research digest

Trial Results for Ecabet Sodium for Dry Eye Syndrome

ISTA Pharmaceuticals, Inc. has released the positive preliminary results from the randomized, three-arm, phase 2b clinical study of ecabet sodium, a prescription eye drop intended for the treatment of dry eye syndrome.

A total of 162 patients were enrolled in the trial and were randomly assigned to receive either placebo, or 3.0% or 3.9% ecabet sodium in the study eye q.i.d. for 90 days. Patients were evaluated for signs and symptoms four times during the trial, both prior to and following exposure to a controlled adverse environment ("dry eye chamber"). The study evaluated ocular signs, including corneal and conjunctival staining, tear film breakup time and blink rate; ocular symptoms, including burning or stinging, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness and blurriness.

The preliminary results of the study demonstrated a stronger trend in efficacy for the lower (3%) dose with respect to ecabet sodium's ability to address two objective signs of dry eye syndrome, corneal staining and blink rate. In addition, patients treated with the lower dose of ecabet sodium reported positive trends for reductions in symptomatology as measured by ocular surface disease index and most bothersome symptom. In the preliminary results, no efficacy trends vs. placebo were observed with respect to the higher (3.9%) dose. Further analyses of the phase 2b results are ongoing. A favorable safety profile was also suggested based on analysis of the study findings.

Vicente Anido, Jr., Ph.D., president and chief executive officer of ISTA says, "We are very encouraged by the preliminary findings, which show that ecabet sodium may be effective in addressing signs and symptoms of dry eye syndrome, a painful and debilitating eye disorder."

Glaucoma Worldwide in 2010 and 2020

A study published in the March 2006 issue of the British Journal of Ophthalmology estimated the number of people with open-angle glaucoma and angle-closure glaucoma in 2010 and 2020.

The study reviewed published data from population-based studies of age-specific prevalence of open-angle glaucoma and angle-closure glaucoma. The studies were used to construct prevalence models for open-angle glaucoma and angle-closure glaucoma by age, sex and ethnicity. The data was weighted proportional to the sample size of each study. Models were combined with the United Nations' world population projections for 2010 and 2020 to derive the estimated number with
glaucoma.

Investigators estimated that there will be 60.5 million people with open-angle glaucoma and angle-closure glaucoma in 2010, increasing to 79.6 million by 2020, and of these, 74% will have open-angle glaucoma. Women will comprise 55% of open-angle glaucoma, 70% of angle-closure glaucoma, and 59% of all glaucoma in 2010. Asians will represent 47% of those with glaucoma and 87% of those with angle-closure glaucoma. Bilateral blindness will be present in 4.5 million people with open-angle glaucoma and 3.9 million people with angle-closure glaucoma in 2010, rising to 5.9 and 5.3 million people in 2020, respectively.

Ophthalmology Management asked Harry Quigley, M.D., the Edward Maumenee Professor of Ophthalmology, director of Glaucoma Service and director of the Dana Center for Preventive Ophthalmology, to comment on the study. Dr. Quigley says, "The number of patients with glaucoma will increase dramatically, as the population of the world changes to include more elderly persons. Many of those with glaucoma, even in the developed world, are not diagnosed, and may lose vision needlessly unless more effective efforts to identify and treat them are begun."