Laser Eye Surgery and VISX - Part II: VISX and Laser Companies - History
Note: Part I of this summary can be found at
Message 11041441
VISX has been a leader in developing lasers for eye surgery. For the most part they have been first out of the gate with new developments and FDA approvals, and they have successfully accumulated and defended patent rights. However they were not the first excimer laser company to receive FDA approval. That honor went to Summit Technology for its Apex excimer laser system for the correction of mild to moderate myopia in 1995. A quick history of VISX follows.
VISX unveiled its STAR Excimer Laser System on March 6, 1995 in Hong Kong, and in the US later that same month.
Later that year, on September 26, 1995 VISX announced a license agreement with Chiron Vision, a subsidiary of Chiron, which included royalty payment to VISX and a worldwide license, excluding the United States, for use of the VISX patents by Chiron.
Shortly thereafter, on October 2, 1995 the FDA approved the marketing of the VISX excimer laser system. On October 6, 1995 VISX filed a registration statement for 2,500,000 shares of common stock to be offered by lead underwriter Dillon, Read & Co. That stock was sold on Nov. 8 at $23.75 per share. In the mean time the FDA's Ophthalmic Advisory Panel gave approvability to VISX's application to market and sell its STAR Excimer Laser Systems in the United States for the treatment of low myopia. This occurred on October 23, 1995 and full FDA approval was granted on March 28, 1996 allowing VISX Excimer Laser Systems to be used in the United States for the correction of mild to moderate myopia .
Further FDA approval came on April 24, 1997 when VISX became the first company to receive FDA approval for treatment of Astigmatism. This is part of the press release by VISX:
6/24/97
VISX Receives FDA Approval to Treat Myopic Astigmatism
Millions of Americans with Myopic Astigmatism Are Candidates for Laser Vision Correction
VISX, Incorporated has announced that the U.S. Food and Drug
Administration (FDA) has approved the VISX Star Excimer Laser System
for use in the treatment of low-to-moderate nearsightedness with
astigmatism, offering millions of Americans with astigmatism a new
alternative to eyeglasses, contact lenses and astigmatic keratotomy. The
approval allows eyecare practitioners to treat adults 21 years of age and
older with up to -6.0 D spherical myopia (spectacle plane) with -0.75 D to
-4.0 D astigmatism (spectacle plane).
Data from Bruce Jackson, MD, of the University of Ottawa Eye Institute
and Ottawa General Hospital, and a VISX clinical investigator, show that 98
percent of eyes treated with up to 6.0 D of spherical myopia and
concomitant astigmatism of up to 4.0 D attained 20/40 vision without
correction.
Note: Refractive errors are measured in diopters. The range is generally regarded as between +15 and 0 (hyperopic) and 0 and -25 (myopic), with the range +6 to -6 being by far the most common subset encompassing over 96% of patients.
Another patent agreement was reached on May 28, 1997, this time with LaserSight.
"VISX announced that it has entered into a patent license agreement with LaserSight Incorporated for the use of certain VISX patents for laser vision correction outside the United. In return for this license, LaserSight has agreed to pay royalties to VISX on the past and future sales of their laser vision correction systems worldwide, excluding the U.S."
On June 18, 1997 VISX announced that they had settled all outstanding U.S. and international patent disputes between themselves and Summit Technology, Inc. The settlement required a net payment of $4.5 million to Summit. A further settlement was announced on June 8, 1998. This time the competitors asserted that they had "resolved all differences between the two companies." The following is taken from a VISX press release:
"VISX and Summit have also
granted each other a worldwide, royalty free cross license. Each party will have full
rights to license their laser system users to all patents owned by either company
relating to laser ablation of corneal tissue including all patents presently included, or
includable, in Pillar Point. Under the settlement agreement, VISX has agreed to pay
Summit a total of $35 million."
The next milestone occurred on January 29, 1998, when VISX announced that the FDA
had approved the use of its excimer laser systems for the treatment of higher degrees of nearsightedness with astigmatism. VISX asserted at this point that greater than 99% of nearsighted consumers would now be eligible for laser vision correction procedures using VISX excimer laser systems. VISX thus became the first company in the U.S. to receive approval for the treatment of low, moderate and high myopia with astigmatism.
On March 24, 1998 VISX announced FDA approval of their newest model, the VISX STAR S2 Excimer Laser System, the unit that is in wide use today.
The next major approval was announced on NOVEMBER 3, 1998 when the FDA approved the use of the VISX STAR S2 Excimer Laser System for the treatment of from one to six diopters of farsightedness, with up to one diopter of astigmatism. VISX now became the first laser manufacturer in the United States whose systems were approved for the treatment of all three major refractive errors - myopia, astigmatism, and hyperopia.
That ends our quick history of VISX. Next I will take a very quick look at some of their competitors. These include Summit Technology, Autonomous Technologies Corporation, CHIRON Vision, LaserSight Incorporated, Bausch & Lomb and Nidek, Inc. CHIRON does not have US FDA approval and neither does LaserSight (Nasdaq: LASE) or Bausch & Lomb(BOL).- yet. Nidek is a privately held company based in Japan. They have been working on their Nidek EC-5000 Excimer Laser System since 1994. Near the end of 1998 their EC-5000 received FDA Approval for treatment of mild to moderate myopia in the United States (up to -13.0 diopters). Supplemental applications will be submitted in the near future, for correction of astigmatism up to 4.0 diopters. A clinical study for correction of hyperopia (farsightedness) is also underway. Unlike VISX, Nidek has not, and "does not intend" to, charge a per-procedure fee for their technology (VISX charges $250 per eye). VISX tried to obtain an injunction against NIDEK in the UK citing patent infringement. VISX was unsuccessful.
Late last year Summit (Nasdaq: BEAM) announced the now completed acquisition of Autonomous Technologies. Summit would appear to be the strongest competitor for VISX.
END PART II
A discussion of the LASIK procedure, financial information on VISX and some notes on competition from Summit will be presented in later parts.
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