Technologies International, Inc. announced
that the U.S. Food and Drug Administration has approved the Company's
HYPERION(TM) LTK (Laser Thermal Keratoplasty) System.
The laser time for the SUNRISE LTK(TM) Procedure is three seconds
per eye and involves no cutting or removal of corneal eye tissue. The
HYPERION(TM) LTK System gently heats eye tissue outside the center of
the cornea, thereby causing it to steepen and reduce hyperopia
"The HYPERION LTK System, the first refractive laser procedure
designed specifically for farsightedness, is a breakthrough technology
that represents the latest available alternative for the estimated 60
million(1) farsighted individuals over the age of 40 within the United
States," said C. Russell Trenary III, President and CEO of Sunrise.
Farsightedness is the most common refractive error of the American
population, with about 77 million total farsighted individuals. An
independent research study known as The Baltimore Eye Study(1)
(conducted by investigators from Johns Hopkins University and
supported by grants from the National Institutes of Health), revealed
that the number of Americans over age 40 with hyperopia is nearly
twice as large as those with myopia. In fact, the Study projected that
by the Year 2000, there would be 118 million Americans over the age of
40 -- and about 60 million of them (or 52 percent) would be hyperopic.
About 62 percent, or approximately 40 million, of these hyperopes were
expected to be low to moderately farsighted in the range of +0.75 to
+2.50 diopters, the initial approved indication for use of the SUNRISE
Approval of the premarket approval application for the
HYPERION(TM) LTK Laser System is for the temporary reduction of
hyperopia in patients with +0.75 to +2.50 diopters of MRSE with less
than or equal to +/- 0.75 diopters of astigmatism, who are 40 years of
age or older with documented stability of refraction for the prior 6
months, as demonstrated by a change of less than or equal to 0.50D in
spherical and cylindrical components of the manifest refraction. The
magnitude of correction with this treatment diminishes over time, with
some patients retaining some or all of their refractive correction.
Ophthalmologists Sandra C. Belmont, M.D., F.A.C.S., and Brian S.
Boxer Wachler, M.D., who are both clinical investigators for Sunrise
Technologies, look forward to offering the SUNRISE LTK(TM)Procedure as
a new option for their farsighted patients.
"I believe that the SUNRISE LTK Procedure will become the
procedure of choice for farsightedness because of its excellent safety
profile, effectiveness, low learning curve for physicians, and ease of
treatment for the patient. As is the case with most doctors, I
understand that no single technology will treat all refractive
conditions. We needed a good, safe, quick procedure for farsighted
patients, and now we have it," said Dr. Belmont, who is Director of
the Laser Vision Correction Center and Corneal Service at New York
Weill Cornell Medical Center of New York Presbyterian Hospital in New
York City, where she is an Associate Professor of Clinical
"The SUNRISE LTK Procedure is the first technology that brings
refractive surgery to a comparable safety level of soft contact
lenses. LTK breaks through the 'fear factor' for patients considering
laser eye surgery," said Dr. Boxer Wachler, Director of the UCLA Laser
Refractive Center and Assistant Professor of Ophthalmology of the
Jules Stein Eye Institute at the UCLA Department of Ophthalmology in
How Sunrise LTK Procedure Works
The Sunrise LTK Procedure uses laser energy to gently reshape
the cornea without touching the eye. It differs from currently
available procedures because no scalpel incisions or laser ablations
are used to cut or remove corneal tissue, and it differs from
intracorneal ring and intraocular lens procedures because no objects
are inserted into the eye.
Instead, a holmium:YAG laser utilizing a patented process for
shrinking collagen applies two concentric rings of eight simultaneous
spots of laser energy to the periphery of the cornea (not the visually
important center of the cornea that you see through) to gently heat
the corneal collagen and steepen its shape, thereby improving its
refractive (focusing) power. Because no tissue is cut and the eye is
not touched by any instruments, the possibility of intra-operative
complications, postoperative infections, or risk of healing
irregularity that may affect vision is minimized.
In U.S. clinical trials of the SUNRISE LTK Procedure, patients
generally had improved vision immediately after the procedure, and
most people were able to return to work and resume their regular
activities the day after treatment. Topical anesthetic eye drops were
used prior to the procedure and patient complaints of post-operative
pain or discomfort were usually minimal, lasting about 24 hours or
less. When required, over-the-counter analgesics were prescribed, and
were typically discontinued within one to two days.
Sunrise Technologies International, Inc., is a Fremont company
that produces and markets high technology products revolutionizing
treatment methods in eye care. The Company develops Holmium
laser-based systems which utilize a patented process for shrinking
collagen developed by Dr. Bruce Sand (the "Sand Process") in
correcting ophthalmic conditions. These Systems incorporate a
non-contact simultaneous application for correction of hyperopia
(farsightedness), presbyopia (loss of focus due to natural aging), and
over-correction resulting from PRK and LASIK treatments for myopia.
The presbyopia and over-correction indications are currently under
clinical investigation in the U.S. The Sunrise LTK Procedure is
currently in use in Europe, South Africa, Canada, Central America and
(1)The Baltimore Eye Study, an independent study conducted by
investigators from Johns Hopkins University and supported by grants
from the National Institutes of Health, published in Investigative
Ophthalmology & Visual Science, February 1997.
Internet users can access Sunrise's World Wide Web site at www.sunrise-tech.com.