key biopharmaceuticals for vision

Investigational Drug From RetinaPharma May Facilitate Nerve Repair

PHILADELPHIA, Nov. 17-2003 PRNewswire

RetinaPharma Technologies, Inc. today announced results of a preclinical study that demonstrate its chemopreventative drug in development, desmethyldeprenyl (DES) has the potential to facilitate repair of damaged nerve cells. DES is a metabolite of the drug deprenyl used to treat Parkinson's disease, and in previous published studies RetinaPharma has shown it to have a protective effect in preventing nerve damage in organotypic cell culture.

This study demonstrates for the first time the potential for DES to go beyond neuronal protection to actually stimulate the repair of nerves after damage has occurred. The study was conducted under the direction of RetinaPharma's vice president of drug development William Tatton, M.D., Ph.D., a renowned expert in the mechanisms responsible for neuro-degeneration in a variety of conditions, and formerly professor, Departments of Neurology and Ophthalmology at Mount Sinai School of Medicine in New York and professor of Physiology and Psychiatry at the University of Toronto. The company is announcing these results Tuesday, November 18, at the Mid-Atlantic Venture Conference featuring BioVenture Forum East at the PennsylvaniaConvention Center in Philadelphia.

"What we consider so exciting about the results of this new study is that it demonstrates that under laboratory conditions, DES not only increases the capacity of damaged cells to re-grow axons, but the resulting axons also have the critical ability to connect with other cells," said Terry A. Fuller, Ph.D., president and CEO of RetinaPharma. "If confirmed in human trials, DES could have the potential to slow or halt disease progression and also to lead to some recovery of function in diseases in our area of specialization including glaucoma and age-related macular degeneration (AMD), as well as other degenerative diseases such as Parkinson's, amyotrophic lateral sclerosis (ALS) and Alzheimer's disease."

DES works by interrupting cellular signaling involved in apoptosis, or "programmed cell death", targeting a key enzyme (GADPH). DES selectively downregulates the cell signaling that results in apoptosis while preserving beneficial effects associated with GADPH. The study was conducted using organotypic cell cultures of both the retina and brainstem.

"Advances we are beginning to see from RetinaPharma and our other Greenhouse Fund recipients illustrate the clinical and commercial potential of emerging life sciences companies in our region," said Barbara Schilberg, managing director and CEO of BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania. "We are proud that our support is contributing to RetinaPharma, a recipient of our first round of investments." Data from this study have been accepted for publication in a peer-reviewed journal.

About RetinaPharma

RetinaPharma Technologies, Inc., a developer of unique pharmaceuticals directed toward the prevention, treatment and rescue of blinding neurodegenerative diseases, is initially focusing on applications of its deprenyl-related propargylamines including desmethyldeprenyl (DES) and its PhotoTarget(TM) drug delivery system for treatment of the leading causes of blindness including dry and wet age-related macular degeneration (AMD), glaucoma, retinitis pigmentosa, and Leber's optic neuropathy. The company is now expanding its activities to explore the potential of its developmental drugs in other degenerative nerve disorders, including Parkinson's disease, amyotrophic lateral sclerosis (ALS) and Alzheimer's disease.

About BioAdvance

As a key part of a $2 billion initiative by the Commonwealth of Pennsylvania to simultaneously support life sciences technologies and stimulate the economy, BioAdvance received $33.8 million from the State's share of the tobacco settlement monies to accelerate the creation of life sciences jobs and businesses in Southeastern Pennsylvania. BioAdvance will accomplish this goal through its principal funding program, the Greenhouse Fund, and other initiatives to link entrepreneurs to the region's wealth of resources. For information about BioAdvance, please visit www.bioadvance.com.

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FDA Clearance of Innovative Device to More Effectively Diagnose Glaucoma

TonoPach™ Technology Enables Improved Early Diagnosis of This Major Form of Preventable Blindness

Jenkintown, PA, January 6, 2004 – RetinaPharma Technologies, Inc. today announced U.S. Food and Drug Administration (FDA) clearance to market its proprietary TonoPach™ that enables more accurate diagnosis of glaucoma and ocular hypertension, leading causes of preventable blindness among adults. TonoPach is the first device to enable simultaneous determination of intraocular pressure (IOP) and corneal thickness, increasing the accuracy and predictive power of the IOP measurement that is traditionally used alone. In addition, thinned corneas, which can result from laser vision corrective surgery as well as disease, can alter the IOP reading and mask underlying glaucoma. With TonoPach, ophthalmologists can obtain better measurements using a low cost, easy-to-use solution to facilitate the correct diagnosis and treatment of patients at risk of these disabling conditions.

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 U.S. alone. Over 130,000 Americans are legally blind as a result of this disorder. The growing prevalence of laser vision correction surgery, estimated at one million patients each year in the U.S., increases the importance of accounting for corneal thickness when using IOP measurements to diagnose glaucoma.

“The FDA clearance of our device is an important milestone for our company and 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 manner identical to existing instruments that measure intraocular pressure alone and is priced to maximize its accessibility to eye care professionals.”

Elevated IOP is the key parameter used to diagnose the risk of glaucoma and ocular hypertension. But in 2002, the National Eye Institute (NEI) published a large, randomized five-year study that showed that corneal thickness is an important risk assessment parameter for glaucoma and demonstrated that when corneal thickness is combined with IOP, the combined measure predicts the likelihood of damage to the patient’s vision in a highly significant way. By allowing ophthalmologists to correct the observed IOP based on measured corneal thickness at the exact point of IOP measurement, the TonoPach enables eye care professionals to simply, easily and accurately identify patients who should be treated to manage their glaucoma or ocular hypertension and minimize any vision loss.

“The leadership provided by Dr. Fuller and his team is an example of what can be achieved by fulfilling an unmet medical need with technical innovation and business leadership,” said Barbara Schilberg, CEO of BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania. “This represents the first new product approval among our Greenhouse Fund recipients, and we are very pleased to see RetinaPharma advance this important new device to market.”

RetinaPharma was a 2003 recipient of the BioAdvance Greenhouse Fund, which provides seed stage funding for promising life sciences companies. RetinaPharma, founded in 1998 and located in Jenkintown PA, is a privately held biotechnology company developing novel pharmaceuticals and related products focusing on the prevention, treatment, rescue, and recovery of ophthalmic and other neurodegenerative and neurovascular disease. Products in development include the PhotoTarget™ System for treatment of ‘wet’ AMD and ApoGuard™ for treatment of various neurodegenerative diseases. RetinaPharma’s lead financing is from Hopkins Capital Group, LLC, a leading private equity/venture capital investor and developer of disruptive technologies in healthcare.

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RetinaPharma Announces FDA-Clearance of TonoPach Device for Glaucoma Determination

New Technology Especially Important for Diagnosis and Management of Glaucoma in LASIK Patients

St. Louis, Mo. : BUSINESS WIRE : January 7, 2004 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™ 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™ 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 JohnsHopkinsUniversity. For more information on the Hopkins Capital Group, LLC please visit the website at www.hopkinscap.com.

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