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Itinai.com close up of doctor hands doing procedure for patie b62daafd ae78 4416 b629 6e501ccde339 1

Long-Term Safety and Efficacy of a Water-Free Cyclosporine 0.1% Ophthalmic Solution for Treatment of Dry Eye Disease: ESSENCE-2 OLE

Long-Term Safety and Efficacy of a New Dry Eye Treatment

The ESSENCE-2 Open-Label Extension study focused on the long-term safety and effectiveness of a new eye drop treatment for dry eye disease (DED). This treatment is a water-free, non-preserved solution containing cyclosporine 0.1%, known as VEVYE.

Study Overview

This was a Phase 3 clinical trial involving multiple centers. Over the course of a year, all patients used the eye drops twice daily. The study tracked safety by monitoring any side effects and assessed the treatment’s effectiveness through various tests.

Results Summary

A total of 202 patients participated in the study, with 175 completing the full year. Some patients reported mild side effects, with the most common being slight discomfort at the application site. Importantly, patients showed significant improvements in eye health and symptoms over the year:

  • Corneal staining improved early and stabilized.
  • Tear production increased over time.
  • Patients reported better overall symptoms by the end of the year.

Conclusions

The water-free cyclosporine eye drops were found to be safe and well-tolerated for long-term use. The treatment effectively improved both the signs and symptoms of dry eye disease, offering valuable insights into managing this condition.

Opportunities for Clinics and Patients

Based on the trial data, clinics can:

  • Set clear goals for patient outcomes related to the new treatment.
  • Utilize AI tools that cater to specific clinical needs in managing dry eye disease.
  • Implement a step-by-step approach to integrate this treatment into practice, starting with pilot projects to track results.

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