Positive patient-reported outcomes from a Northern Europe study provide 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.
The prospective, multicentre, observational study, known as PERSPECTIVE, was recently published in Ophthalmology and Therapy. Its findings have 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
Led by Professor Gerd Geerling a Professor of Ophthalmology and Chairman of the Department of Ophthalmology at the University Hospital in Duesseldorf, Germany, the study was conducted at 44 ophthalmology clinics in Finland, Germany, Norway, Sweden, and the United Kingdom.
It recruited a total of 472 participants 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
Professor Stephanie Watson, ophthalmic surgeon and Head of the Corneal Unit at Sydney Eye Hospital, says studies that examine 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.
She said the positive patient-reported outcomes from this study “should contribute to increasing prescriber confidence in the use of Ikervis to treat severe keratitis in dry eye disease”.
Significant Improvements In DED
PERSPECTIVE identified significant improvements in mean corneal fluorescein staining (CFS) score from baseline over the 12-month treatment period (mean change, -1.42;p<0.0001), with incremental reductions observed from week 4.1 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 total AEs (88.6 %) non-serious in nature.1 By the end of the study, most treatment-related AEs (73.%) 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, urning/stinging, itching, pain, blurred vision, sticky feeling and photophobia.1
Symptom severity was recorded using a four-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
Importance Of Real-World Evidence
“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,” Prof 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,” said Prof Watson.
DED is a chronic eye condition and significant health burden in Australia and is likely to affect more than 7% of the population.3 Many living with dry eye attempt to self-manage their symptoms using over-the-counter ATs.4
“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” Prof Watson said.
References
1. 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.
2. 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.
3. Gayton JL. Etiology, prevalence, and treatment of dry eye disease. Clinical ophthalmology (Auckland, NZ). 2009;3:405-12.
4. Metis Healthcare Research. Pharmacy Eye Health Quantitative Marketing Research Report. 2022.
5. Javadi MJ, Feizi S. Dry Eye Syndrome. J Ophthalmic Vis Res. 2011;6(3):192-8.
6. Ikervis Approved Product Information.
**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.6 RWE-based studies offer the benefit of real-world practicality and clinical applicability, with methodology that supplements the rigorous protocols of RCTs.6
