To date, the FDA has not approved any product for treating corneal graft rejection. Currently, EyeGate is enrolling two Phase II clinical studies utilizing EGP-437 in uveitis and dry eye patients. The results from these studies are expected in the first half of 2009.
The Phase II study in uveitis represents a proof-of-concept study of EGP-437 and the EyeGate II, the first-ever US clinical trial under an open investigational new drug to employ iontophoresis technology to deliver an active compound into the eye.
Michael Patane, chief scientific officer of EyeGate Pharma, said: For corneal graft recipients, a rejection episode can be a debilitating condition, and prompt diagnosis and treatment can halt the rejection process and enable the retention of a clear graft.
Given the imperative to intervene early and aggressively in this condition, and the requisite high frequency of dosing required to achieve therapeutic steroid levels in the anterior chamber, innovative methods that are capable of delivering more substantial steroid concentrations into the eye are of clinical interest and importance.