Posterior Uveitis

August 29, 2016

pSivida reported results of a phase III trial of Medidur in non-infectious uveitis. pSivida is conducting two phase III trials to assess the safety and efficacy of Medidur for the treatment of posterior uveitis. These are randomized, sham-controlled, double-masked trials. The primary endpoint of both trials is recurrence of posterior uveitis at six months, with patients in both trials followed for three years. The first phase III Medidur trial, which fully enrolled with 129 patients in 16 centers in the U.S. and 17 centers outside the U.S., met its primary efficacy endpoint, prevention of recurrence of disease at six months, with high statistical significance (p<0.00000001, intent to treat analysis) maintained through 12 months. The second trial, which will include up to 150 patients in approximately 15 centers in India, is currently being enrolled.

July 20, 2015

pSivida released results of a phase II study of Medidur for uveitis affecting the posterior of the eye. In the three-year, ongoing study, 11 participants with recurrent non-infectious intermediate, posterior or pan uveitis were randomized to receive a masked low or a high dose of Medidur. Eyes treated with Medidur experienced a significant improvement in visual acuity, gaining an average of 17 letters from baseline letters at 12 months on the Snellen eye chart (p=0.014 at 12 months). At the last followup visit reported, the average gain from baseline in Medidur-treated eyes was over 20 letters, while eyes treated with standard-of- care declined an average of 10 letters. Through the last follow-up visit reported, none of the eyes treated with Medidur had any recurrence of uveitis, while fellow eyes treated with standard-of-care averaged 2.33 recurrences. The most common adverse event in study eyes was elevated intraocular pressure (IOP). Through the last follow-up visit reported, three study eyes developed elevated IOP and were treated with eye drops, with filtering procedures subsequently performed in two of these eyes. However, those two eyes still gained an average of over 25 letters from baseline at the last observation. pSivida recently announced that at three months in its first phase III trial, which is testing only the low dose of Medidur, only 4% more study eyes (2/3 of which received Medidur) experienced elevated IOP than the fellow non-study eyes (none of which received Medidur).

March 30, 2009

Lux BioSciences released positive results from three phase III trials of LX211 for the treatment of uveitis. The three randomized, double-masked, dose-ranging and placebo-controlled trials comprised the LUMINATE Program and enrolled 558 subjects across several countries. The trials included LX211-01, which enrolled 218 subjects with active non-infectious uveitis with posterior manifestation of the disease, LX211-02 which enrolled 232 subjects with clinically inactive and LX211-03 which enrolled 108 subjects with active uveitis with anterior manifestation of the disease. Efficacy was measured at six months to assess the degree of inflammation, utilizing standardized scales for evaluation of inflammation in the anterior and posterior segments of the eye. In study LX211-01 a dose of 0.4 mg/kg twice daily fully met the primary endpoint of superiority to placebo at both weeks 16 (p≡0.008) and week 24 (p≡0.04) for mean change from baseline in vitreous haze, a measure of inflammation of the posterior segment of the eye. In study LX211-02 a dose of 0.4 mg/kg twice daily showed a reduction by 50% versus placebo in rate of recurrence of inflammation at six months (p≡0.046). In study LX211-03 the efficacy of the LX211 dose groups and placebo did not separate during the steroid taper; all showed an improvement by >1 step mean reduction from baseline in anterior chamber cells, a validated measure of inflammation in the anterior segment of the eye. LX211 was determined to be safe and well tolerated.

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