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Hovione has successfully completed the Phase II clinical trial of its ophthalmic formulation of minocycline, Meizuvo.
Hovione has successfully completed the Phase II clinical trial of its ophthalmic formulation of minocycline, Meizuvo, aimed at the treatment of dry eye caused by Meibomian Gland Dysfunction (MGD). The company announced the trial completion at the Ophthalmology Innovation Summit Dry Eye Showcase.
Meizuvo is the first ophthalmic formulation of minocycline in clinical development and targets MGD patients with ocular inflammation demonstrated by an MMP-9 based diagnostic. The Phase II trial, which included 270 patients across 26 clinical sites, assessed two different strengths of minocycline against vehicle in a 1:1:1 randomization.
The trial results demonstrated a statistically significant improvement in the Visual Analogue Scale (VAS) discomfort greater than 50% by the end of treatment for more than two thirds (70%) of patients with positive inflammatory biomarker at baseline. Additionally, a statistically significant improvement in inferior Cornea Fluorescein Staining was seen with both treatment arms versus vehicle at day 57. The product was found to be safe and well-tolerated with less than 3% of patients reporting blurring vision or eye irritation.
“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,” said Carla Vozone, vice-president of the innovative proprietary portfolio at Hovione in a March 17, 2021 press release.
“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,” added George Magrath, CEO of Lexitas Pharma Services, in the press release. “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.”