According a company release, lifitegrast (Shire Plc), experimental ophthalmic solution for symptoms and signs of dry eye ailment in adults, has been disapproved bythe US Food and Drug Administration (FDA) for now.

The company said that the FDA requested an extra clinical study and more information related to the quality of product in a response letter.

The company explains in a news release that Lifitegrast joins to the integrin lymphocyte function which is associated to antigen-1 (LFA-1), a cell surface protein that initiates on leukocytes, and blocks the interface of LFA-1 with its similar ligand intercellular adhesion molecule-1 (ICAM-1).

Medscape Medical Newspreviously reported that the drug got varied results in two phase 3 trials. In OPUS-1, the drug enhanced signs but not for symptoms of the dry eye, and the next one, OPUS-2, it enhanced symptoms but not signs.

In April 2015, Lifitegrast was granted precedence review status by the FDA.

Shire said it lately completed an additional phase 3 study of lifitegrast which is known as OPUS-3, which is anticipated to form the foundation of the company's response to the response letter.

The OPUS-3 trial was a 12-week study assessing the safety and efficiency of lifitegrast in 711 patients with dry eye ailment. The main point was patient reported symptom enhancement in eye dryness. The company said OPUS-3 results are expected by the end of this year.

Shire Chief Executive Officer Flemming Ornskov, MD, said in a different news release,“If the study is positive, we plan to refile our lifitegrast submission in the first quarter of 2016, and will remain on track for the planned lifitegrast launch next year”.