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[IP] Press release from another server



ISTA Pharmaceuticals Announces Clinical Trial Results of Vitrase For the 
Treatment of Diabetic Retinopathy

PR Newswire  January 7, 2002

ISTA Pharmaceuticals Announces Clinical Trial Results of Vitrase For the 
Treatment of Diabetic Retinopathy

ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced the results of a 
pilot Phase IIa study of Vitrase(R), a drug being developed by the Company 
for the treatment of patients with diabetic retinopathy.  Diabetic 
retinopathy is the leading cause of adult blindness in the United States and 
affects approximately four to six million Americans.
    Sixty patients in Mexico City who were diagnosed with non-proliferative 
diabetic retinopathy were enrolled in a prospective, randomized, 
placebo-controlled Phase IIa study.  The study's primary purpose was to 
evaluate the safety and efficacy of Vitrase in inducing a posterior vitreous 
detachment (PVD).  A PVD is the separation of the vitreous humor (the clear, 
gel-like substance that fills the back of the eye) from the retina, and may, 
according to retinal specialists, be
beneficial in the early treatment of diabetic retinopathy by delaying the 
progression of the disease.  A secondary endpoint was the determination of 
Vitrase's impact on slowing the progression of diabetic retinopathy over a 
one-year period.
    Interim study results at 16 weeks post-treatment, presented at the 
American Academy of Ophthalmology Meeting in late 2000, demonstrated that 
complete PVDs were documented in 60 percent of eyes treated with a single 
dose of Vitrase.  This is compared with only 6 percent of patients in the 
saline control group.  In the study's two additional treatment groups, 
complete PVDs were documented in 53 percent of eyes treated with 
sulfur-hexafluoride (SF6), a gas that is used as a surgical adjunct in the 
treatment of retinal detachment, and in 50 percent of eyes treated with a 
combination of Vitrase and SF6 gas.
    In order to assess and measure the progression of diabetic retinopathy 
for study patients, seven field fundus photographs (photographs of the 
retina) were taken at approximately 16 weeks following study entry and 12 
months later.  The fundus photographs were reviewed in a masked fashion by an 
independent reading center to determine an ETDRS (Early Treatment for 
Diabetic Retinopathy Study) retinopathy severity scale score assigned for 
each patient's study eye.
These ETDRS retinopathy severity scores were then evaluated to identify any 
changes in the patients' diabetic retinopathy over the one-year evaluation 
period.  Of the study's 60 patients, complete sets of fundus photographs were 
available, analyzed and scored for 46 patients.  Although the study was not 
designed to demonstrate statistical significance for progression of diabetic 
retinopathy among study groups, evaluation of ETDRS retinopathy severity 
scores did highlight
encouraging trends for slowing the progress of diabetic retinopathy.  Of the 
46 patients with fundus photographs that were analyzed and scored, 67% of 
patients treated with Vitrase (10 of 15) had stable ETDRS scores, ndicating 
no measurable progression of diabetic retinopathy over the one-year 
evaluation period.  This compares to stable ETDRS scores for the one-year 
evaluation period of 38% of patients treated with saline (6 of 16); 40% of 
patients treated with SF6 gas (6 of
15) and 43% of patients treated with Vitrase plus SF6 gas (6 of 14).  
Worsening of ETDRS scores, indicating a progression of diabetic retinopathy 
over the one-year evaluation period was seen in 13% of patients treated with 
Vitrase (2 of 15); 38% of patients treated with saline (6 of 16); 20% of 
patients treated with SF6 gas (3 of 15); and 21% of patients treated with 
Vitrase plus SF6 gas (3 of 14).
    Additionally, patients were also assessed to determine if the occurrence 
of a PVD on or before week 16 had any effect on the progression of diabetic 
retinopathy over the following one-year period.  For those patients who had a 
complete PVD on or prior to week 16, 50% treated with Vitrase (6 of 12) had 
stable ETDRS scores over the one-year period, as compared to 0% of those 
treated with saline (0 of 14); 30% of those treated with SF6 gas (3 of 10); 
and 40% of those treated with Vitrase plus SF6 gas (4 of 10).    Results for 
the one-year study indicated that adverse events were similar in type and 
frequency across all groups with reduced visual acuity the most frequently 
noted adverse event.
    "The study results suggest that Vitrase induced a physiological change 
that may be beneficial to the eye," stated Baruch Kuppermann, MD, PhD, 
Professor of Ophthalmology at the University of California, Irvine, one of 
ISTA's principal Vitrase investigators.  "Although this pilot study was not 
designed to demonstrate statistical evidence of efficacy in delaying the 
progression of diabetic retinopathy among study groups, the results support 
further clinical study to evaluate a potential role for Vitrase in the early 
treatment of diabetic retinopathy."
    Diabetic retinopathy is a complication of diabetes that impairs eyesight. 
Patients who participated in this study included only those patients who were 
diagnosed with the less dangerous, non-proliferative form of diabetic 
retinopathy. This disease is progressive and over time enters a more 
dangerous, or "proliferative," phase.  The proliferative phase of the disease 
is characterized by the growth of abnormal blood vessels on the surface of 
the retina and into the adjoining vitreous, which may leak and cause a 
hemorrhage within the eye.  There is no cure for diabetic retinopathy.  
Treatment today typically is limited to the
use of laser surgery at the proliferative stage of the disease. 
    ISTA Pharmaceuticals, based in Irvine, Calif., is focused on saving and 
improving eyesight by developing proprietary therapeutic products using the 
unique properties of the enzyme hyaluronidase.  ISTA's product candidates and 
programs address serious diseases and conditions of the eye such as vitreous 
hemorrhage, diabetic retinopathy, corneal opacification and keratoconus. 
Except for historical information contained herein, this press release 
contains "forward looking statements," such as statements regarding plans to 
pursue future clinical development of Vitrase for diabetic retinopathy and 
the potential benefit of Vitrase for the treatment of diabetic retinopathy.  
These statements are based on current expectations of future events and, as 
such, involve risks and
uncertainties which may cause results to differ materially from those set 
forth in such statements. 
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