The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for CyclASol® (cyclosporine ophthalmic solution) for the treatment of the signs and symptoms of dry eye disease.

CyclASol contains cyclosporine, and anti-inflammatory and selective immunomodulatory drug. According to Novaliq, the drug’s bioavailability is improved using its proprietary water-free technology. The product does not contain oils or surfactants and is preservative-free.

The NDA is supported by data from multiple clinical studies, including the randomized, double-masked, vehicle-controlled phase 2b/3 ESSENCE-1 (ClinicalTrials.gov Identifier: NCT03292809) and ESSENCE-2 (ClinicalTrials.gov Identifier: NCT04523129) trials, which evaluated the efficacy and safety of CyclASol in over 1000 patients with dry eye disease. Patients were randomly assigned to receive either CyclASol or vehicle.


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In both studies, treatment with CyclASol resulted in statistically significant reductions in total corneal fluorescein staining (tCFS) score (primary endpoint) compared with vehicle. Findings showed that up to 71.6% of CyclASol-treated patients had a clinically meaningful improvement of at least 3 grades in total corneal staining within 4 weeks.

With regard to tear production, a statistically significantly greater percentage of patients treated with CyclASol had increases of 10mm from baseline in Schirmer tear test score compared with vehicle (P <.05). In an open-label extension study (ClinicalTrials.gov Identifier: NCT04523142), the effect of CyclASol was found to be sustained over the 52-week treatment period.

The most common adverse reactions reported were instillation reactions, which were mostly mild in severity.

“If approved, CyclASol would be a highly potent but comfortable anti-inflammatory therapy for patients with dry eye disease,” said Christian Roesky, PhD, CEO, Novaliq. “It shows impressive and rapid therapeutic effects objectively measured on the ocular surface in the majority of patients, with clinical benefits on the signs and symptoms of the disease.”

A Prescription Drug User Fee Act target date of June 8, 2023 has been set for the application.

References

  1. Novaliq announces FDA acceptance of the New Drug Application for CyclASol® for the treatment of dry eye disease. News release. Novaliq. Accessed October 24, 2022. https://www.businesswire.com/news/home/20221024005092/en/Novaliq-Announces-FDA-Acceptance-of-the-New-Drug-Application-for-CyclASol%C2%AE-for-the-Treatment-of-Dry-Eye-Disease
  2. Novaliq submits New Drug Application seeking approval for first-of-a-kind dry eye disease treatment CyclASol®. News release. Novaliq. August 9, 2022. Accessed October 24, 2022. https://www.novaliq.com/press-releases/2022/08/09/novaliq-submits-new-drug-application-seeking-approval-for-first-of-a-kind-dry-eye-disease-treatment-cyclasol/

This article originally appeared on MPR