Published in Research

Water-free cyclosporine shows potential for DED treatment

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3 min read

Results from a new clinical trial of a novel formulation of cyclosporine 0.1%, suggests that a water-free solution could offer improved efficacy in treating dry eye disease (DED) compared with current therapeutics on the market.

Tell me about the drop.

Cyclosporine ophthalmic solution 0.1% (CyclASol [Novaliq GmbH]) is a potent anti-inflammatory and immunomodulatory drug that is soluble in a preservative-, oil-, surfactant- and water-free solution of perfluorobutylpentane (F4H5).

Now talk about the trial.

The phase 3 trial ESSENCE-2 (CYS-004) (NCT04523129) enrolled 834 patients diagnosed with moderate to severe DED.

Patients were randomly assigned 1:1 to be administered either cyclosporine 0.1% in a preservative-, oil-, surfactant- and water-free solution of perfluorobutylpentane (F4H5) or a vehicle, each dosed twice a day for 29 days.

The trial followed a phase 2 dose-finding study that showed promising results when compared to vehicle and cyclosporine 0.05%, emulsion ([Restasis] Abbvie).

What was being measured?

The primary end points of the study were the change in total corneal fluorescein staining (tCFS) and eye dryness score, measured using the National Eye Institute (NEI) scale and a visual analog scale (VAS), respectively.

Investigators also assessed conjunctival staining, central tCFS, and tCFS responders.

Findings?

Researchers identified “responders” as those trial participants who experienced improvement of 3 grades or higher on the NEI scale.

They alsonoted that 71.6% of participants who received the cyclosporine solution were responders compared to those who received the vehicle (59.7%).

Any limitations?

The study authors noted that most of the participants in the trial experienced aqueous-deficient DED, so the outcomes are not necessarily applicable to all dry eye patients.

They also suggest longer-term studies of the treatment on its own as well as in comparison against other formulations or treatments.

Take away.

In an invited commentary, a group of reviewers noted that while the study offers promising results when it comes to corneal staining, neither the eye dryness score nor the Ocular Surface Disease Index (OSDI) score showed marked improvement.

They also raise concerns over the cost of the medication, noting the barrier to entry of existing commercially available treatments due to costs, and urge further exploration into accessible and affordable treatments.


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