A Phase Ib/IIa clinical trial has reportedly treated the first macular edema patient with a novel delivery system designed to increase compliance and improve drug delivery to the posterior segment. The novel iontophoresis device is loaded with a specific formulation of dexamethasone phosphate and is placed on the patient’s eye following which electrical current facilitates transfer of the drug across a number of tissues. The technology is aimed at avoiding more invasive or injection based interventions which may often prove difficult for a proportion of patients. The delivery system, developed by a Massachusetts based company, Eyegate Pharmaceuticals, is undergoing an open-label, multli-center, Phase Ib/IIa trial to evaluate the safety and efficacy of iontophoretic dexamethasone phosphate ophthalmic solution in patients with macular edema.
According to the study’s sponsor, the technology originated at the Bascom Palmer Eye Institute, University of Miami, and has been employed in over 1,700 clinical treatments to-date, 1,000 of which are understood to have incorporated the novel dexamethasone phosphate therapeutic, “EGP-437”. The device uses a low-level electrical current to deliver a specified amount of drug via direct placment of the contact-lens like unit on the patient’s eye. The principle in use is that transport of the drug is powered by iontophoresis providing a non-invasive delivery method to circumvent a number of risks associated with both topical and invasive injection administration. The approach is additionally beneficial for patients intolerant of ocular injection and may also contribute to optimised patient and practice management by freeing up clinican time to more complex treatments. According to the device’s manufacturer, the iontophoresis treatment system can be administered by “a wider group of eye care practitioners” including optemtrists and nursing professionals.
In initiating the study, registered on clinicaltrials.gov, the experimatal design aims to detect a reduction in mean central subfield thickness evaluated by spectral domain optical coherence tomography (SD-OCT). In addition, changes in macular volume evaluated by SD-OCT will be recorded while a qualitative review of SD-OCT scans and dilated fundus exam will also be undertaken. Commenting on the clinical milestone, Richard Chace M.D., an investigator of the clinical trial stated, “the EyeGate(R) II Delivery System has the potential to change the way in which ocular drugs are administered, particularly those previously only available via injection. The first patient enrolled in the trial had previously undergone extensive treatment, including over a dozen intravitreal injections, and noted that the difference between iontophoresis and injection was remarkable. We look forward to following up with this patient as we assess the safety and efficacy of EGP-437 in ME, which could lead to the product’s evaluation in other posterior indications.”