The U.S. Food and Drug Administration (FDA) has notified Ireland-based biopharmaceutical company Shire Plc it will not approve its eye drug Lifitegrast. The U.S. health regulator recommended the company conduct additional clinical studies.

Shire said it received a complete response letter (CRL), which the FDA sends to let a drug maker know a marketing application will not be approved in its present form.

The results of the Lifitegrast's OPUS-3 Trial are scheduled for release before the end of 2015. The company is gearing up to submit the results of the OPUS-3 Trial within the first quarter of 2016 and resubmit the drug for FDA approval.

The company's OPUS-3 Trial involved a randomized test of 711 patients to evaluate the level of efficacy and safety of Lifitegrast. The goal of the 12-week clinical trial is to have a patient-reported improvement of dry eye symptoms using the Eye Dryness Score EDS scale.

Dry eye disease varies when it comes to indicators even though typical symptoms might include gritty feeling, burning sensation, occasional blurred vision and overall discomfort in the eye area.

Dry eye is a disease of the tears and ocular surface and is diagnosed by an eye care specialist. The disease develops when the eye fails to produce tears properly or when the produced tears vaporize too fast or do not have the normal consistency.

A 2011 study analyzed the popularity of dry eye syndrome in a US Veterans Affairs (Miami and Broward Veterans Affairs) population who received regular services for ocular care between 2005 and 2010. The researchers identified 16,862 patients with dry eye cases. There were 2,056 cases of ICD9 dry eye syndrome code with therapy and 14,806 ICD9 dry eye syndrome code without therapy.

It was found that females have a 2.40 greater risk of developing dry eye syndrome when compared to males. The researchers also found that several health conditions such as sleep apnea, depression, thyroid disease and post-traumatic stress disorder increase risk of developing dry eye disease in the Veterans Affairs population. Furthermore, regular use of medications such as anti-anxiety drug, anti-depressants and anti-benign prostatic hyperplasia pills increases the same risk.