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Phase 3 study demonstrates efficacy of new dry eye treatment
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AMSTERDAM — Lifitegrast, a new integrin-antagonist molecule, demonstrated to be well tolerated and effective in relieving dry eye symptoms in a phase 3 study.
“Chronic inflammation is widely accepted as responsible for the cycle that causes many types of dry eye disease. Lifitegrast blocks T-cell activation, proliferation, adhesion and migration, a key step in the chronic dry eye inflammatory cycle,” John Sheppard, MD, said at the European Society of Cataract and Refractive Surgeons meeting.
John Sheppard
This molecule has been optimized for use in the eye. In a phase 2 trial, the 5% dilution proved to be the most effective and well tolerated and produced significant improvement of symptoms in a large cohort of patients.
“In the first phase 3 trial, where 588 subjects were included, we found that the primary objective endpoint, the inferior corneal staining score (ICSS), was significantly improved at day 84. However, the visual-related function subscale score of the Ocular Surface Disease Index (VR-OSDI), which was the co-primary subjective endpoint, was not met,” Sheppard said.
This was probably due, he said, to a floor effect, since the study did not include enough patients with significant symptomatology, allowing the improvement to be statistically significant.
“We are excited about the second phase 3 trial, which has completed enrollment of one month early. It will include more patients with significant symptomatology and will look at ocular dryness and discomfort as primary endpoints,” Sheppard said.
The patients in the new study are also previous users of artificial tear. According to Sheppard, they are for this reason “an even more robustly responsive population to this particular therapy.”
Disclosure: Sheppard has no relevant financial disclosures.