Hovione has completed the Phase II trial of Meizuvo, a minocycline repurposed for ophthalmic administration, for dry eye disease caused by Meibomian Gland Dysfunction (MGD).
The well controlled and representative study was conducted across 26 clinical sites in the US and included 270 subjects suffering from dry eye associated with MGD.
It tested two different strengths of minocycline against vehicle in a 1:1:1 randomisation.
According to the company, the study observed a favourable clinical outcome in 70% of subjects with positive inflammatory biomarker at baseline.
Following two weeks of treatment, these patients achieved statistically significant improvement of 25 points in the Visual Analogue Scale (VAS) discomfort.
The figure subsequently increased to 35 points by the end of treatment, representing an improvement of more than 50%.
Less than 3% of subjects reported blurring vision or eye irritation, indicating that the product is safe and well tolerated.
Hovione innovative proprietary portfolio vice-president Carla Vozone said: “The correlation between the patients with a positive [matrix metalloproteinase] MMP-9 assay at baseline and the clinical improvement observed in both signs and symptoms of dry-eye was groundbreaking.”
MGD is an eye condition where the eyelid glands alter the lipid composition of the tears and triggers evaporation-induced tear hyperosmolarity.
In the US, around 27 million people suffer from evaporative dry eye, which is largely caused by MGD.
Hovione offers services for drug substance, drug product intermediate and drug product. The company has manufacturing plants in the US, Portugal, Macau and Ireland.