WALTHAM, MA -- (Marketwired) -- 04/09/13 -- EyeGate Pharma announces that the topline results from their Phase III study of EGP-437, a corticosteroid formulation, in Anterior Uveitis patients demonstrates that two iontophoretic treatments of EGP-437 achieved the same response rate as the positive control, prednisolone acetate 1% ophthalmic suspension administered as multiple daily eyedrops, the current standard of care.
In this randomized, double-masked placebo-controlled study conducted at 45 clinical sites in the USA, a total of 193 patients were randomly assigned into one of two treatment arms (iontophoretic treatment on days 0 and 7 or 14 days daily treatment of prednisolone acetate 1% ophthalmic solution, which was followed by two weeks of standard tapering) (http://clinicaltrials.gov/ct2/show/NCT01505088?term=EGP-437&rank=6). The primary efficacy endpoint is the proportion of patients with anterior chamber cell (ACC) count of zero on Day 14, which is defined as a complete response.
In all randomized subjects (the Intent to Treat Population), ONLY two iontophoretic treatments with EGP-437 (Days 0 and 7) resulted in 32 complete responses out of 96 patients on Day 14; and the standard-of-care uveitis treatment (daily treatment) -- prednisolone acetate 1% ophthalmic suspension also yielded 32 complete responses out of 97 patients who received multiple daily self-administered eye drops over the first 14 days (Days 1 - 7: eight drops per day and Days 8 - 14: six drops per day).
Regarding safety, the incidence and severity of treatment-emergent adverse events (TEAEs) in both groups were comparable and there were fewer incidences of elevated intraocular pressure (IOP) in the EGP-437 group.
"Inadequate compliance with aggressive eye drop regimens often leads to treatment failures," commented Dr. John Sheppard, the study's principal investigator. "Offering our uveitis patients a safe effective treatment option that is controlled by the healthcare provider rather than the patient represents an important breakthrough, especially when there is a history of poor compliance, difficulty with eye drop self-administration, elevated IOP, glaucoma, or preservative toxicity. Iontophoresis technology creates new paradigms for both ocular drug delivery and for uveitis management."
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)). Clinical and non-clinical studies utilizing iontophoretic delivery of EGP-437 have demonstrated the potential for reduced risk of corticosteroid side effects, notably elevated IOP.
"This is a major milestone for the Company and the ophthalmology sector as it further validates a unique new way to deliver therapeutics into the eye," said Stephen From, President and CEO of EyeGate Pharma. "Treating uveitis requires up to 16 eye drops per day over a period of 4 to 6 weeks, which is very inconvenient for the patient. A couple of treatments with our product produced the same results, which is much simpler and more reliable for the patient. Our team has invested several years into developing this delivery platform and continues to advance our understanding of its versatility beyond the use of corticosteroids, such as EGP-437, including the delivery of proteins to the back of the eye."
About Uveitis and Current Treatment Limitations
Uveitis is an inflammatory condition of the internal structures of the eye that can lead to cataracts, 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 inflict 102 of every 100,000 adults in the U.S. per year.
Depending on the severity, standard management of uveitis consists of corticosteroid treatment applied either topically (several times per day), by injection, systemically or by a combination thereof. The effectiveness of corticosteroid eye drops is often compromised due to poor patient compliance, inadequate dosing, or abrupt or rapid tapering schedules.
Ocular iontophoretic delivery (e.g. EyeGate® II Delivery System) of therapeutic agents has generated significant interest as a means of non-invasively achieving higher drug levels within the eye (by promoting the migration of a charged drug substance across biological membranes).
About EyeGate Pharma
EyeGate Pharma, a privately held specialty pharmaceutical company developing a non-invasive ocular drug delivery platform and ocular therapeutics designed to address two major issues in ophthalmic medicine, patient compliance and patient throughput. The EyeGate technology features a compact, elegant, and easy-to-use device that delivers drugs non-invasively and quickly into the ocular tissues, which can dramatically accelerate onset of action, reduce treatment frequency (vs eyedrops) and sustain therapeutic effect. The procedure only takes a few minutes and can be administered by all eye care practitioners. The EyeGate® II Delivery System is compatible with a wide range of therapeutics and has the potential to address many anterior and posterior segment diseases. Over 1,700 treatments have been performed with the EyeGate® II Delivery System. It is the first ocular iontophoresis system to have completed Phase II studies (Uveitis and Dry Eye) and Phase III studies (Uveitis and Dry Eye). For more information, please visit www.eyegatepharma.com.
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