Micro Labs gets CDSCO Panel Nod to manufacture and market Lifitegrast 5% eye drops

This came after the firm presented Phase-III clinical trial report before the committee.

Lifitegrast is in a class of medications called lymphocyte function-associated antigen-1 (LFA-1) antagonist. Lifitegrast works by reducing the swelling in the eye tissues.

Lifitegrast ophthalmic solution 5% is labeled for the treatment of dry eye disease, also known as keratoconjunctivitis sicca. It is an inhibitor of the lymphocyte function–associated antigen 1 (LFA-1) and has been shown to reduce immune-mediated inflammation.

Lifitegrast binds to the integrin lymphocyte function-associated antigen-1 (LFA-1), a cell surface protein found on leukocytes, and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1). ICAM-1 may be overexpressed in corneal and conjunctival tissues in dry eye disease. LFA-1/ICAM-1 interaction can contribute to the formation of an immunological synapse resulting in T-cell proliferation/activation and migration to target tissues. In vitro studies demonstrated that lifitegrast may inhibit T-cell adhesion to ICAM-1 in a human T-cell line and may inhibit the secretion of inflammatory cytokines, inflammatory mediators, chemokines, TNF-α, and IL-1 in human peripheral blood mononuclear cells.

At the recent SEC meeting for Ophthalmology held on 26th April 2023, the expert panel reviewed the Phase III clinical trial report presented by the drugs major Micro Labs.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market Lifitegrast 5% eye drops with the condition that the drug should be sold by retail under the prescription of an Ophthalmologist only.