Hovione has launched its first clinical trial and will soon initiate recruitment for the Phase 1 of HY02, a proprietary minocycline sterile ointment to treat a subset of ocular surface inflammation, generally manifesting on the inner edge of the eyelids, leading to eye irritation and sometimes more severe symptoms such as blurring of the vision and/or irritation of the cornea. This first in human study is a double-blinded, randomized trial, which will include three arms and enroll approximately 36 subjects over the next few months. Hovione expects topline results by the end of 2017.

Carla Vozone, vice president of product development and licensing (PDL), Hovione, said it was the first clinical study using a patent protected minocycline API and formulation developed by Hovione. “Hovione has been a leader in tetracycline manufacturing for over 30 years,” he said. “It is rewarding to take minocycline, known systemically for its anti-inflammatory and antibacterial benefits, and apply it locally to the site of action in these patients with significant disease. Moreover, we believe that local delivery will increase exposure to the affected area without the negative adverse events associated with oral delivery.”

Hovione’s minocycline sterile ointment is a proprietary formulation of crystalline minocycline base and oil-based excipients. Hovione has applied for and been granted issued patents for both the API and the drug product. This granted patent portfolio covers both the U.S, and the EU, with other patent applications expected to be granted, expanding the portfolio throughout the world. With the current granted patents, Hovione has exclusivity through 2033.