Prior Approval Supplement for Restasis Bottle Rejected

Allergan received a complete response letter from the FDA for the manufacturer's prior approval supplement for cyclosporine ophthalmic emulsion, 0.05%, multi-dose preservative-free bottle.

Allergan received a complete response letter from the FDA for the manufacturer’s prior approval supplement for cyclosporine ophthalmic emulsion (Restasis), 0.05%, multi-dose preservative-free bottle.

The FDA asked for more chemistry, manufacturing, and control information regarding the bottle, which has a unidirectional valve and air filter technology.

Allergan said it was working quickly to collect this information for the FDA.

“In the absence of additional data requests from the FDA, Allergan does not anticipate a significant impact to previously communicated timelines of the potential approval of the multi-dose preservative-free bottle,” Allergan wrote in a press release.

Restasis was originally approved by the FDA in 2002 and is designed to treat chronic dry eye in patients, which typically causes reduced tear production due to inflammation. The condition can arise due to aging, contact lens wear, and certain medications.

The most common side effects associated with Restasis are eye redness, discharge, watery eyes, eye pain, and stinging. The product may be used by contact lens users as long as the lenses are not in place during administration.

Currently, the product is packaged in a sterile, preservative-free single-use vial. Patients are advised to avoid physical eye contact with the tip of the vial. Each vial must also be used immediately upon opening, and remaining contents should be discarded.