dm+d

28426008

New Medicines

Iluvien (EU); Durasert (US) Uveitis; posterior - second-line

Information

Iluvien (EU); Durasert (US)
Licence extension / variation
pSivida
pSivida

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Phase III Clinical Trials
Yes

Jan 18: Alimera announce EU MA application is accepted for review. Application seeks to add indication of recurrent and persistent non-infectious uveitis affecting the posterior segment (NIU-PS) [9].


Jul 17: pSivida has renegotiated an agreement with Alimera, and will now out-license fluocinolone acetonide micro-insert intravitreous implant to Alimera in the EU, Middle East and Africa for uveitis. Under the terms of the agreement, pSivida will withdraw its centralised application in the EU for posterior uveitis, and Alimera will be responsible for filing an application for a new indication for Iluvien for the treatment of posterior uveitis in the EU, where Iluvien is currently approved for the treatment of diabetic macular oedema. Alimera will file the new application within the next 8 months [8].


Jun 17: pSivida submit MA application to EMA [7].


Dec 16: Medidur name changed to Durasert [5]


Dec 15: pSivida plans to file for approval in mid-2017, with a launch in 2018 [3].


May 15: The company intends to file for US approval in the first half of 2017 [1].


Medidur is an injectable micro-insert designed that provides sustained release of flucinolone acetonide for three years. Medidur comprises the same micro-insert (same design, same polymers, same drug, same dose) as ILUVIEN for DMO [1].

Category

Fluorinated corticosteroid given once every 3 years.
In the US posterior Uveitis affects approx 175,000 pple, resulting in approximately 30,000 cases of blindness and making it the 3rd leading cause of blindness [1].
Uveitis; posterior - second-line
Intravitreal

Trial or other data

Oct 16: Pts are typically treated with systemic steroids but over time frequently develop side effects that limit effective dosing. Pts then often progress to steroid-sparing immune suppressants or biologics, which themselves can have severe side effects. Medidur is designed to provide improved outcomes compared to standard of care but with a significant reduction in side effects [1].


Oct 16: Enrolment (n=150) completed for the second PIII pivotal trial designed to assess the efficacy of fluocinolone acetonide intravitreal inserts in patients with uveitis, in India (PSV-FAI005; NCT02746991) [5].


Feb 16: pSivida initiated a PIII trial to evaluate the efficacy and safety of the MK II inserter and the safety of fluocinolone acetonide intravitreal insert in patients with posterior segment non-infectious uveitis (PSV-FAI-006; NCT02748512). The open-label, single-group trial will enrol approximately 30 patients in the US [5].


Aug 16: PIII study (n=129) found that Medidur, an injectable micro-insert providing sustained release 0.18mg fluocinolone acetonide at a controlled rate directly to the retina for 3 years, prevented recurrence of disease at six months (p


Dec 15: pSivida announces results from a PIII trial in 129 patients. Posterior uveitis recurred in 18.4% of the Medidur arm vs. 78.6% in the control arm. 10.9% more Medidur-treated eyes than control eyes experienced an increase in intraocular pressure (IOP) above 21 mmHg through 6 months. And 2.3% of the Medidur group required a procedure to reduce IOP in the 6 months vs. none in the sham group. The plan now is to proceed with a second PIII trial, gathering more 6-month and follow-up data [3].


May 15: Positive masked safety data announced from PIII trial of Medidur for posterior uveitis. At three months, only 4% more study eyes (2/3 of which received Medidur) experienced elevated intraocular pressure (IOP) than the fellow non-study eyes (none of which received Medidur). Initial IOP elevation is an indication of the likelihood of subsequent clinically significant IOP increases. Top line results are expected in Q2 2016 [1].


June 13: A pivotal pIII trial of Medidur was initiated in June 2013 (EudraCT2013-001810-14; NCT01694186), recruiting 120 pts in the US, Germany, Hungary, India, Israel and the UK. The randomised, sham-controlled trial is assessing the efficacy of a 0.18mg fluocinolone acetonide insert in pts with chronic, non-infectious, posterior uveitis, with or without anterior uveitis. The primary endpoint is recurrence of uveitis within 12 months. Top-line results are expected in the second half of 2016 and data. The company is planning a second pIII trial. These two phase III trials are expected to enrol a total of 300 pts [2].

Evidence based evaluations