RetinaPharma Announces FDA Clearance of Innovative Device to More Effectively Diagnose Glaucoma


-- TonoPach(TM) Technology Enables Improved Early Diagnosis of This Major Form of Preventable Blindness -- JENKINTOWN, Pa., Jan. 6 /PRNewswire/ -- RetinaPharma Technologies, Inc.today announced U.S. Food and Drug Administration (FDA) clearance to marketits proprietary TonoPach(TM) that enables more accurate diagnosis of glaucomaand ocular hypertension, leading causes of preventable blindness among adults.TonoPach is the first device to enable simultaneous determination ofintraocular pressure (IOP) and corneal thickness, increasing the accuracy andpredictive power of the IOP measurement that is traditionally used alone. Inaddition, thinned corneas, which can result from laser vision correctivesurgery as well as disease, can alter the IOP reading and mask underlyingglaucoma. With TonoPach, ophthalmologists can obtain better measurementsusing a low cost, easy-to-use solution to facilitate the correct diagnosis andtreatment of patients at risk of these disabling conditions. Glaucoma and ocular hypertension are leading causes of irreversibleblindness and impaired vision in the industrialized world, with over 7.5million individuals afflicted in the U.S. alone. Over 130,000 Americans arelegally blind as a result of this disorder. The growing prevalence of laservision correction surgery, estimated at one million patients each year in theU.S., increases the importance of accounting for corneal thickness when usingIOP measurements to diagnose glaucoma. "The FDA clearance of our device is an important milestone for our companyand for the millions of people at risk for glaucoma," said Terry A. Fuller,Ph.D., CEO of RetinaPharma. "The TonoPach is designed to be used in a manneridentical to existing instruments that measure intraocular pressure alone andis priced to maximize its accessibility to eye care professionals." Elevated IOP is the key parameter used to diagnose the risk of glaucomaand ocular hypertension. But in 2002, the National Eye Institute (NEI)published a large, randomized five-year study that showed that cornealthickness is an important risk assessment parameter for glaucoma anddemonstrated that when corneal thickness is combined with IOP, the combinedmeasure predicts the likelihood of damage to the patient's vision in a highlysignificant way. By allowing ophthalmologists to correct the observed IOPbased on measured corneal thickness at the exact point of IOP measurement, theTonoPach enables eye care professionals to simply, easily and accuratelyidentify patients who should be treated to manage their glaucoma or ocularhypertension and minimize any vision loss. "The leadership provided by Dr. Fuller and his team is an example of whatcan be achieved by fulfilling an unmet medical need with technical innovationand business leadership," said Barbara Schilberg, CEO of BioAdvance, theBiotechnology Greenhouse of Southeastern Pennsylvania. "This represents thefirst new product approval among our Greenhouse Fund recipients, and we arevery pleased to see RetinaPharma advance this important new device to market." RetinaPharma was a 2003 recipient of the BioAdvance Greenhouse Fund, whichprovides seed stage funding for promising life sciences companies.RetinaPharma, founded in 1998 and located in Jenkintown, PA, is a privatelyheld biotechnology company developing novel pharmaceuticals and relatedproducts focusing on the prevention, treatment, rescue, and recovery ofophthalmic and other neurodegenerative and neurovascular disease. Products indevelopment include the PhotoTarget(TM) System for treatment of 'wet' AMD andApoGuard(TM) for treatment of various neurodegenerative diseases.RetinaPharma's lead financing is from Hopkins Capital Group, LLC, a leadingprivate equity/venture capital investor and developer of disruptivetechnologies in healthcare. RetinaPharma can be reached at (215) 885-4558 of by e-mail atRelease@RetinaPharma.com