Medical Device Daily
RetinaPharma Technologies (Jenkintown, Pennsylvania) reported that it received FDA clearance to market its TonoPach, designed to enable more accurate diagnosis of glaucoma and ocular hypertension, leading causes of preventable blindness among adults.
TonoPach, which is expected on be on the market by mid-2Q05, 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 with a new solution to facilitate the correct diagnosis and treatment of patients at risk of these disabling conditions.
RetinaPharma CEO Terry Fuller, PhD, told Medical Device Daily that the FDA clearance was “a nice New Year's present just before the end of the year.“
“The FDA clearance of our device is an important milestone for our company and for the millions of people at risk for glaucoma,“ said Fuller. “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.“
Glaucoma and ocular hypertension are leading causes of irreversible blindness and impaired vision in the industrialized world, with more than 7.5 million individuals afflicted in the U.S. alone. More than 130,000 Americans are legally blind as a result of this disorder. The growing prevalence of laser vision correction surgery, estimated at 1 million patients each year in the U.S., increases the importance of accounting for corneal thickness when using IOP measurements to diagnose glaucoma.
Elevated IOP is the key parameter used to diagnose the risk of glaucoma and ocular hypertension.
RetinaPharma was founded in 1998 and completed the development of the TonoPach in-house. Fuller said the company began the development in late 2000. However, the device was “originally conceived“ as a result of LASIK surgery creating thinner corneas, which masks the measurements normally taken to detect glaucoma.
“We didn't feel the market was large enough to launch that product,“ Fuller said.
But “serendipitously,“ the National Eye Institute (Bethesda, Maryland) reported results of a five-year study that “demonstrated that central corneal thickness along with measurements of intraocular pressure was the key biometric in predicting glaucoma or ocular hypertension,“ he said.
“All of a sudden we realized that the device we had developed [as a result of] LASIK had an even greater market potential for glaucoma and ocular hypertension, so our development efforts went into high gear basically in mid-2002,“ said Fuller.
After its initial filing with the FDA, the agency said it would require clinical data in order to give marketing clearance to the device. That prompted RetinaPhara to conduct a 250-patient study.
There are two “configurations“ of the device. One is a hand-held device and the other is designed to fit onto a slit lamp, which is used for eye examinations. The device provides “three bits of information“ to the ophthalmologist, Fuller said.
First, it provides a reading from applanation tonometry, which is currently done in ophthalmologist's office and is “gold standard“ way to measure intraocular pressure. It does this by exerting a tiny force onto the eye. But putting that force comes with the assumption that a patient's cornea has a standard thickness.
“It assumes that you do not have a thin cornea,“ which happens with LASIK surgery, Fuller said.
The TonoPach also provides pachymetry reading, which tells an opthalmologist the thickness of the cornea. But the most valuable information comes when he or she gets the “corrected applanation tonometry, which is the true intraocular pressure,“ Fuller said. And getting that reading cannot be accomplished easily without the TonoPach, he said.
RetinaPhara is planning to manufacture the product, but the company is “uncertain“ whether it will also do the marketing and distribution.
“We have decided from a corporate perspective that one way or another we are going to have the device available for sale [in the second quarter], but with this announcement, we are attempting to attract the attention of the major medical device companies, so that we might partner with them on marketing and distribution activity,“ Fuller said.
The target price for the device is in the range of $3,000 to $6,000, which is a big range, he said, but also in keeping with the price of existing devices.
“Our goal is to give the physician the ability to get more information to get the better diagnosis for the patient, but not at a premium cost,“ said Fuller.
In 2003, the company received $500,000 from the BioAdvance Greenhouse Fund (Philadelphia), which provides seed-stage funding for promising life science companies in southeastern Pennsylvania, making it the first company to receive such funding. With the FDA's action, it has become the first recipient of such money to secure FDA clearance of a product, Fuller said. RetinaPharma's lead financing is from Hopkins Capital Group, a private equity/venture capital investor and developer of technologies in healthcare.
“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.“