One in the eye for systemic therapy

TheraKine and Capsulution NanoScience are collaborating to develop new drug delivery systems to aid in the treatment of serious eye diseases.

TheraKine will make use of Capsulution's formulation expertise to help deliver both small molecule and complex biologic drugs directly to the eye using its biodegradable implant technology and minimise the discomfort suffered by patients during treatments.

Current treatment of inflammatory eye diseases such as uveitis, diabetic retinopathy and age related macular degeneration (AMD) often involves the systemic administration of steroids, immunosuppressants or biological drugs.

Because the drugs are administered systemically only traces of the compound reach the interior of the eye with high levels of the compound causing undesirable side effects in other parts of the body.

While intravitreal injections (injections into the eye) offer a solution to this problem, unpleasant repeated injections are required and have so far been limited to a small number of anti-VGEF (vascular endothelial growth factor) drugs and long lasting steroids.

Repeated intravitreal injections can lead to significant side effects such as internal bleeding, cataracts, retinal damage, increase of pressure inside the eye and infection.

TheraKine aims to use the Capsulution's controlled-release technology to enable combinations of small molecule and biological drug compounds from its biodegradable eye implants and minimise patient discomfort.

In addition, because the drugs will be delivered at the site where they are needed, the drug dosage should be reduced, a factor that is becoming increasingly important with the increasing use of complex biologic drugs that are often expensive to produce.

"TheraKine's mission is the creation of therapeutic systems to improve vision and prevent blindness," said Scott Hampton, CEO of TheraKine.

"Effective and safe treatments are desperately needed by millions of people who are currently suffering progressive vision loss due to chronic inflammatory and degenerative eye diseases. Our targeted local delivery will offer safety, effectiveness, and affordable treatment costs."

Hampton told in-PharmaTechnologist.com that the drug delivery implant systems will be small enough to be injected into the eye by physicians like any routine eye injection, avoiding the risks associated with surgical implantation.

The collaboration should enable water-soluble biological drugs to be incorporated into the implant in combination with water-insoluble anti-inflammatory compounds using Capsulution's unique layer-by-layer (LBL) nano- delivery capsules.

TheraKine's most advanced product, EpiKine, is a prophylactic topical drug formulation that will reduce complications and improve the outcomes of laser refractive surgery and improve corneal wound healing while decreasing scarring and infection.

EpiKine is being investigated in preclinical animal trials in association with the US Air Force and hopes it will enter human trials in 2009.

Details of the collaboration were undisclosed.