Bangalore, Sep 7, 2006: Taiwan-based OculusGen Biomedical Inc.’s wholly owned subsidiary, Pro Top & Mediking Co. Ltd., has received the European Union’s CE Mark approval and the Canadian CMDCAS Certificate for OculusGen Biodegradable Collagen Matrix, the company's first product indicated for implantation in glaucoma, pterygium, and other selected ophthalmic surgeries.

 

The regulatory certifications signify that the product complies with all applicable safety and quality standards that allow the company to begin marketing and distributing the product in EU countries.

 

In addition, the CE Mark Approval is used to support market registrations in other regulated countries, including those within Asia, Latin America, and Eastern Europe. The company will submit the Canadian product license soon.

 

Mr Michael HJ Lai, President and CEO, OculusGen, expressed that this early approval represents a significant milestone for the company. He said the approval confirms that the results from OculusGen clinical trials have been both affirmative and positive.

 

Instead of using anti-fibrotic agents, the porous structure of OculusGen guides fibroblasts to grow randomly inside during wound healing process, which reduces the scar formation and avoids further inflammation. The super matrix may significantly increase the success rate by reducing intraocular fibrosis and avoiding mitomycin-C (MMC) induced complications. OculusGen improves the regenerating tissue remodeling and prevents scar formation and infection through bioengineering.

 

Mr Robert Ritch, MD, FACS, Chief of Glaucoma and Surgeon Director at The New York Eye and Ear Infirmary, stated that tissue bioengineering involves the combination of a polymer scaffold with a population of proliferating cells. He expressed that if the scaffold is biodegradable, it can result in the formation of structures, which are remarkably similar to the normal tissue. OculusGen provides the use of a scaffold and proliferating fibroblasts to create a planned bleb structure and potential future modification by growth factors and pharmacogenetics.

 

Trabeculectomy remains the current standard operation and the gold-standard surgical procedure for reduction of IOP after maximal medical treatment has failed, stated Mr Henry Shen-Lih Chen, MD, Glaucoma Specialist, Assistant Professor, Ophthalmology Dep, Taipei Chang Gung Memorial Hospital, Taiwan. The most critical factor of the final IOP after filtering surgery is the wound healing process. However, he said, the scar formation over the trabecular door and subconjunctival space is the most common cause of bleb failure.

 

The inventor of OculusGen, Dr Wei-Chen Hsu, MD, Assistant Professor, Ophthalmology Dep, Taipei Medical University Hospital, indicated that the application of OculusGen, a 3D collagen-glycosaminoglycan copolymer, can lead to a random reorganization of regenerating myofibroblasts, fibroblasts and the secreted extracellular matrix, resulting a reduction of scar formation. This matrix has an advantage over glaucoma drainage implants due to the fact that it is fully biodegradable after a certain period of time.

 

The 3D porous structure reduces intraocular pressure by producing a non-scarring physiologic regeneration of the extracellular matrix, and by providing a mature physiological aqueous reservoir system after glaucoma filtering surgery. The technique maintains a reasonably high success rate of trabeculectomy and reduces the complications of adjunctive antimetabolites or aqueous drainage devices.

 

OculusGen is more then glaucoma application. It has many potential applications in ophthalmology surgery. OculusGen has now been developed exclusively for the innovative LaserACE surgical procedure (AceVision Group, USA) to modulate the conjunctiva/scleral wound healing as an integral component of their dynamic accommodation surgery. LaserACE is currently under investigational study worldwide.