The U.S. Food and Drug Administration (FDA) formally declined Shire's dry eye disease drug Lifitegrast. The government agency requested further clinical tests along with more information about product quality.
The drug company has completed Lifitegrast's OPUS-3 Trial (Phase 3 study) and will use this to respond to FDA's complete response letter (CRL). Along with further clinical tests, the FDA also requested detailed information associated with product quality. The results of the OPUS-3 Trial are scheduled for release before the year ends. Shire 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.
"We will work quickly to address the FDA's requests related to Lifitegrast, as we are committed to delivering a new prescription treatment option for the 29 million adults in the U.S. living with the symptoms of this chronic and progressive disease," said Shire's Research and Development head, Philip J. Vickers Ph.D.
Shire's OPUS-3 Trial involved a randomized test of 711 patients to assess the level of safety and efficacy 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 in adults varies when it comes to indicators albeit typical symptoms may include stinging, gritty feeling, occasional blurred vision, burning sensation, eye dryness 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. This disease develops when the eye fails to produce tears properly or when the produced tears do not have the normal consistency or vaporize too fast.
A 2011 study looked into 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. 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.
The researchers found females have a 2.40 greater risk of developing dry eye syndrome compared to males. They also discovered that several health conditions such as depression, thyroid disease, sleep apnea and post-traumatic stress disorder increase risk of developing dry eye disease in the Veterans Affairs population. Moreover, regular use of medications such as anti-depressants, anti-benign prostatic hyperplasia pills and anti-anxiety drug increases the same risk.
External factors such as excessive computer usage, sunlight, humidity, allergies and low humidity can aggravate dry eye disease in adults. Left untreated, dry eye disease can lead to ocular damage.
