Phase 1 Iontophoretic Delivery of Dexamethasone for Tx of Anterior Scleritis

Investigator: Nisha Acharya, MD
Sponsor: University of Pennsylvania

Location(s): United States


Non-infectious scleritis is an inflammatory disease of the eye wall (sclera). Its estimated US prevalence is 50,000. Scleritis typically is managed with oral non-steroidal inflammatory drugs, systemic corticosteroids, and/or systemic immunosuppressive drugs. In tertiary settings, most patients require long-term therapy, including systemic corticosteroids and/or immunosuppression. Even in the context of systemic disease, scleritis often drives the treatment regimen. For this high impact orphan disease, an effective locally administered treatment regimen that avoided systemic side effects would be very desirable.

Eyegate Pharma is developing an iontophor-etic delivery system to deliver dexamethasone phosphate ophthalmic solution (40 mg/mL) to the eye, targeting the indications of uveitis and dry eyes. Dexamethasone is a well-known corticosteroid, available in other formulations for ocular and systemic delivery for decades. We consider iontophoretic corticosteroid delivery as likely to be effective for treatment of scleritis, because it provides a means of delivering drug past the subconjunctival vascular plexus, which rapidly clears eyedrops. Available evidence suggesting that iontophoretically delivered dexamethasone may be effective for scleritis includes: effectiveness of systemic corticosteroids and depot corticosteroids placed adjacent to the sclera for scleritis, and partial effectiveness of corticosteroid eyedrops.