Trial reportCornea2024
Long-Term Safety and Efficacy of a Water-Free Cyclosporine 0.1% Ophthalmic Solution for Treatment of Dry Eye Disease: ESSENCE-2 OLE.
Trial report in Cornea, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07268599 (Acoltremon Symptom Tracking and Relief Assessment in Moderate-to-Severe Dry Eye Disease), which is not on this map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Acoltremon Symptom Tracking and Relief Assessment in Moderate-to-Severe Dry Eye Disease
Who cites it
6 citing papers in PubMed.
- Pooled results from two pivotal randomized controlled clinical trials: ESSENCE-1 and ESSENCE-2 to assess efficacy and safety of a water-free ciclosporin 0.1% formulation for the treatment of dry eye disease.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025Trial
- Matching-adjusted indirect comparison of acoltremon ophthalmic solution 0.003% and cyclosporine 0.05% ophthalmic emulsion for increased tear production in patients with dry eye disease.Journal of comparative effectiveness research · 2026Article
- Water-Free Cyclosporine 0.1% in Dry Eye Disease: Formulation Rationale, Clinical Evidence, and Unresolved Questions.Drug design, development and therapy · 2026Review
- Real-World Treatment Patterns and Clinical Outcomes with Cyclosporine 0.1% in Semifluorinated Alkane for Dry Eye Disease.Clinical ophthalmology (Auckland, N.Z.) · 2026Article
- Assessment the Safety of CyclASol compared with Vehicle and Commercially Available 0.05% Cyclosporine in Dry Eye Disease: A Systematic Review and Meta-analysis.Ophthalmology and therapy · 2025Article
- Differentiating Between Perfluorohexyloctane Ophthalmic Solution and Water-Free Cyclosporine Ophthalmic Solution 0.1% for Dry Eye Disease: A Review of Preclinical and Clinical Characteristics.Ophthalmology and therapy · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
purposeThe ESSENCE-2 Open-Label Extension study aimed to demonstrate long-term safety, tolerability, and efficacy of a novel water-free, nonpreserved topical cyclosporine 0.1% ophthalmic solution (US brand name VEVYE) for patients with dry eye disease (DED).
methodsThis was a Phase 3, prospective, multicenter, open-label, clinical study. All patients received cyclosporine 0.1% ophthalmic solution and dosed each eye twice a day for 52 weeks. Primary safety end points were ocular and nonocular adverse events (AEs). Secondary safety end points included visual acuity, biomicroscopy, intraocular pressure, and dilated fundoscopy. Efficacy end points, such as total corneal fluorescein staining (tCFS) score (National Eye Institute [NEI] Scale), ocular symptoms (visual analog scale [VAS]), and Schirmer tear test, were also assessed.
resultsA total of 202 patients were enrolled from the ESSENCE-2 study. At week 52, 175 patients (86.6%) completed ESSENCE-2 open-label extension. A total of 55 patients (27.5%) reported 74 ocular treatment-emergent adverse events (TEAEs). The most common ocular AE was instillation site pain (6.5%), which was of mild intensity in all cases. Patients showed statistically significant improvements in all prespecified efficacy end points compared with baseline at each visit. Corneal staining improvements were early and stabilized over time while tear production improved continuously. Symptomatology improvement followed these effects with scores reaching a minimum after 1 year of treatment.
conclusionsThe water-free cyclosporine 0.1% ophthalmic solution was safe and well tolerated during long-term use. The results demonstrated sustained 1-year efficacy, in both signs and symptoms of DED, and may help understand short and long-term healing dynamics in a predominant inflammatory DED population.
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