Uveitis

July 10, 2017

Galapagos announced a new phase II study investigating filgotinib in non-infectious uveitis, being led by filgotinib collaboration partner Gilead Sciences. The phase II study will be a multi-center, randomized, double-masked, placebo-controlled study to assess the safety and efficacy of filgotinib in adult patients with active, non-infectious uveitis. Approximately 110 patients are planned to be randomized in the study to receive filgotinib or placebo administered for 52 weeks. The primary goal is to evaluate the efficacy and safety of filgotinib versus placebo for the treatment of non-infectious intermediate-, posterior- or pan-uveitis. The primary outcome is measured by the proportion of subjects failing treatment by week 24; treatment failure is representative of an active uveitis flare. Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. This study is an addition to the ongoing phase II studies in cutaneous lupus erythematosus, Sjögren’s syndrome, ankylosing spondylitis and psoriatic arthritis, as well as the ongoing phase III program in rheumatoid arthritis, the phase III study in Crohn’s disease (also phase II in small bowel and fistulizing Crohn’s disease), and phase IIb/III study in ulcerative colitis.

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).

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