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FDA Approves Lastacaft

FDA Approves Lastacaft (alcaftadine ophthalmic solution) for Prevention of Itching Associated with Allergic Conjunctivitis

July 28, 2010 -- The United States Food and Drug Administration (FDA) has approved Lastacaft (alcaftadine ophthalmic solution) for the prevention of itching associated with allergic conjunctivitis in patients over 2 years of age.

Alcaftadine is an H1 histamine receptor antagonist which also inhibits the release of histamine from mast cells.

The recommended dosage of Lastacaft is one drop to be instilled into each eye once daily.

Lastacaft should not be used to treat contact lens-related irritation.

In clinical trials, the most common side effects (occurring in < 4% of Lastacaft-treated eyes) were eye irritation, burning and/or stinging on instillation, eye redness, and eye itching.

The most common non-ocular side effects (occurring in < 3% of patients with Lastacaft-treated eyes) were nasopharyngitis, headache and influenza.

Lastacaft will be marketed by Vistakon Pharmaceuticals LLC and packaged in 5-mL bottles containing 3 mL alcaftadine ophthalmic solution 0.25% (2.5 mg/mL) preserved with benzalkonium chloride.

Posted: July 2010

Lastacaft (alcaftadine) FDA Approval History