The new gel format aims to enhance ease of use for patients with inflammatory ophthalmic conditions.
ANI Pharmaceuticals (New Jersey, United States) announced that the U.S. Food and Drug Administration (FDA) has approved a prefilled syringe format for purified cortrophin gel (repository corticotropin injection USP).
The newly approved single-dose syringe will be available in 40 USP units/0.5 mL and 80 USP units/mL options, offering an alternative to the existing 5 mL and 1 mL vial presentations. The gel is indicated for a wide variety of inflammatory eye conditions, including allergic conjunctivitis, keratitis, uveitis, optic neuritis and more.
ANI Pharmaceuticals Announces FDA Approval on LinkedIn
Improved administration for patients
Nikhil Lalwani, president and chief executive officer of ANI Pharmaceuticals, stated: “Our new prefilled syringe reduces the steps required for patients to administer cortrophin gel treatment. We look forward to making the cortrophin gel prefilled syringe available in the second quarter of 2025 as we continue to advance our rare disease portfolio.”
What is cortrophin gel?
Cortrophin gel is an injectable medication containing naturally sourced, purified corticotropin, a protein complex that includes adrenocorticotropic hormone (ACTH).
ACTH helps stimulate the adrenal glands to produce corticosteroids, such as cortisol, which plays a critical role in immune system regulation and inflammation control. It also interacts with receptors in various organs, influencing inflammatory responses and other key functions throughout the body.
Cortrophin gel is administered subcutaneously or intramuscularly and is approved for treating ophthalmic inflammatory conditions, including severe allergic and inflammatory diseases affecting the eye, such as allergic conjunctivitis, keratitis, uveitis and optic neuritis. It is also indicated for select arthritic, autoimmune, allergic, skin, pulmonary, kidney and neurological disorders.
ANI Pharmaceuticals continues to expand its rare disease portfolio, aiming to make treatments more accessible and manageable for patients with complex conditions. The company says the prefilled syringe is just another step in simplifying administration and enhancing patient experience.
