European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2026
Long-term clinical outcomes of 0.015 % tacrolimus HPβCD eye drops in ocular surface inflammatory disorders.
СтатьяНазвание и аннотация: Перевод в очереди
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Puente-Iglesias María, Cuartero-Martínez Andrea, Touriño-Peralba Rosario, Rodríguez-Ares María Teresa, Giráldez María Jesús, Yebra-Pimentel Eva, Torres-Sangiao Eva, González-Barcia Miguel, Zarra-Ferro Irene, Otero-Espinar Francisco J, Fernández-Ferreiro Anxo, Castro-Balado Ana
Аннотация
BACKGROUND: Topical tacrolimus offers potent anti-inflammatory effects across a spectrum of ocular surface diseases, but its ophthalmic use has been limited by formulation challenges. This study evaluated 0.015 % tacrolimus/hydroxypropyl-β-cyclodextrin eye drops (TCD) long-term performance.
METHODS: In a prospective, open-label, sequential design, 56 patients treated ≥6 months with 0.03 % tacrolimus ethanol-based formulation (TE) were switched to TCD and followed for 12 months. Assessments of efficacy and safety at baseline (TE) and month 12 (TCD) included concomitant corticosteroid use, distance best-corrected visual acuity, slit-lamp grading of conjunctival and corneal signs, Oxford staining, tear meniscus height (TMH), non-invasive break-up time, ocular redness, intraocular pressure, NEI VFQ-25 (National Eye Institute Visual Function Questionnaire) scores, symptom visual analog scales and adherence. In addition, a comparative evaluation of microbiological stability in use was performed for both eye drops.
RESULTS: Concomitant corticosteroids declined from 21.4 % to 5 %; two-thirds of eyes maintained or improved visual acuity; ≥80 % showed stable or improved (TMH p<0.0001) corneal/conjunctival. TMH increased significantly (median 0.25 to 0.29 mm; p<0.0001), while break-up time and intraocular pressure remained stable. VFQ-25 total score rose from 82.8 to 87.8 (p<0.001); burning, photophobia and foreign-body sensation decreased (p<0.05), thereby promoting adherence to treatment. Both tacrolimus formulations were similarly contaminated due to improper manipulation by the patients.
CONCLUSIONS: The 0.015 % tacrolimus/HPβCD formulation proves efficacy, and safety over 12 months for the treatment of diverse ocular inflammatory conditions, delivering sustained clinical stability and patient-reported benefits with reduced steroid reliance.
METHODS: In a prospective, open-label, sequential design, 56 patients treated ≥6 months with 0.03 % tacrolimus ethanol-based formulation (TE) were switched to TCD and followed for 12 months. Assessments of efficacy and safety at baseline (TE) and month 12 (TCD) included concomitant corticosteroid use, distance best-corrected visual acuity, slit-lamp grading of conjunctival and corneal signs, Oxford staining, tear meniscus height (TMH), non-invasive break-up time, ocular redness, intraocular pressure, NEI VFQ-25 (National Eye Institute Visual Function Questionnaire) scores, symptom visual analog scales and adherence. In addition, a comparative evaluation of microbiological stability in use was performed for both eye drops.
RESULTS: Concomitant corticosteroids declined from 21.4 % to 5 %; two-thirds of eyes maintained or improved visual acuity; ≥80 % showed stable or improved (TMH p<0.0001) corneal/conjunctival. TMH increased significantly (median 0.25 to 0.29 mm; p<0.0001), while break-up time and intraocular pressure remained stable. VFQ-25 total score rose from 82.8 to 87.8 (p<0.001); burning, photophobia and foreign-body sensation decreased (p<0.05), thereby promoting adherence to treatment. Both tacrolimus formulations were similarly contaminated due to improper manipulation by the patients.
CONCLUSIONS: The 0.015 % tacrolimus/HPβCD formulation proves efficacy, and safety over 12 months for the treatment of diverse ocular inflammatory conditions, delivering sustained clinical stability and patient-reported benefits with reduced steroid reliance.