On May 16, 2018 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, reported data of interest featured in posters at the International Investigative Dermatology (IID) 2018 Meeting in Orlando, Florida (Press release, Aclaris Therapeutics, MAY 16, 2018, View Source [SID1234526680]). Two posters relate to ESKATA (hydrogen peroxide) topical solution, 40% (w/w), known formerly as "A-101", and one poster describes pre-clinical studies of soft Janus kinase 1/3 inhibitors synthesized by Aclaris and designed for high skin permeability with minimal systemic stability.
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A-101 (hydrogen peroxide) topical solution Safety and Efficacy in Patients with Seborrheic Keratoses: Results from two Identical Randomized, Double-blind, Placebo-controlled, Phase 3 Studies
Abstract 465
Authors: L. Baumann, A. Blauvelt, Z. Draelos, S. Kempers, M. Lupo, J. Schlessinger, S. Smith, D. Wilson, M. Bradshaw, E. Estes and S.D. Shanler
Study sponsored by Aclaris
Ex-vivo Evaluation of Cytotoxicity and Melanocyte Viability of Fitzpatrick V Skin after A-101 hydrogen peroxide topical solution 40% or Cryosurgery Treatment in Seborrheic Keratosis Lesions
Abstract 1281, E-poster Discussion I, 5/17/18, 12:15 – 1:15 PM
Authors: S. Kao, A. Kiss, T. Efimova, A. Friedman (Department of Dermatology at The George Washington University School of Medicine & Health Sciences)
Supported by an independent grant from Aclaris
JAK Kinase Inhibitors Efficacious in Models of Murine Contact Hypersensitivity
Abstract 1064
Authors: P. Changelian, S. Mnich, C. Xu, S. Hockerman, D. Anderson, J. Jacobsen and J. Monahan
Authors are employees of Aclaris
The abstracts are available in the Journal of Investigative Dermatology, Volume 138, Issue 5, Supplement, May 2018.
About ESKATA
ESKATA (hydrogen peroxide) topical solution, 40% (w/w), is the first and only FDA-approved medication for the treatment of raised seborrheic keratoses (SKs).
Important Safety Information and Approved Use
ESKATA can cause serious side effects, including:
Eye problems. Eye problems can happen if ESKATATM (hydrogen peroxide) topical solution, 40% (w/w) gets into your eyes, including: ulcers or small holes in your eyes, scarring, redness, irritation, eyelid swelling, severe eye pain, and permanent eye injury, including blindness.
If ESKATA accidentally gets into your eyes, your healthcare provider will tell you to flush them well with water for 15 to 30 minutes. Your healthcare provider may send you to another healthcare provider if needed.
Local skin reactions. Skin reactions have happened in and around the treatment area after application of ESKATA. Severe skin reactions can include: breakdown of the outer layer of the skin (erosion), ulcers, blisters and scarring. Tell your healthcare provider if you have any skin reactions during treatment with ESKATA.
The most common side effects of ESKATA include: itching, stinging, crusting, swelling, redness and scaling.
Your healthcare provider will not apply another treatment of ESKATA if your treated area is still irritated from the previous treatment.
Tell your healthcare provider right away if ESKATA gets into your eyes, mouth or nose during application. ESKATA is for topical use on the skin only, and is not for use in your eyes, mouth or vagina.
These are not all the possible side effects of ESKATA.
Approved Use for ESKATA
ESKATA is a prescription medicine used to treat seborrheic keratoses that are raised.
ESKATA is for use as an in-office treatment. ESKATA is applied by your healthcare provider and is not for use at home.
You are encouraged to report negative side effects of prescription drugs to the FDA. Contact Aclaris Therapeutics, Inc. at 1-833-ACLARIS or 1-833-225-2747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.