FDA to review Shire's second New Drug Application for dry eye therapy
The FDA has deemed the application complete and now has six months to review it. Action is expected on or before July 22.
“The resubmission is an important milestone for Shire and our commitment to providing a new treatment option for the 29 million adults in the U.S. living with the symptoms of dry eye disease,” Dr. Philip Vickers, head of research and development for Shire, said. “We believe that this resubmission package -- which includes our positive OPUS-3 data, as well as information about product quality -- will address the requests from the FDA. Ophthalmics is a key focus area for Shire, and we’re pleased to see our lead candidate continue to advance."
Dry eye is a disease of the tears and ocular surface marked by eye dryness, overall eye discomfort, stinging, burning, gritty feeling or fluctuating blurry vision and other signs that can be diagnosed by an eye care professional.
Lifitegrast was the subject of five clinical trials: one Phase II study, three Phase III safety and efficacy studies (OPUS-1, OPUS-2 and OPUS-3) and one long-term Phase III safety study (SONATA). These studies involved more than 2,500 patients.