Water-free cyclosporine solution shows efficacy in treating dry eye signs, symptoms
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Key takeaways:
- A water-free cyclosporine 0.1% solution showed efficacy in improving dry eye signs and symptoms.
- Tolerability, rapidity and magnitude of improvement are potential differentiators to existing therapies.
A water-free cyclosporine solution showed efficacy in improving the signs and symptoms of dry eye disease in a randomized clinical trial.
The preservative-free formulation, formerly known as CyclASol and recently approved as Vevye (Novaliq), contains cyclosporine 0.1% dissolved in perfluorobutylpentane, a non-aqueous liquid used as a vehicle for water-insoluble substances. In the phase 3 ESSENCE-2 study, the cyclosporine solution was compared with vehicle alone in participants with moderate to severe dry eye disease (DED) at 27 clinical sites in the U.S.
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The 834 participants were randomly assigned to receive the cyclosporine solution or vehicle, one drop twice a day for 29 consecutive days.
At day 29, a greater improvement from baseline in total corneal fluorescein staining (tCFS) measured using the National Eye Institute scale was observed in the cyclosporine group (–4.0 grades reduction) vs. the vehicle group (–3.6 grades reduction). Dryness score assessed by a visual analog scale ranging from 0 (no discomfort) to 100 (maximal discomfort) improved in both groups, with –12.2 points in the cyclosporine group and –13.6 points in the vehicle group. In the cyclosporine group, 71.6% of participants responded to the therapy with a reduction of three grades or higher in tCFS vs. 59.7% in the vehicle group. The effects of therapy reached statistical significance at day 15 for tCFS, “which is substantially faster than reported results with other products,” the authors noted.
Instillation of the cyclosporine solution was comfortable, and treatment-emergent adverse events were mainly mild and similar between the groups. “This tolerability profile addresses an unmet need in DED therapy,” the authors wrote.
“Rapidity and the magnitude of improvements on the corneal epithelial damage are potential differentiators to existing therapies. More data from clinical practice would be beneficial in understanding the potential of this treatment,” they wrote.
Perspective
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In the wide spectrum of patients with dry eye disease, there are some who respond favorably to anti-inflammatory agents. Two prescription eye drops in which the active ingredient is cyclosporine are currently available for the treatment of dry eye. One, Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan), has been around for many years. The more recent one is Cequa (cyclosporine ophthalmic solution 0.09%, Sun Pharmaceutical). There is also a 0.1% cyclosporine formulation available with the brand name of Verkazia (Santen), which is approved to treat atopic keratoconjunctivitis but is not approved for dry eye. Current cyclosporine eye drops have their problems, in the sense that not all patients respond well to cyclosporine, and those who do respond quite often experience side effects, especially with the older emulsion.
For a long time, we have been looking for more effective and better-tolerated anti-inflammatory medications. Here, we have a study looking at a novel 0.1% cyclosporine formulation. This would be the strongest cyclosporine concentration we have for dry eye. This study shows that it is effective and potentially better tolerated, as it had a reasonable side effect profile. The vehicle used in the product likely plays a role in its tolerability. How is it going to change the field? It will give us one more cyclosporine option. We need to figure out which patients are going to best respond to it and compare this new formulation with the other two, looking at both efficacy and tolerability.
We get a lot of data from clinical studies, but there is nothing like real-world experience. When this new option enters our clinical practice, we will have a much better sense of how well it is tolerated.
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