease which has not improved despite treatment with tear substitutes

New Therapeutic Perceptions in a Patient with Complicated Herpes Simplex Virus 1 Keratitis: A Case Report and Review of the Literature

Cyclosporine in Dry Eye: A Review

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