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Novaliq submits New Drug Application seeking approval for first-of-a-kind Dry Eye Disease Treatment CyclASol®

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Novaliq submits New Drug Application seeking approval for first-of-a-kind Dry Eye Disease Treatment CyclASol®

Novaliq submits New Drug Application seeking approval for first-of-a-kind Dry Eye Disease Treatment CyclASol

HEIDELBERG, Germany, and CAMBRIDGE, MA, Aug. 9, 2022 /PRNewswire/ Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol water-free technology, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for CyclASol (cyclosporine ophthalmic solution), a proposed novel treatment for the signs and symptoms of dry eye disease (DED). CyclASol has demonstrated in two pivotal studies fast onset of therapeutic effect in the indication, clinical meaningful improvement of ocular surface damage, and excellent tolerability. Results from a 12-month long-term study confirmed that the effects are maintained, and even improved for most sign and symptom endpoints. "This is the first submission of a novel product category of water-free topical drug therapies utilizing EyeSol as a drug carrier", said Christian Roesky, Ph.D., CEO, Novaliq. "CyclASol is a f

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