Unilife, a medical device and technology company, has announced the signing of an agreement with a global pharmaceutical company seeking to use the Unilife Ocu-ject ocular drug delivery system to deliver a target injectable therapy into the eye.
The identity of the global pharmaceutical company, one of the market leaders in ophthalmic therapies, as well as other terms of the agreement are not disclosed for commercial purposes and due to confidentiality requirements. Unilife will begin to generate revenue under the program in January 2014.
Unilife's Ocu-ject platform offers a breakthrough technology for the accurate and precise delivery of small dose volumes measured in microliters (uL) into the eye. Most ocular therapies for the treatment of conditions such as age-related macular degeneration, diabetic retinopathy, and diabetic macular edema are administered via intravitreal injection using a standard 1mL tuberculin syringe and needle.
The potential for gross dosing inaccuracy is inherent with such conventional devices, which can compromise the ability of the drug to fully comply with its regulatory labeling requirements. Ocu-ject provides a tenfold improvement in the precision of delivering doses as small as 10uL, which helps pharmaceutical customers ensure compliance with dose requirements on the drug label.
Unilife chairman and CEO Alan Shortall noted in tune with the company's commitment to address unmet needs within the pharmaceutical industry, it has created a new, significant drug delivery device category.
"Ocu-ject represents a game-changing delivery technology for ocular therapies, which is a large, fast-growing segment of the pharmaceutical market. We are pleased to have signed our first agreement for the Ocu-ject device platform, which is being pursued by a number of pharmaceutical companies seeking to maximize the clinical and commercial potential of approved and pipeline drugs that are targeted to treat a number of eye disorders.
"We look forward to serving these customers to address unmet market needs for the accurate, precise delivery of drugs to the eye," Shortall added.
The Ocu-ject device platform is designed to deliver drugs with small dose volume of between 10uL and 500uL for delivery into the eye with a level of accuracy and precision not possible with conventional syringes. It is designed for use with injectable therapies designed to treat diseases including Age-related Macular Degeneration (AMD), Diabetic Retinopathy, Diabetic Macular Edema and Uveitis.
By minimizing over-dosing, the device platform has the potential to reduce the risk of increased intraocular pressure (IOP) and potentially minimize damage to the optic nerve. By further minimizing the risk of under-dosing, the platform has the potential to help avoid delivery of a drug outside its therapeutic window where its clinical efficacy may be compromised.
The Ocu-ject platform also employs the highest grade drug contact materials unlike syringes currently used to inject into the eye.
To address specific customer, drug, and patient requirements, products from the Ocu-ject platform can be customized in a variety of configurations including prefilled, with either an attachable or integrated retractable needle, or for use with a drug vial.
They are designed for intuitive use by clinicians, employ ergonomic features and have the potential to minimize patient pain and maximize safety.
