Novaliq Reports the EMA Acceptance of MAA for CyclASol (ciclosporin ophthalmic solution) to Treat Dry Eye Disease
Shots:
- The EMA has accepted the MAA for CyclASol (ciclosporin ophthalmic solution). The MAA was based on the 6 clinical studies evaluating the safety and efficacy of CyclASol in 1575 patients with dry eye disease
- The results from the two registrational studies (ESSENCE-1 & 2) showed that CyclASol was effective for the treatment of DED while continued improvement in both signs and symptoms has been clinically demonstrated over a period of ~56wks. in an extension study of (ESSENCE‑2)
- CyclASol was approved in the US as Vevye (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease on May 2023
Ref: Businesswiree | Image: Novaliq
Related News:- Novaliq Presents Results of Cyclasol in P-III (ESSENCE-2) Trial for the Treatment of Dry Eye Disease at ASCRS 2022
The EMA accepted the MAA for Novaliq’s CyclASol (ciclosporin ophthalmic solution) to treat dry eye disease, based on the 6 clinical studies
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