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Dry eye disease signs and symptoms significantly reduced in a routine clinical practice setting with ciclosporin A 0.1% cationic emulsion – results from real-world evidence study, PERSPECTIVE, now published

Wed 30 March 2022

For healthcare professional and pharmaceutical trade media

Santen EMEA is pleased to announce the results of PERSPECTIVE, a real-world evidence study evaluating the long-term treatment of severe keratitis in adult dry eye disease (DED) patients. The study, which was conducted across 44 ophthalmology clinics in 5 European countries, demonstrated that ciclosporin A (CsA) 0.1% cationic emulsion (CE) provided statistically significant reductions in the severity of the signs and symptoms of DED. This was in patients whose condition was insufficiently controlled despite use of artificial tear (AT) products and the results were evident from week 4 and sustained over 1 year of treatment.1 The study results have been published in Ophthalmology and Therapy.

“Dry eye disease is a complex and chronic condition that can be very challenging to diagnose and treat. It requires long-term management and if left untreated can result in permanent ocular damage,” explains Professor Geerling, Director, Department of Ophthalmology, University Hospital Düsseldorf. “The PERSPECTIVE study has not only shown that ciclosporin A 0.1% cationic emulsion is well tolerated, but that all findings were consistent with previous clinical studies. With dry eye disease representing a significant quality of life and economic burden to patients, due to the loss of productivity and impact on how daily tasks are performed, the study results are encouraging for the management of this condition in the real world.”

PERSPECTIVE is a prospective, 12-months, pan-European, multi-centre, observational study that included 472 patients (75.9% female) from Germany, the UK, Sweden, Norway and Finland. The study examined in a real-world clinical practice setting the effectiveness, tolerability and safety of CsA 0.1% CE in adult DED patients, who had not improved despite treatment with ATs. Adults treated with ATs for severe keratitis and DED received CsA 0.1% CE therapy (one drop in both eyes at bedtime) and were followed up at weeks 4, 12 and 24 and at month 12.1 The primary endpoint was mean (standard deviation [SD]) change from baseline in corneal fluorescein staining (CFS; Oxford Grade Scale) at month 12. Secondary endpoints examined ocular sign and symptom severity and adverse events (AEs). Key findings include:1

  • Mean (SD) CFS score at month 12 was 1.10 (1.13), representing a statistically significant mean (SD) change from baseline (2.56 [1.10]) of 1.42 (1.16; P<0.0001). 
  • CFS score reductions were statistically significant from week 4 with further incremental decreases reported at study visits through to month 12 (P<0.0001). 
  • Eyelid erythema and conjunctival erythema were significantly reduced in severity, compared with baseline, from week 4 and at all study visits through to month 12 (P<0.001).
  • Tear film breakup time was significantly increased, versus baseline, from week 4 through to month 12 (P<0.001).
  • Treatment tolerability was good and consistent with previous CsA 0.1% CE clinical studies.
  • Overall, 101 treatment-related AEs were reported. Most were mild/moderate (83.6%) and resolved by month 12 (73.3%).

“Patients are at the heart of everything we do. Real-world evidence studies, such as PERSPECTIVE, are critical in helping us understand how we can make a meaningful difference to the lives of patients,” said Dr Ioana Grobeiu, Vice President, Medical Affairs, Santen EMEA. “The PERSPECTIVE study demonstrated significant reductions in the severity of symptoms, including foreign body sensation, burning, stinging, itching, eye pain, blurred vision and photophobia from week 4, that were sustained through to month 12. The findings of this study represent a positive step forward in how the signs and symptoms of this chronic disease can be managed.” 

DED is often under-recognised and under-treated, yet it affects approximately 11–30% of people in Europe and this prevalence is set to increase with a growing ageing population.2-7 Following the first wave of infections due to COVID-19, Santen EMEA surveyed 502 people suffering from DED across 5 European countries and found that half of survey respondents (47%) are seeking a recommendation for better relief.8 This research, available here, provides insight into the impact of COVID-19 on the quality of life of people with DED, as well as other valuable findings for ophthalmologists. 

References

  1. Geerling, G et al. Ophthalmol Ther 2022. Available at: https://doi.org/10.1007/s40123-022-00487-x. Online ahead of print.  
  2. Clayton JA. NEJM 2018;378:2212-2223.
  3. Viso E et al. Ophthalmic Epidemiol 2009;16:15–21.
  4. Viso E et al. Invest Ophthalmol Vis Sci 2012;53:2601–2606.
  5. Vehof J et al. Br J Ophthalmol 2014;98:1712–1717.
  6. Tsubota K et al. Int J Mol Sci 2020;21:9271.
  7. Malet F et al. Acta Ophthalmol 2014;92:e429–e436.
  8. Barabino S. Ophthalmol Ther 2021;10(3):495–507.

About Santen 
As a global specialised company dedicated to ophthalmology, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices that benefit patients in over 60 countries. Santen’s long-term vision is to become a social innovator in ophthalmology and address social and economic issues related to eye health by strategically exploring advancing technologies and collaborating with key leaders around the world. Underpinned by its people-centric values, Santen aims to ultimately deliver happiness with vision – a life with the best vision experience for every individual around the world. With scientific knowledge and organisational capabilities nurtured over 130 years, Santen provides products and services to contribute to the well-being of patients, their loved ones and consequently to society. For more information, please visit Santen’s websites www.santen.eu (Europe, Middle East and Africa, EMEA) and www.santen.com (Japan headquarters).

Document number: NP-IKERVI-EMEA-0100
Date of preparation: March 2022