Biotech Values

[DonShimoda]

XOMA - Eyegate Pharma's pivotal Phase III study of EGP-437 in patients with anterior uveitis

* Note: This trial is focused on anterior uveitis which is distinct from XOMA's target of intermediate, posterior, or pan-uveitis.

EYEGATE PHARMA ENROLLS LAST PATIENT IN PIVOTAL
PHASE III ANTERIOR UVEITIS STUDY OF EGP-437

Waltham, MA – December 17, 2012 – EyeGate Pharma, a privately held specialty
pharmaceutical company developing a non-invasive ocular drug delivery platform and
ocular therapeutics, announces today that they have enrolled the last patient in the
pivotal Phase III study of EGP-437 in patients with anterior uveitis.
The study's objective is to evaluate the safety and efficacy of ocular iontophoresis with
dexamethasone phosphate ophthalmic solution (EGP-437) as compared to treatment
with topically applied prednisolone acetate (1%) ophthalmic suspension eyedrops. In
order to be enrolled into this multi-center randomized double-masked study, subjects
need to be between 12 - 85 years of age with a diagnosis of non-infectious anterior
uveitis, defined as an anterior chamber cell count of = 11 cells. About two hundred
patients were randomly assigned into one of two treatment arms in a 1:1 ratio. The
primary efficacy endpoint evaluates the proportion of patients with anterior chamber cell
count (ACC) of zero at Day 14. Safety will be assessed by the incidence and severity of
adverse effects (AEs), and measures of intraocular pressure and best-corrected visual
acuity. “Last Patient, Last Visit” is anticipated to be mid-February 2013. The company
expects to have top-line data in the early Spring of 2013.
A previous Phase I/II study demonstrated that a single EGP-437 treatment, administered
using iontophoresis, lowered ACC scores to zero (a complete response) in the majority
of patients, caused only minor AEs, and no non-ocular systemic corticosteroid mediated
side-effects were observed (Ophthalmology 119, 66 (2012)).
Principal study investigator Dr. John Sheppard of Virginia Eye Consultants said: “While
corticosteroids are widely used as treatments for ocular inflammation such as uveitis,
conventional 1% suspensions applied topically do not readily penetrate the intact ocular
surface; therefore, they require frequent dosing in order to achieve and maintain
adequate steroid levels. EyeGate's iontophoresis drug delivery approach has shown
promise in reducing anterior chamber cell scores in patients with uveitis after a single
treatment, suggesting that adequate levels of steroid are reaching the anterior segment of the eye.
http://www.eyegatepharma.com/pdf/news2012/EyegatePR_lastPatient_UveitisPH3_Final.pdf