Recent study results have provided real-world evidence supporting the effectiveness, tolerability, and safety profile of Ikervis, a 0.1% ciclosporin eye drop, in the management of severe keratitis in dry eye disease.
The PERSPECTIVE study results, published in Ophthalmology and therapy, demonstrated significant improvement in corneal fluorescein staining (CFS) score from baseline at month 12, following Ikervis initiation in patients living with severe keratitis in dry eye disease (DED) who remained insufficiently controlled despite treatment with artificial tears.
The prospective, multicentre, observational study has expanded the real-world evidence base for the use of ciclosporin 0.1% cationic emulsion (CE) in managing severe keratitis in adults living with dry eye disease (DED) insufficiently controlled by artificial tears (ATs).1
Conducted at 44 ophthalmology clinics throughout Northern Europe*, the study recruited 472 people based on a diagnosis of DED and severe keratitis, who were considered by their treating physician to have shown insufficient improvement with their current AT treatment.1
The study examined real-world clinical practice and patient-reported outcomes on the effectiveness, tolerability and safety of using Ikervis once-daily.1
According to ophthalmic surgeon, and head of the Corneal Unit at Sydney Eye Hospital, Professor Stephanie Watson, studies examining how dry eye disease can be effectively managed, and treatment options that can help address symptoms while remaining well tolerated, are invaluable for patients’ long-term eye health.
“PERSPECTIVE provides real-world evidence and insights into the clinical applicability of Ikervis, and how it can potentially make a real difference to patients’ vision and symptom management,”1 she said.
“The positive patient-reported outcomes should contribute to increasing prescriber confidence in the use of Ikervis to treat severe keratitis in dry eye disease.”
The study
PERSPECTIVE identified significant improvements in mean CFS score from baseline over the 12-month treatment period (mean change, -1.42; p<0.0001), with incremental reductions observed from week four.1
Overall, 77.5% demonstrated a reduction in CFS score from baseline.1 Severity of eyelid erythema significantly decreased from baseline at week four through to month 12 – moderate- to-severe erythema was reported in 30.8% of patients at baseline compared to 9.2% at month 12 (p<0.001).1
There was also a statistically significant reduction in conjunctival erythema from baseline at week four, maintained through month 12, with moderate-to-severe conjunctival erythema observed in 28.3% of patients at baseline and 9% at month 12 (p<0.001).1
Both tear film breakup time and ocular symptom severity demonstrated significant improvements at all study visits through month 12 (p<0.001).1 Furthermore, of the 280 adverse events (AEs) reported during the study period, 101 were considered treatment-related, with the majority of the AEs (88.6%) non-serious in nature.1 By the end of the study, most treatment-related AEs (73.3% had resolved, or were resolving.1
Patient evaluation of tolerability revealed a high level of satisfaction throughout the 12-month treatment period.1 Overall, 77% of patients reported tolerability with Ikervis to be good, or very good at month 12.1
Ocular symptoms assessed during the study comprised foreign body sensation, burning/stinging, itching, pain, blurred vision, sticky feeling and photophobia.1 Symptom severity was recorded using a 4-point scale (none, mild, moderate, and severe).1 Each of the examined symptoms were significantly improved from week four following initiation of Ikervis, and at all subsequent study visits (p<0.001),1 reflecting other recent, real- world data on the use of Ikervis in severe keratitis in DED.2
“While randomised controlled trials are usually considered more reliable, real-world evidence reflects key aspects of clinical practice.** The real-world data collected in PERSPECTIVE is of practical benefit, and may help inform the use of Ikervis in a real-world setting,” Watson said.
“The positive patient feedback is encouraging and supports the outcomes achieved with Ikervis. The majority of those living with severe keratitis in dry eye disease reported significant improvements in their condition, and generally felt better without experiencing any major side-effects.1
“Collectively, these findings should provide prescribers and patients alike with confidence in the clinical applicability of Ikervis in the management of severe keratitis from DED.”
How Ikervis works
Watson said artificial tears generally only provide short-term relief and lubrication at the eye surface, which may not be sufficiently effective for cases of severe keratitis associated with DED.1,5
“Subsequently, in cases of severe keratitis from DED, there is a significant, unmet clinical need for a treatment option which addresses the underlying pathophysiology of DED, offering long-lasting, reliable disease control.1” she said.
