RhofadeRosacea-associated persistent facial erythema (redness) in adults
Development and Regulatory status
Oct 19: Aclaris and EPI Health have entered into a purchase agreement whereby Aclaris sold the worldwide rights to Rhofade® .
Nov 18: On November 30, 2018, Allergan divested Rhofade® to Aclaris Therapeutics, Inc .
May 17: Launched in the US .
Jan 17: Allergan plans to launch Rhofade in the US in May 17 .
Jan 17: Approved in the US for topical treatment of persistent facial erythema (redness) associated with rosacea in adults. Approval was based on two clinical studies that evaluated the primary efficacy endpoint on day 29 .
Trial or other data
Jan 17: PIII trials are NCT01735201 and NCT02131636 .
Jan 17: In two clinical trials, a once-daily application of Rhofade was proven to reduce persistent facial erythema associated with rosacea through 12 hours. The primary efficacy endpoint was at day 29 and defined as the proportion of patients with at least a 2-grade reduction in erythema (improvement) from baseline (pre-dose on day 1) on both the clinician erythema assessment (CEA) and subject self-assessment (SSA) (composite success) measured at hours 3, 6, 9 and 12 versus vehicle. CEA and SSA also measured at Days 1 and 15 at hours 3, 6, 9, and 12. The clinical trials were identical, multicentered, randomized, double-blind, parallel-group, and vehicle-controlled in moderate or severe patients, N=885, 18 years or older. In both pivotal trials, the primary efficacy endpoint was met. The proportion of patients achieving composite success were as follows: at hours 3, 6, 9 and 12 results in study 1 were Rhofade (N=222) 12%, 16%, 18%, 15% versus Vehicle (N=218) 6%, 8%, 6%, 6% and in study 2 were Rhofade (N=224) 14%, 13%, 16% and 12% versus Vehicle (N=221) 7%, 5%, 9% and 6%. Rhofade was proven more effective than vehicle in reducing persistent facial erythema associated with rosacea in adults .