The FDA has granted ANI Pharmaceuticals, Inc. approval for Purified Cortrophin Gel (repository corticotropin injection USP) in a prefilled syringe format (PFS).
The ophthalmic tie-in: Among its numerous indications, Cortrophin Gel is intended for treating severe acute and chronic allergic and inflammatory conditions impacting the eye and its adnexa (the area surrounding and supporting the eye but excluding the eyeball itself and optic nerve).
Let’s talk about ANI for a moment.
The integrated biopharmaceutical company specializes exclusively in developing, manufacturing, and marketing branded and generic prescription-based pharmaceutical products for rare diseases with unmet needs.
In (relatively) recent news: ANI made a major splash—and gained a major foothold—in the ophthalmic industry by purchasing Alimera Sciences, a global biopharmaceutical company.
Now about this product …
Purified Cortrophin Gel contains a naturally sourced, purified hormone known as corticotropin (comprising a complex mix of proteins).
- Among these proteins is ACTH (adrenocorticotropic hormone), which is reported to potentially reduce inflammation by increasing the body’s production of cortisol and, as a result, regulating the immune system to reduce inflammation.
In simpler terms: Cortrophin Gel is a prescription-based medication designed to be self-injected by a patient either subcutaneously or intramuscularly.
- Recommended injection sites: abdomen, upper thigh, or upper arm
And inside the actual formulation?
Per its prescription information (PI), the therapeutic is a sterile preparation of 80 USP units per mL with:
- 0.5% phenol (as a preservative)
- 15% gelatin (for prolonged activity)
- Water (for injection)
- pH adjusted with hydrochloric acid (HA) and sodium hydroxide (NaOH)
Zero in on those indications you mentioned.
While its non-ophthalmic indications include forms of arthritis, atopic dermatitis, acute flareups in multiple sclerosis, and severe psoriasis, it’s also indicated for inflammatory eye diseases such as:
- Allergic conjunctivitis
- Keratitis
- Iritis and iridocyclitis
- Diffuse posterior uveitis and choroiditis
- Optic neuritis
- Chorioretinitis
- Anterior segment inflammation
What kind of dosing schedule is advised?
According to its PI: As much as 80 units for a single injection or one or more injections of a lesser dosage can be used.
However: This is dependent on standard tests for verification of adrenal responsiveness to corticotropin performed prior to treatment—plus: the verification dosage should be individualized based on a patient’s needs.
- The PI also warns that “chronic administration of more than 40 units daily may be associated with uncontrollable adverse effects.”
Hold up a moment; wasn’t this already approved?
You’re probably thinking of Acthar Gel or Purified Cortrophin Gel (note the lack of “PFS”), which was first approved in 1954 and later reintroduced to the U.S. market by ANI in 2021.
- See its product website.
Ah, gotcha. So what’s the purpose of the new approval?
The pre-filled syringe option “reduces administration steps for patients using Cortrophin Gel, which remains available in 5 mL and 1 mL vials,” according to ANI.
- Comparatively: The PFS version will be available in 40 USP units/0.5 mL and 80 USP units/mL single-dose options
Any notable warnings or precautions to keep in mind?
Indeed. An increased susceptibility to infections; elevated blood pressure, salt, and water retention; psychiatric reaction; and an increase in hypersensitivity reactions after prolonged administration of the injection may arise among patients.
Looking specifically at ophthalmic reactions: Prolonged use could also “produce posterior subcapsular cataracts and glaucoma” as well as cause potential optic nerve damage.
- See here for the full rundown.
How about contraindications?
Cortrophin is contraindicated for intravenous administration as well as in patients with such conditions as congestive heart failure, hypertension, and ocular herpes simplex, to name a few.
And before you ask: A list of potential adverse reactions can be found here.
Duly noted. Last question: When and where will this be available?
When: Q2 2025.
Where: ANI reported the PFS will be accessible through Cortrophin Gel’s established specialty pharmacy network. Click here to learn more.