FDA Advisory Committees - FDA Center for Drug Evaluation and Research (CDER) - Dermatologic and Opthalmic Drugs Advisory Committee (DODAC)
The Committee supported, by a vote of 9-Yes to 1-No, with no abstentions, the safety and efficacy of Rhopressa (netarsudil ophthalmic solution 0.02%), submitted by Aerie Pharmaceuticals Inc. (Aerie), for the proposed indication to reduce elevated intraocular pressure in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
The Committee supported, by a vote of 14 for “Yes, but only if certain risk management options for Suicide Ideation and Behavior (SIB) beyond labeling are implemented”, the overall benefit/risk profile of brodalumab as acceptable to support approval for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Four of the Committee members voted for “Yes, with labeling alone to manage the risks.” No members voted for “No.”
During the morning session the committee will discuss new drug application (NDA) 206333, deoxycholic acid injection, a cytolytic drug, submitted by Kythera Biopharmaceuticals, proposed for the improvement in the appearance of moderate-to-severe convexity or fullness associated with submental fat in adults.
During the afternoon session, the committee will discuss pediatric development of systemic products for the treatment of atopic dermatitis with inadequate response to topical prescription therapy.
The joint committee split their votes on the safety and efficacy of combination product riboflavin ophthalmic solutions with UV-A irradiation, submitted by Avedro, Inc.
Regarding the recommendation for the combination product’s approval for corneal collagen cross-linking in the treatment of progressive keratoconus, the joint committee voted 10-Yes to 4-No, with 1 abstention. For the indication of treatment for corneal ectasia following refractive surgery, the joint committee voted 6-Yes to 4-No, with 4 abstentions and 1 committee member not voting.
Dermatologic and Opthalmic Drugs Advisory Committee (DODAC)
DODAC reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of dermatologic and ophthalmic disorders and makes appropriate recommendations to the Commissioner of Food and Drugs.