New Hope for Dry Eye: FDA Approves Lifitegrast, a Novel Treatment

For individuals living with inherited retinal diseases (IRDs), managing overall eye health is paramount. Dry eye disease, a common and often debilitating condition, can significantly impact comfort, vision quality, and daily life for many in our community. That's why the recent U.S. Food and Drug Administration (FDA) approval of lifitegrast (brand name Xiidra) in July 2016 for the treatment of both the signs and symptoms of dry eye disease in adults marks a significant development. This approval, announced by Shire, brings a new therapeutic option to patients who have long sought effective relief.

Dry eye disease, which affects an estimated 16 million adults in the U.S., can cause discomfort, blurred vision, and light sensitivity. While dry eyes do not directly cause retinal disease, chronic dry eye can lead to inflammation and corneal complications that may indirectly affect the quality of the image projected onto the retina and exacerbate symptoms in individuals with pre-existing retinal conditions. Therefore, advancements in treating dry eye are particularly relevant for those navigating the complexities of IRDs.

Key Facts about Lifitegrast (Xiidra)

  • First of its Kind: Lifitegrast is the first prescription eye drop approved by the FDA specifically to treat both the signs and symptoms of dry eye disease.
  • Mechanism of Action: Lifitegrast works by binding to LFA-1, a protein found on immune cells, and blocking its interaction with ICAM-1. ICAM-1 can be overexpressed in the corneal and conjunctival tissues in dry eye disease. This interaction contributes to inflammation in dry eye disease.
  • Clinical Efficacy: The approval was based on four placebo-controlled studies involving 1,181 adult patients. These studies showed that patients treated with lifitegrast twice daily experienced a significant reduction in eye dryness symptoms, with improvement reported as early as two weeks in some studies.
  • Side Effects: The most common side effects reported were eye irritation, discomfort or blurred vision upon instillation, and an altered sense of taste (dysgeusia).
  • Availability: Shire anticipated launching lifitegrast in the United States in the third quarter of 2016.

What This Means for Patients and Families

The introduction of lifitegrast offers a new avenue for managing a condition that significantly impacts quality of life. For individuals with IRDs, effectively addressing dry eye symptoms can lead to improved comfort, potentially better visual function, and a reduction in the compounding challenges of living with multiple ocular conditions. This approval provides another tool for eye care professionals to tailor treatment plans, potentially reducing reliance on artificial tears and improving overall eye health.

Looking Ahead

The approval of lifitegrast highlights ongoing innovation in ophthalmology. As research continues, the IRD community remains hopeful for further advancements that address both the primary challenges of retinal degeneration and co-occurring conditions like dry eye, ultimately enhancing the well-being of patients and families.