Corticosteroid drug delivery system may provide alternative treatment for anterior uveitis

The platform can assist with patient compliance and throughput, according to a presentation at the Ophthalmology Innovation Summit at AAO.

Issue: May 25, 2012

The EyeGate II platform is a noninvasive drug delivery system that has the ability to eliminate two major problems, compliance and patient throughput, when treating anterior uveitis, according to the president and CEO of EyeGate Pharma.

The active method of drug delivery is iontophoresis, which “works by promoting the migration of a charged drug substance across biological membranes by applying a low electrical current. The current produces ions, which via primarily electrorepulsion, drive a like-charged drug substance into the ocular tissues,” according to information filed by EyeGate Pharma with the U.S. Food and Drug Administration. Hence, drugs can be delivered through various tissues to the target areas, including the anterior and posterior tissues of the eye.

Standard of care

The current standard of care for treating anterior uveitis is aggressive topical steroids, but sometimes sub-Tenon’s injections are required, Stephen From, president and CEO of EyeGate Pharma, said at the Ophthalmology Innovation Summit in Orlando, Fla. preceding the annual meeting of the American Academy of Ophthalmology.

Early and aggressive intervention is important, he said. However, the problems with eye drops include low bioavailability and rapid clearance. Compliance with eye drops is also a challenge. A typical dosing regimen is eight treatments a day for the first week for a total of 56 treatments, followed by six treatments per day during week 2, and then 3 to 4 weeks of tapering.

“Overall, that is 196 treatments that we expect the patient to endure over a 4- to 6-week period,” Mr. From said.

Fewer treatments, more control

The EyeGate II platform requires only one treatment, and the ophthalmologist retains control. The device delivers EGP-437, which is a potent corticosteroid, Mr. From said. A uveitis study found that one 3-minute treatment was sufficient to achieve cell scores of zero by day 28, with no further therapy required, in the majority of patients.

“The EyeGate treatment delivers substantially more drug more quickly, which dramatically accelerates the onset of action,” Mr. From said. Moreover, there has been no detection of increased IOP in preclinical and clinical subjects.

The company also believes that EGP-437 is a suitable candidate for other ocular indications, including dye eye, scleritis, cataract surgery and corneal graft rejection.

In two dry eye studies, EGP-437 reduced signs and symptoms, and onset of action was within 24 hours. One of these studies involved 200 patients who had no change in IOP and no clinically significant slit-lamp findings, as well as significantly less staining in the inferior region of the cornea. Moreover, there was a significant reduction in conjunctival redness and other symptoms, notably burning sensation.

Patient throughput with intravitreal injection includes some “logistical gymnastics,” Mr. From said. The need for a dedicated room, staffing, room preparation, patient prep, treatment and observation can create challenges.

“The time alone takes more than 30 minutes,” Mr. From said. Plus, there is a limited number of ophthalmologists who do injections, and there is a constant stream of new products and indications.

“Because our device is noninvasive, a much larger group of ophthalmologists can actually do the procedure, without the safety risks associated with an intravitreal injection,” Mr. From said.

The prep and delivery time of the EyeGate treatment is about 8 minutes, and protein is delivered to the retina and vitreous. – by Bob Kronemyer

For more information:

Stephen From can be reached at EyeGate Pharma, 100 Beaver St., Waltham, MA 02453; 781-788-8869; email: sdfrom@eyegatepharma.com.
Disclosure: Mr. From is president and CEO of EyeGate Pharma.