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news.EyeGate Pharma, a privately held pharmaceutical company that develops a non-invasive ocular drug delivery platform and ocular therapeutics, has completed a Phase II study of EGP-437, used for the treatment of anterior uveitis.
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Uveitis is an inflammatory condition of the internal structures of the eye that can lead to cataract, glaucoma, scarring, pain, photophobia, and even permanent loss of vision when undiagnosed or treated poorly. Uveitis is a leading cause of blindness and is estimated to occur in 102 of every 100,000 adults in the US per year.
The subjects, to be enrolled in this randomized double-masked study, were required to have non-infectious anterior segment uveitis with a cell score of more than 1.5 on a 0 – 5 scale, with 5 being worst and 0 being best. Enrolled subjects were given a single dose of EGP-437 (a dexamethasone derived corticosteroid solution) delivered at one of four dose levels using the EyeGate II Ocular Drug Delivery System, and were observed for 28 days.
EyeGate Pharma claimed that, after the single EGP-437 treatment, around half of the subjects achieved an anterior cell score of zero within two weeks, and by day 28, the majority of patients achieved cell scores of zero and required no further treatment. No significant changes in intraocular pressure or signs of cataract formation were detected. Data from the study will be presented at the Association for Research in Vision and Ophthalmology annual meeting in Fort Lauderdale on May 06, 2010.
Victor Perez, associate professor of Ophthalmology at the Bascom Palmer Eye Institute and one of the study investigators, said: “For uveitis patients, there is an unmet medical need, and doctors need a more predictable, effective treatment for severe uveitis. The EGP-437 Phase II data is encouraging because it not only shows promising signs of efficacy but addresses compliance issues, by providing the doctor direct control of the dosing. These results suggest that the EyeGate delivery system could lead to a more predictable clinical response in treating severe uveitis.”
EyeGate Pharma submitted the anterior uveitis study results and data from a completed Phase II study in dry eye patients to the FDA as part of an end-of-Phase II meeting. The company intends to initiate a multi-center Phase III study in dry eye patients, In the second quarter of 2010.
Stephen From, president and CEO of EyeGate Pharma, said: “We are pleased that EyeGate has successfully completed two Phase II studies, one for dry eye and one for anterior uveitis, using our iontophoresis technology to deliver EGP-437. These positive results help demonstrate that iontophoretically delivered drugs may offer Ophthalmologists new treatment options for patients.”