CHMP recommends Vevizye (cyclosporine 0.05 in SFA) to treat dry eye disease – Novaliq GmbH

On 25 July 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Vevizye, intended for the treatment of dry eye disease. The applicant for this medicinal product is Novaliq GmbH.

Vevizye will be available as 1 mg/ml eye drops solution. The active substance of Vevizye is ciclosporin, an ophthalmological (ATC code: S01XA18) which has anti-inflammatory and immunosuppressive properties.

In a main study, the benefit of Vevizye was a reduction in corneal surface damage in patients with dry eye disease, as evidenced by an improvement in the total corneal fluorescein staining score compared to the placebo group. The most common side effects with Vevizye are instillation site reactions and blurred vision.