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R.M. Lieberman, J.W. Chandler, B.D. Kuppermann, E.L. Thomas, L.R. Grillone; Vitrase® (Ovine Hyaluronidase), an investigational drug, for the treatment of vitreous hemorrhage: safety evaluation from two large Phase III studies . Invest. Ophthalmol. Vis. Sci. 2004;45(13):4116.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: Safety evaluation of Vitrase vs 0.9% saline. Methods: Patients with vitreous hemorrhage, >1 month; severe at entry & BCVA < 20/200; randomly assigned and received a single intravitreous injection (50 µL): saline (378), 7.5 (198), 55 (377) or 75 IU (391) Vitrase. Results: 742 patients were followed for >6 months and 535 were followed >1 year. Demographics and baseline characteristics among treatment groups were similar with a higher Hispanic representation in 7.5 IU. Between 72–88% of patients in saline and Vitrase groups had diabetes. Absolute difference in incidence of important ocular adverse events for 55 & 75 IU groups combined vs saline was highest for iritis (27%) and eye pain (17%). Difference for all other AEs was <10%, including hypopyon and retinal detachment. AEs statistically significant for all Vitrase groups included abnormal sensation in the eye, eye pain, iritis, increased lacrimation, hyperemia, photobia and photopsia. No AEs lead to study discontinuation. Most resolved by 30 days. Incidence of hypopyon was 3.5% (55 &75 IU); mean duration was 8 and 10 days, respectively. All hypopyon were considered sterile and related to test agent. The majority required medication. No hypopyon was reported for saline group. Iritis was of short duration: mean duration was 40 (saline), 31 (55 IU) and 27 (75 IU) days. Iritis requiring treatment: 41% (saline), 50% (55 IU) and 47% (75 IU). Mean duration of iritis requiring treatment was similar in all episodes and groups, whether treated or not. The majority of retinal detachments were judged unrelated to test agent. Incidence of recurrent hemorrhage and visual acuity reduction were statistically significant vs saline, but without a dose response. There were no cases of endophthalmitis. Conclusions: Safety of Vitrase is comparable to saline with the exception of iritis, hypopyon. Hypopyon were sterile, easily managed, and transient; iritis was easily managed and resolved quickly. Vitrase (55/75 IU) is safe for intravitreous injection.
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