ANI Pharmaceuticals announces data on use of Cortrophin Gel

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Preclinical data on the use of Purified Cortrophin Gel (repository corticotropin injection USP) was recently announced by ANI Pharmaceuticals.¹

Cotrophin Gel is a prescription injection indicated for the treatment of severe acute and chronic allergic and inflammatory conditions affecting the eye and its adnexa – allergic conjunctivitis, keratitis, iritis and iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, and anterior segment inflammation.

“In a preclinical model of autoimmune uveitis, Cortrophin Gel reduced levels of inflammatory molecules without stimulating an adverse immune response,” said Mary Pao, MD, PhD, Chief Medical Officer of Rare Disease at ANI. “The results further support our understanding of Cortrophin Gel’s mechanism of action.”

An experimental autoimmune uveitis (EAU) mouse model was utilized to better understand the role of four doses (4, 40, 160, or 400 U/kg) of repository corticotrophin injection (RCI). RCI is an equivalent of Cortrophin Gel in the presented mouse model.

Results of the model showed significant dose-dependent effect on the suppression of EAU at all doses, with the greatest suppression of EAU at the highest, 400 U/kg dose. It was also found that a 400 U/kg dose of Purified Controphin Gel treatment suppressed retinal damage caused by EAU.

Andrew W. Taylor, PhD, presented the data at the Association for Research in Vision and Ophthalmology 2025 meeting held May 4-8 in in Salt Lake City. Taylor is the Sarkis J. Kechejian Professor; Associate Dean of Research; and Professor and Vice-Chair of Research, Department of Ophthalmology at Boston University Chobanian & Avedisian School of Medicine.

“The data presentation at ARVO is part of ANI’s broader commitment to clinical research for our products and, specific to Cortrophin Gel, we are committed to building on the scientific evidence and clinical data supporting its mechanism of action and clinical use,” said Nikhil Lalwani, President and Chief Executive Officer at ANI.

Reference:

1. ANI Pharmaceuticals, Inc. ANI Pharmaceuticals Announces Presentation of Preclinical Data on the Use of Purified Cortrophin® Gel in an Experimental Autoimmune Uveitis (EAU) Mouse Model. GlobeNewswire News Room. Published May 5, 2025. Accessed May 5, 2025. https://www.globenewswire.com/news-release/2025/05/05/3073925/0/en/ANI-Pharmaceuticals-Announces-Presentation-of-Preclinical-Data-on-the-Use-of-Purified-Cortrophin-Gel-in-an-Experimental-Autoimmune-Uveitis-EAU-Mouse-Model.html