ANI Pharmaceuticals Presents Preclinical Data on Purified Cortrophin® Gel in Autoimmune Uveitis Mouse Model

ANI Pharmaceuticals, Inc., headquartered in Princeton, N.J., revealed promising preclinical findings regarding Purified Cortrophin® Gel in treating experimental autoimmune uveitis (EAU) in a mouse model. These results were shared at the 2025 annual meeting of The Association for Research in Vision and Ophthalmology (ARVO) during a podium presentation. The study highlights the potential of Cortrophin Gel in reducing inflammation and preventing immune responses without adverse effects.

Dr. Mary Pao, Chief Medical Officer of Rare Disease at ANI, emphasized how these findings enhance the understanding of Cortrophin Gel's therapeutic mechanism. The study's premise involved using an experimental autoimmune uveitis mouse model to analyze the effects of four different doses (4, 40, 160, or 400 U/kg) of repository corticotrophin injection, equivalent to Cortrophin Gel. Results indicated a significant dose-dependent suppression of EAU, with the 400 U/kg dose showing the most effective suppression of the disease. Additionally, this dosage was effective in diminishing cytokine production associated with inflammation and immune system activation.

Cortrophin Gel was also found to protect against retinal damage caused by EAU, with effects comparable to α-MSH treatment when juxtaposed with a placebo. ANI Pharmaceuticals' President and CEO, Nikhil Lalwani, stated that the presentation at ARVO forms part of the company's ongoing dedication to bolster the scientific evidence and clinical data surrounding Cortrophin Gel’s mechanism and application.

The data was presented by Dr. Andrew W. Taylor, Sarkis J. Kechejian Professor and Associate Dean of Research at Boston University Chobanian & Avedisian School of Medicine. The presentation, titled "The Therapeutic Effects of Purified Cortrophin® Gel on Experimental Autoimmune Uveitis," was part of a session dedicated to innovative strategies for managing ocular inflammation.

Uveitis, an inflammatory condition affecting the eye's uvea, is addressed by Cortrophin Gel, which is administered either subcutaneously or intramuscularly. This prescription medication targets severe acute and chronic allergic and inflammatory conditions affecting the eye and its surrounding structures, including allergic conjunctivitis, keratitis, iritis, iridocyclitis, diffuse posterior uveitis, choroiditis, optic neuritis, chorioretinitis, and anterior segment inflammation.

However, there are significant safety considerations associated with Cortrophin Gel. It is contraindicated for intravenous use and should not be administered to patients with conditions such as scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, peptic ulcers, congestive heart failure, hypertension, certain adrenal gland disorders, or sensitivity to porcine proteins.

Warnings include the potential for increased susceptibility to infections, masking of chronic disease symptoms, psychiatric reactions, ophthalmic reactions like cataracts and glaucoma, risk of hypersensitivity, and effects on vaccination responses. The medication can exacerbate certain conditions, such as hypothyroidism, diabetes, or latent tuberculosis. It is crucial for healthcare providers to monitor growth and development in children under prolonged treatment and to apply caution in treating conditions like acute gouty arthritis.

Adverse effects commonly associated with Cortrophin Gel include fluid retention, muscle weakness, osteoporosis, peptic ulcers, injection site reactions, hypertension, convulsions, headaches, Cushingoid state development, and weight gain.

ANI Pharmaceuticals is committed to its mission of improving lives through the development, manufacturing, and commercialization of advanced therapeutics, focusing on rare diseases, generics, and brand-name pharmaceuticals.