Dermatologic and Ophthalmic Drugs Advisory Committee

Dermatologic and Ophthalmic Drugs Advisory Committee
Meeting on February 27, 2012, from 9 a.m. to 5 p.m.

Agenda: The committee will be asked to comment on the following topics related to the use of ophthalmic drug products (products intended for use in the eye): (1) Appropriate types of clinical evidence for developing anti-inflammatory drugs for the treatment of postoperative inflammation and reduction of ocular (eye) pain in patients who have undergone ocular surgery. This will include a discussion of the definition and scope of this indication as well as the types of clinical trials needed to support approval; and (2) appropriateness of marketing a single bottle of ophthalmic product for use in both eyes for postsurgical indications as it relates to the potential risk for infection. FDA’s Center for Drug Evaluation and Research would like the advisory committee to provide advice on the potential risk and approaches to mitigating that risk, including limits to fill size where appropriate