Real-world clinical effectiveness and safety of cyclosporine eye drop emulsion in patients with dry eye disease and severe keratitis (the PERSPECTIVE study): 24-week interim analysis

Session Details

Session Title: Moderated Poster Session: Cornea

Venue: Poster Village: Pod 2

First Author: : S.Hamada UK

Co Author(s): :    F. Sahin   C. Fassari   I. Lanzl   N. Maycock   M. Zierhut           

Abstract Details

Purpose:

The ongoing PERSPECTIVE study aims to evaluate, in routine clinical practice, the effectiveness, tolerability and safety of cyclosporine (CsA) eye drop emulsion in controlling severe keratitis, in adult dry eye patients who have not improved despite treatment with tear substitutes. The primary study endpoint is treatment effectiveness, from baseline, as measured by change in corneal fluorescein staining (CFS). Secondary endpoints comprise objective and subjective measures of symptom severity. Safety outcomes include reporting of adverse events (AEs) and treatment-related AEs (TRAEs). Data presented are from an interim analysis conducted at 24-weeks.

Setting:

An ongoing, European, non-interventional, multicentre, prospective study in patients attending 29 ophthalmology clinics based in Germany, Finland, Norway, Sweden and the UK.

Methods:

Adults (males and females aged >18 years) with dry eye disease (DED) and severe keratitis who were currently treated with artificial tears were included. Subjects were excluded if they were previously or currently treated with CsA eye drop emulsion or immunosuppressants (within the past 6 months), had undergone ophthalmic surgery or were pregnant. Change in CFS grade (Oxford grade scale), from baseline, was measured from initiation of CsA treatment. Data concerning change in severity of objective and subjective symptoms, from baseline, were reported. These included foreign body sensation, blurred vision and conjunctival erythema.

Results:

The analysis included 154 subjects (78.6% female). Age (mean±SD) was 62.1±15.2 years. Week 24 data showed significant reductions in mean CFS score (1.18±1.12; n=146), from baseline (2.58±1.11; n=154) (P<0.001). CFS grade was improved (77.4%) or maintained (19.9%) for most subjects. Improvement was shown in all subjective symptoms at Week 24, including statistically significant reductions in foreign body sensation (52.5% improved; 29.7% unchanged; P=0.0001; n=101), blurred vision (41.8% improved; 46.9% unchanged; P<0.001; n=98) and conjunctival erythema (45.4% improved; 47.9% unchanged; P<0.001; n=119). Overall, 31 TRAEs were reported; one was considered serious. Most TRAEs resolved.

Conclusions:

In routine clinical practice, CsA eye drop emulsion provided effective treatment with statistically significant reductions in CFS staining at 24 weeks in adults with DED and severe keratitis who had not improved despite treatment with tear substitutes. Significant improvements in symptom severity were observed and the treatment was well-tolerated.

Financial Disclosure:

... is employed by a for-profit company with an interest in the subject of the presentation, ... receives consulting fees, retainer, or contract payments from a competing company, ... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented