Newsroom
FOR RELEASE Tuesday, May 3, 2005
FT. LAUDERDALE, FLA. - Today at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO), lead investigator Dr. Glenn J. Jaffe, professor of Ophthalmology, a vitreoretinal specialist and director of the Uveitis Service at Duke University Eye Center, Durham, N.C., presented the results of the analysis of two-year data from the Phase IIb/III randomized, dose-masked, multicenter clinical trial of Retisert (fluocinolone acetonide intravitreal implant) for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye.
In this trial, conducted at 26 centers in the United States and at one center in Singapore, 278 people with noninfectious uveitis of the posterior segment of the eye were randomized to receive either a 0.59 mg or a 2.1 mg implant in the affected eye, or in bilateral cases, in the more severely afflicted eye. The fellow eye was implant free.
Retisert is the world's first intravitreal drug product approved by the U.S. Food and Drug Administration for the treatment of this sight-threatening inflammatory condition. Retisert consists of a tiny drug reservoir designed to deliver sustained levels of the well-known corticosteroid fluocinolone acetonide directly to the back of the eye for approximately 30 months (two-and-a-half years). Bausch & Lomb is targeting mid-year availability of Retisert .
Efficacy Outcomes at Two Years
Recurrence Rate Reduced
Jaffe reported that at two years, there was a statistically significant lower
rate of disease recurrence (p<0.0001) in those eyes with Retisert
(11.2%) compared to the recurrence rate in the year prior to enrollment (59.7%)
and compared to the rate in the fellow eyes (50.0%) after two years.
Need for Adjunctive Therapy Decreased
A measure of the treatment's efficacy is a reduced need for adjunctive
treatments including systemic corticosteroid and/or immunosuppressive therapy,
periocular injections of steroids, and topical steroid therapy
(drops).
Jaffe reported that at two years, there were statistically significant decreases in systemic use of immunomodulatory therapy and in periocular corticosteroid injections post implantation (p=<0.0001).
The use of systemic steroid/immunosuppressive therapy declined from 52.5% of patients at enrollment to 12.5% two years post implantation. Similarly, the use of periocular injections of steroids declined from 68% of patients in the year prior to enrollment to 9.7% in the two years post implantation. In the fellow eyes, the use of the injections increased from 30.4% in the year prior to enrollment to 45.3% through two years, a statistically significant increase (p=<0.0001).
The use of topical steroid drops declined in the eyes with Retisert, from 35.7% at enrollment to 27.8% two years after implantation (p=0.05), while the use of the topical steroid drops increased in the fellow eyes from 25.3% at enrollment to 35.6% after two years (p=0.0008).
Visual Acuity Improved, Stabilized
Jaffe reported that visual acuity was stabilized or improved in the majority of
eyes with Retisert. In the eyes with Retisert, there was a
statistically significant improvement in visual acuity (p<0.0001) after two
years. Importantly, 24.3% of the study eyes had an improvement in vision of
three or more lines, compared to 5.3% of the fellow eyes.
Safety Outcomes at Two Years
Jaffe reported that at two years, the most common adverse events included cataract progression and increased intraocular pressure (IOP), which were anticipated given the nature of the disease and the type of drug used. These were well managed by conventional means including cataract surgery and the use of eye drops or filtering surgery to lower IOP.
At two years, in the phakic eyes (that is, eyes that have the natural lens) with Retisert, 89.4% had undergone cataract extraction compared to 13.3% of the fellow eyes.
At two years, eye drops for the control of elevated IOP were being used by 53.7% of the study eyes and 20.2% of the fellow eyes, compared to 14% of the study eyes and 10.9% of the fellow eyes at enrollment.
Jaffe reported that by two years, 30.6% of the implanted eyes required filtering surgery to control elevated IOP compared to 0.4% of the fellow eyes.
"The two-year data continue to demonstrate the strong efficacy and benefits of Retisert for people with this severe, blinding disease," said Jaffe.
Patients in the study will be followed for an additional year.
Bausch & Lomb is the eye health company, dedicated to perfecting vision and enhancing life for consumers around the world. Its core businesses include soft and rigid gas permeable contact lenses and lens care products, and ophthalmic surgical and pharmaceutical products. The Bausch & Lomb name is one of the best known and most respected healthcare brands in the world. Founded in 1853, the Company is headquartered in Rochester, New York. Bausch & Lomb's 2004 revenues were $2.2 billion; it employs approximately 12,400 people worldwide and its products are available in more than 100 countries. More information about the Company can be found on the Bausch & Lomb Web site at www.bausch.com . Copyright Bausch & Lomb Incorporated.
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