Phase 2 trial of 0.3% minocycline microparticle suspension shows promise in dry eye diseases associated with Inflamed meibomian gland dysfunction
Hovione has completed a Phase 2 clinical trial of 0.3% minocycline microparticle suspension in 270 patients with dry eye caused by meibomian gland dysfunction (MGD).
The results were presented by Courtney Smith, director of Business Development and Licensing at Hovione, at the Ophthalmology Innovation Summit (OIS) Dry Eye Showcase.
Smith noted that minocycline is known in ophthalmology for its anti-inflammatory property.
“Inflammation of the ocular surface, left untreated, may cause a decrease in corneal barrier function, exacerbating dry eye disease,” she said.
According to Smith, the 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 randomly assigned study.
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 Smith, the study demonstrated a positive 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.
According to Carla Vozone, vice president of the innovative proprietary portfolio at Hovione, 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.
Vozone explained in a statement that the investigational drug 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.
The OIS panel offered its clinical perspectives, identifying chronic inflammation as the underlying cause of dry eye disease and highlighting the relevance of diagnostics to recognize such inflammation.
According to George Magrath, MD, CEO of Lexitas Pharma Services minocycline is a well-known molecule for ophthalmologists and there is significant excitement from the ophthalmology community regarding the potential for a topical alternative.
“The results in the overall population were encouraging in both signs and symptoms,” he said. “The results in the inflamed group of subjects were impressive with consistent statistically significant results in key dry eye signs and symptoms."