In this Contemporary Pediatrics® interview, Rupa Wong, MD, discusses the recent FDA approval of phentolamine ophthalmic solution 0.75% eye drops to treat pharmacologically-induced mydriasis, and how this could impact the treatment landscape for the pediatric population. [Editor's note: RYZUMVI was previously known as Nyxol, which is referenced in the interview.]
Results from the phase 3 MIRA-4 pediatric trial demonstrated a favorable safety and tolerability profile with no reported adverse events. Rupa Wong, MD, offers thoughts on the approval, and why it may not change day-to-day practice when it comes to the pediatric population.
Positive topline results from a pair of identical phase 3 trials support the submission of a supplemental New Drug Application to the FDA for Arcutis Biotherapeutics’ roflumilast cream 0.15%, a once-daily topical to treat mild to moderate atopic dermatitis (AD) in children 6 years or older.
Based on recent positive phase 3 results, Arcutis Biotherapeutics,. intends to submit a supplemental New Drug Application with the FDA for roflumilast cream 0.05% to treat mild to moderate atopic dermatitis in children aged 2 to 5 years.