Irish pharmaceutical company Allergan has received a complete response letter from the U.S. Food and Drug Administration (FDA), giving Restasis, a therapy for chronic dry eye disease, a prior approval supplement.
The supplement is for .05-percent, multi-dose, preservative-free (MDPF) containers of Restasis. This dosage is delivered with a unidirectional valve and air filter technology.
The FDA has requested further information on the dosing method. Allergan representatives said they will respond to the FDA soon.
Restasis was originally approved in 2002 by the FDA. To date, it is the only product of its kind on the market: an eye drop that can increase the natural ability of the eyes to produce tears.
Chronic dry eye disease is marked by inflammation that leads to decreased tear production. The condition’s causes are varied and include age, contact lens use, medications, eye disease or environmental conditions. Once the disease advances, it can lead to the breakdown of the film that protects the eyes and dry spots on the corneas.
More information about Allergan and its products is available online at www.allergan.com.
