Clinical trial launched for eye ointment offering topical delivery of antibiotic

Hovione has announced the launch of its Phase I clinical trial of its minocycline sterile ointment, HY02, for the treatment of a subset of ocular surface inflammation.

The study will be a double-blind, randomised trial, including three arms. It is anticipated that about 36 patients will be enrolled over the next few months and top line results should be seen by the end of the year.

HY02 is a topical formulation of a tetracycline antibiotic — compounds that have been used to combat diseases with inflammatory reactions. Minocycline, in particular, features increased lyophilicity when compared with other tetracyclines, which aids its anti-inflammatory capabilities.

“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,” said Carla Vozone, vice president of product development and licensing (PDL) ay Hovione. “Moreover, we believe that local delivery will increase exposure to the affected area without negative adverse events associated with oral delivery.”

“Ophthalmologists and optometrists have respected the numerous beneficial effects of tetracycline class agents upon the ocular surface, the corneal epithelium and stroma, the Meibomian glands, the lid margins and the peri-ocular skin. Despite systemic side effects, oral doxycycline and minocycline are commonly prescribed for a wide variety ocular and cutaneous diseases,” stated Dr John Sheppard, clinical investigator for Hovione’s Phase I trial. “Ancillary anti-collagenolytic, anti-MMP9, anti-inflammatory and lipolytic activities of this antibiotic class have proven beneficial for literally millions of patients. The prospect of an effective topical agent like minocycline is truly exciting, and will provide safer access to this highly respected and understandably underutilised therapeutic agent.”