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- 03/17/2021

Hovione completes its Phase 2 clinical trial of the first minocycline ophthalmic showing promise in Dry Eye Disease associated with Inflamed Meibomian Gland Dysfunction

Chimica Oggi-Chemistry Today

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Hovione announced at the Ophthalmology Innovation Summit (OIS) Dry Eye Showcase the successful completion of its Phase 2 clinical trial in 270 patients with Dry Eye caused by Meibomian Gland Dysfunction (MGD). The well controlled and representative study was conducted across 26 clinical sites in the United States and tested 2 different strengths of minocycline against vehicle in a 1:1:1 randomization. This is the first dry eye therapy targeting MGD patients with ocular inflammation demonstrated by an MMP-9 based diagnostic and the first and only ophthalmic formulation of minocycline in clinical development, contingently named Meizuvo®.

The study observed superior clinical outcome in the 7

Carla Vozone, Vice President of the innovative proprietary portfolio at Hovione commented: “The correlation between the patients with a positive MMP-9 assay at baseline and the clinical improvement observed in both signs and symptoms of dry-eye was groundbreaking”. Ms. Vozone explained that investigational Meizuvo® not only has the potential of adding a much needed treatment specific for assay recognized inflammation, but could also reduce the risk of failure in the pivotal studies by inclusion of the patient sub-set most responsive to the drug. OIS panelists, who shared their Clinical Perspectives, consensually identified chronic inflammation as the underlying cause of Dry Eye Disease highlighting the relevance of diagnostics to recognize such inflammation.

George Magrath, M.D., CEO of Lexitas Pharma Services stated “We were thrilled with the opportunity to work on this exciting project.  Minocycline is a well-known molecule for ophthalmologists and there is significant excitement from the ophthalmology community regarding the potential for a topical alternative.  The results in the overall population were encouraging in both signs and symptoms.  The results in the inflamed group of subjects were impressive with consistent statistically significant results in key dry eye signs and symptoms.”

www.hovione.com