January 07, 2005

FDA Approves Device for the Diagnosis and Management of Glaucoma in LASIK Patients

RetinaPharma announces FDA-clearance of TonoPach device for glaucoma determination:  new  technology especially important for diagnosis and management of glaucoma in LASIK patients

RetinaPharma, a privately-held portfolio company of the Hopkins Capital Group, LLC, announced today that it has received 510(k) FDA clearance to market its unique, patented device that enables more accurate intra-ocular pressure (IOP) determination in patients. The device, TonoPach (TM), provides for the unprecedented simultaneous determination of intra-ocular pressure and corneal thickness at the same location on the cornea. This allows for ophthalmologist to make an adjustment of the intra-ocular pressure to take into account the affects of corneal thickness. The device was originally patented by Francis E. O'Donnell, Jr., MD, Managing Director of Hopkins Capital Group, LLC and Chairman of the Board of RetinaPharma and subsequently improved by Dr. Terry Fuller, Co-founder and CEO of RetinaPharma.

A large randomized, five-year National Eye Institute (NEI) study published in mid-2002 showed that patients' corneal thickness is the single most important biometric parameter in risk assessment for patients with glaucoma or ocular hypertension. The NEI study showed a highly significant correlation of corneal thickness that combined with IOP measurement predicts the likelihood of damage to the visual field. The TonoPach is the first instrument to concurrently measure both biometrics (IOP and corneal thickness) and offer it as a low cost, easy to use solution to patient management. The TonoPach is used in a manner identical to existing instruments for measuring intraocular pressure. However, its use during routine eye examination can easily and inexpensively provide meaningful additional data that is designed to help obtain correct diagnosis and ensure optimum patient management.

Glaucoma and ocular hypertension are leading causes of irreversible blindness and impaired vision in the industrialized world, with over 7.5 million individuals afflicted in the US alone. Over 130,000 people are legally blind as a result of this disorder in the US. In addition, there are an estimated 1 million patients receiving LASIK each year in the US.

The ability of the TonoPach to more accurately measure real IOP in patient's with thinned corneas is of particular concern in patient's whose corneas have been thinned as a result of excimer laser refractive surgery such as LASIK. There are an estimated 1M patients receiving LASIK each year in the US. Heretofore, such patients were known to have artifactitiously low IOP measurements which could mask elevated IOP and the risk of glaucomatous visual field loss. The TonoPach device allows for correction by the ophthalmologist of the observed IOP based on measured corneal thickness at the exact point of IOP measurement.

About RetinaPharma:

RetinaPharma is a privately-held biotechnology company developing advanced technologies for blinding retinal diseases such as glaucoma, macular degeneration, and retinitis pigmentosa. RetinaPharma was a 2003 recipient of the BioAdvance Greenhouse Fund. BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania finds and funds early-stage life sciences projects with promising products and devices. RetinaPharma's lead financing has been done by Hopkins Capital Group, LLC, a leading private equity/venture capital and business development firm committed to long-term patient capital for disruptive healthcare technologies.

The Company has exclusively licensed the PhotoTarget(TM) delivery technology from the Wilmer Ophthalmological Institute, The Johns Hopkins University Medical Institution. For the first time, this patented non-invasive technology allows for the precise delivery of pharmaceuticals to areas of diseased retina. The technology is well-suited to delivery of anti-angiogenics and photo-dynamic therapies for the wet form of macular degeneration. In the case of delivery of anti-angiogenics, it eliminates the need for intravitreal injection by needle insertion into the eye.

The Company has exclusively licensed the ApoGuard(TM) patented anti-apoptotic therapy from the University of Toronto. This active metabolite of an extremely safe anti-Parkinson's approved therapeutic, deprenyl, is being developed as a chemopreventative for a range of neurodegenerative diseases, including the dry form of macular degeneration.

About Hopkins Capital Group, LLC

The Hopkins Capital Group, LLC is a leading private equity/venture capital investor and developer of disruptive technologies in healthcare. The HCG provides long-term, patient capital for the commercialization of technologies that address significant unmet clinical needs. The Hopkins Capital Group, LLC is not affiliated with the Johns Hopkins University. For more information on the Hopkins Capital Group, LLC please visit the website at http://www.hopkinscap.com

CONTACT: RetinaPharma, Jenkintown Dr. Terry Fuller, 215-885-4558 tafuller@RetinaPharma.com Posted by Admin at January 7, 2005 04:50 PM