Vitreous Hemorrhage

September 12, 2005

ISTA Pharmaceuticals announced positive results of a pair of phase III trials of Vitrase (ovine hyaluronidase), for the treatment of vitreous hemorrhage, in the American Journal of Ophthalmology. Primary efficacy results achieved statistical significance for the lower dose group at 1, 2, and 3 months, with 13.2%, 25.5%, and 32.9% of patients, respectively, achieving clearance of hemorrhage sufficient to see the underlying pathology, vs. 5.5%, 16.2%, and 25.6% for placebo (p<0.001, p=0.002 and p=0.025). Safety data indicated that the drug was generally well tolerated, with iritis observed most often: overall incidence was 62.1%, 58.9%, and 62.1% for 7.5, 55, and 75 IU respectively, vs. 33.3% for placebo, and severe incidence was dose-related: 20.2%, 33.7%, and 39.7% vs. 8.9%. Retinal detachment occurred in 11.1%, 9.3%, and 11.5% of study eyes, vs. 6.9% for placebo. No differences were noted in incidence of cataracts. These randomized, double-blind, placebo-controlled studies evaluated a combined 1125 subjects for efficacy and 1362 for safety; subjects in the efficacy study received a single injection of one of 2 doses of the drug (55 IU or 75 IU) or placebo; a third cohort (7.5 IU) was added in the safety evaluation.

December 1, 2003

ISTA Pharmaceuticals reported positive results from two-phase III trials investigating Vitrase (ovine hyaluronidase) for the treatment of vitreous hemorrhage. Results demonstrated a statistically significant reduction in vitreous hemorrhage density as early as one month through three months after Vitrase injection compared to injection of saline solution. Treatment with Vitrase showed improvement in best-corrected visual acuity of three or more lines on an eye chart compared to saline solution. In addition, the density of the vitreous hemorrhages showed a significant decrease compared to placebo. The randomized, double-blind, placebo-controlled studies enrolled 1,306 subjects at sites worldwide. Results were reported at the Annual Meeting of the American Academy of Ophthalmology in Anaheim.

Miravant Medical Technologies reported positive results from two-phase III trials investigating SnET2, a photodynamic therapy for the treatment of wet age-related macular degeneration (AMD). Results showed that SnET2 (0.5mg /kg) stabilized visual acuity in a statistically significant number of subjects compared with placebo. Data showed that subjects who received three treatments over the first six months benefited most. The two randomized, placebo-controlled, parallel group studies enrolled a total of 920 subjects at 60 U.S. sites. Subjects received placebo or one of two drug doses tested. Visual acuity was measured using the Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart and compared to baseline. The results were reported at the American Academy of Ophthalmology in Anaheim.

April 1, 2002

Preliminary results of two phase III trials of Vitrase (hyaluronidase) did not show a statistically significant clearance of vitreous hemorrhage, the primary endpoint. However, statistically significant improvements in best-corrected visual acuity (BCVA) and vitreous hemorrhage density were demonstrated in both trials. A total of 1,306 subjects with severe vitreous hemorrhage whose visual acuity was worse than 20/200 were enrolled in the two randomized, double-masked, placebo-controlled international studies. In both trials, at one-month and two-month visits after a 55 IU Vitrase injection, statistically significant improvement in BCVA was observed. In one trial, this clinically relevant improvement extended to the three-month post-treatment visit for subjects receiving the 55 IU injection of Vitrase. In addition, significant decrease in vitreous hemorrhage density was seen at one, two, and three-month post-treatment visits. Vitrase is being developed by Ista Pharmaceuticals.

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