Alimera Sciences announced 3-year followup data from the phase 3 clinical trial for Iluvien 190 micrograms intravitreal implant in applicator for the prevention of relapse in recurrent noninfectious uveitis affecting the posterior segment of the eye (NIPU). The data will support the company’s planned launch of Iluvien for the NIPU indication in Europe during the second half of 2019.
“These data demonstrate the clinical importance of Iluvien as a new treatment option for non-infectious uveitis of the posterior segment, with the ability to significantly reduce disease recurrence in patients for up to 36 months while providing a much longer time to first recurrence as well as less severity of recurrence in most patients,” said Mr. Carlos Pavesio, Specialist Uveitis Consultant Ophthalmologist at Moorfields Eye Hospital, London, UK.
In the 129-patient prospective, randomized, masked clinical trial, patients received a single Iluvien implant or an active control sham injection, and recurrence of NIPU was assessed based on the observation of specified NIPU symptoms or by active treatment by clinicians.
- The median time to first recurrence of NIPU was significantly longer in the Iluvien arm of the trial (657 days/94 weeks), compared to the control sham arm (70.5 days/10 weeks; P < .001).
- The number of recurrences of uveitis was significantly lower in the Iluvien arm (1.7) vs the sham arm (5.3) over the 36 months (P < .001).
- There was a significantly greater improvement (P = .020) from baseline in BVCA in the Iluvien-treated arm (+9.1 letters) compared to sham (+2.5 letters).
- IOP was well-controlled in both arms, mainly by IOP-lowering medication.
- Patients treated with Iluvien had a lower rate of surgery to reduce severe IOP compared to sham (5.7% vs 11.9%), and a higher rate of cataract surgery compared to sham (73.8% vs 23.8%)
“We are very pleased that Iluvien’s Continuous Microdosing technology not only reduces the recurrence of diabetic macular edema but can provide important and sustained benefits in patients diagnosed with non-infectious posterior uveitis,” said Rick Eiswirth, president and CEO of Alimera Sciences. “As we approach the launch of Iluvien for posterior uveitis in our key direct markets of Germany and the UK, we wanted to communicate these important results as we believe this new treatment can provide long-lasting relief and vision-sparing benefits to patients with a single intra-ocular injection.”