Refocus Group, Inc.

PresVIEW™ and Glaucoma - For Professionals

Refocus Group's Mission is to Become a Surgical Standard of Care for the Treatment of Glaucoma Worldwide

Note: The company’s primary product, the PresVIEW™ Scleral Implant  is an investigational device and is not approved for sale or use in the United States or Canada. However, the product is currently approved for sale in the European Union.

Ocular Hypertension and Primary Open Angle Glaucoma — Serious Medical Conditions

Ocular hypertension and glaucoma are medical conditions that typically show an elevated pressure within the eye. Ocular hypertension is characterized by high fluid pressure and is primarily associated with the inability of the eye to properly drain itself of fluids that constantly circulate into and out of the eye to provide nourishment. The fluid, known as aqueous humor, is produced by the ciliary processes and drains at the edge of the iris and cornea through the trabecular meshwork. In some patients, this elevated pressure may lead to glaucoma.

Glaucoma impacts the optic nerve in the back of the eye by damaging the nerve fibers that carry the information from the retina to the brain.  The nerve fibers are slowly destroyed in a gradual sequence or pattern resulting in peripheral vision loss that is not noticeable by the affected individual.  Over time, this visual field loss progresses to tunnel vision and then blindness.



In order to prevent this vision damage, especially if glaucoma has been diagnosed, abnormally high levels of intraocular pressure are often first treated with topical medications, and then with laser applications.

Typically these procedures will be followed with a surgical drainage procedure, and/or a surgical implant.  Unfortunately, even taken together, in many cases these treatments will only slow the progression of glaucoma, ultimately resulting in the loss of sight for the patient.



Moreover, many of these filtering techniques and glaucoma drainage devices (“GDD’s”), which open a direct path between the interior of the eye and the exterior environment in order to allow the aqueous humor to drain more rapidly, create their own set of complications and secondary conditions.   These complications are sometimes difficult to control and may result in accelerated advance of other serious medical problems, and eventual loss of sight.

Research by Refocus Group over many years suggests that some of the same factors that lead to presbyopia (the inability to see at near past the age of 45) are very likely factors contributing to elevated intra-ocular pressure (IOP) and eventually glaucoma in a certain people.



The company believes that as we age, presbyopia is caused in part by overcrowding of the muscles in the eye that change the shape of the lens, allowing the eye to focus at near.



Our research shows that these same muscles affect the ability of the eye to allow for the exiting of fluid (aqueous humor) through the trabecular meshwork.   In some individuals, when the muscles are no longer able to manipulate the crystalline lens, the ability of fluid to flow through the meshwork is also diminished, leading to increased pressure in the eye and possibly glaucoma.

Glaucoma is a serious condition and is one of the leading causes of blindness worldwide. According to estimates by the World Health Organization, there are 105 million suspected cases of glaucoma worldwide.

Refocus Group Pursues Ocular Hypertension And Primary Open Angle Glaucoma With An Innovative Treatment Option: The PresVIEW™ Scleral Spacing Procedure



Scientists and Clinicians at Refocus Group have developed a revolutionary new technique they believe will prove to be effective in treating primary open angle glaucoma and ocular hypertension. The company’s PresVIEW™ Scleral Spacing Procedure is being developed to re-establish the natural tissue spacing surrounding the crystalline lens — enabling the muscles of the eye to operate normally again, which in turn is intended to allow the natural stabilization of intraocular pressure by improving the flow of fluid through the trabecular meshwork.



In clinical trials performed in Canada in the year 2000, 24 glaucoma patients received the Scleral Spacing Procedure in an attempt to lower their intraocular pressure.  The group as a whole saw a mean decline in IOP of 7.1 mm Hg.

More importantly, it should be noted that all of these patients were on medications for their glaucoma prior to the SSP surgery, and after four years, more than 50% of these patients were off all medications.   Those remaining on medications saw a substantial decline in the amount required, usually declining by one or more medications from their starting point prior to the SSP surgery.



This minimally-invasive surgical procedure is designed to be completed by trained physicians on an outpatient basis in about 20-30 minutes per eye using topical and/or local anesthesia.  Because there are no compliance issues with the SSP Implants (versus medications whose usage is often inconsistent,especially with older patients) and because there is no decline in efficacy with the SSP omplants (versus medications whose potency will diminish between treatments in any 24 hour period), some surgeons may choose to use the SSP procedure before selecting medications.  Economically, the Company believes that the cost of the one time SSP Surgery will be more than offset by the high cost of monthly medications over a period of several years.



And unlike the use of medications and other more invasive surgical glaucoma devices and drainage procedures which will prohibit the subsequent use of the SSP procedure due to damage to the eye, the choice of the SSP implants before other treatments will not effect the surgeons ability to subsequently elect any or all of the other treatments, should the need arise.  Moreover, because it does not affect the cornea and the surgery occurs in the sclera (the white of the eye), the company believes the procedure is reversible.

Availability

In Canada, Refocus Group has completed a Phase I clinical trial for glaucoma under the monitoring of Health Canada and received approval from Health Canada for future clinical trials as part of the process required for eventual market approval in Canada.

 As of 2009, Refocus has several ongoing clinical trials in Europe (primarily Germany) for evaluating the efficacy of our surgery to treat glaucoma and ocular hypertension.