Hovione Completes Phase 2 Clinical Trial of First Minocycline Ophthalmic for Dry Eye Disease Associated With Inflamed MGD
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, according to a company news release.
The study observed superior clinical outcome in the 70% of patients with positive inflammatory biomarker at baseline, who achieved statistically significant (P=0.02) improvement of 25 points in the Visual Analogue Scale (VAS) discomfort after 2 weeks of treatment, dropping further to 35 points by the end of treatment (an improvement greater than 50%). The sign endpoint inferior Cornea Fluorescein Staining, which is a measure of corneal damage in dry eye, had a statistically significant improvement against vehicle in both active arms at day 57 (P=0.009). The product was safe and well tolerated with less than 3% of subjects 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,” Carla Vozone, Vice President of the innovative proprietary portfolio at Hovione, said in a company news release.
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.