Ikervis harnesses cationic nanoemulsion technology to deliver ciclosporin, a calcineurin inhibitor immunosuppressant agent, to the eye surface, which works to reduce dry eye signs and symptoms by inhibiting the production and/or release of pro-inflammatory cytokines.6,9
The efficacy and safety of Ikervis were evaluated in two pivotal, Phase 3, randomised, double-masked, vehicle-controlled clinical studies in adult DED patients with severe keratitis.6
Professor Fiona Stapleton, from the UNSW School of Optometry and Vision Science, said dry eye can cause severe keratitis and symptoms of discomfort and visual disturbance.10
“Treatment options utilising novel approaches to stabilising symptoms, and addressing the problem at the eye surface, are therefore critical,” she said.
“Whilst the efficacy and safety of Ikervis has been tested in robust clinical trial settings, this study provides important evidence regarding its tolerability and long- term effectiveness in real-world practice in severe keratitis from DED. Optometrists and ophthalmologists should be aware of the signs and symptoms of dry eye, and treat the condition promptly, to help patients manage their eye health and improve overall quality of life.”
- To learn more about the PERSPECTIVE study, watch Prof Geerling’s virtual, live-streamed presentation from Germany to Brisbane, Sydney, Melbourne, and Adelaide respectively today – Wednesday, March 29 – between 8.00pm – 9.00pm AEDT. Prof Geerling’s presentation will be followed by a Q&A session. To register, visit bit.ly/eyecare-perspective
More reading
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New dry eye therapy Cationorm now PBS listed
Dry eye treatment in Australia
*The PERSPECTIVE study collected data from ophthalmology clinics in Finland, Germany, Norway, Sweden and the United Kingdom.3
**While real-world evidence (RWE) and randomised controlled trial (RCT) data are considered mutually complementary, RCTs are generally characterised as more reliable and less biased compared to RWE.11 RWE-based studies offer the benefit of real-world practicality and clinical applicability, with methodology that supplements the rigorous protocols of RCTs.11
References
- Geerling G, et al. Real-World Effectiveness, Tolerability and Safety of Cyclosporine A 0.1% Cationic Emulsion in Severe Keratitis and Dry Eye Treatment. Ophthalmol Ther. 2022;11(3):1101-17.
- Labetoulle M, et al. Persistence of efficacy of 0.1% cyclosporin A cationic emulsion in subjects with severe keratitis due to dry eye disease: a nonrandomized, open-label extension of the SANSIKA Study. Clin Ther 2018;40(11):1894-906.
- Gayton JL. Etiology, prevalence, and treatment of dry eye disease. Clinical ophthalmology (Auckland, NZ). 2009;3:405-12.
- Metis Healthcare Research. Pharmacy Eye Health Quantitative Marketing Research Report. 2022.
- Javadi MJ, Feizi S. Dry Eye Syndrome. J Ophthalmic Vis Res. 2011;6(3):192-8.
- Ikervis Approved Product Information.
- Baudouin C, et al. A randomized study of the efficacy and safety of 0.1% cyclosporine A cationic emulsion in treatment of moderate to severe dry eye. Eur J Ophthalmol. 2017;27(5):520-30.
- Leonardi A, et al. Efficacy and safety of 0.1% cyclosporine A cationic emulsion in the treatment of severe dry eye disease: a multicenter randomized trial. Eur J Ophthalmol. 2016;26(4):287-96.
- Labetoulle M, et al. Ciclosporin A Cationic Emulsion 0.1% for the Management of Dry Eye Disease: Facts That Matter for Eye-Care Providers. Ocul Immunol Inflamm. 2022;29:1-9.
- Lallemand F, et al. Successfully improving ocular drug delivery using the cationic nanoemulsion, novasorb. J Drug Deliv. 2012;2012:604204.
- Kim H, Lee S, Kim J. Real-world Evidence versus Randomized Controlled Trial: Clinical Research Based on Electronic Medical Records. J Korean Med Sci. 2018;33(34):e213.
