Results from a Phase III study to evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal insert (FAI, “Medidur”), for the treatment of non-infectious uveitis, has reported high statistical significance in its primary endpoint of prevention of recurrence of disease at six months (p < 0.00000001). According to the sponsor of the study, pSivida, a US-based drug delivery company, 0.18mg intravitreal Medidur met the primary endpoint of a lower recurrence rate of posterior uveitis at 6 months compared to a sham injection acting as the control (18.4% vs. 78.6%). Following the announcement of results from the study, conducted in 129 patients, the company stated that it plans to file for EU marketing approval for the product to treat chronic non-infectious uveitis of the posterior segment of the eye (posterior uveitis). The company referenced advice from the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) indicating that, “an application for a product treating a condition like posterior uveitis could be based on statistically compelling and clinically relevant results from just one pivotal trial.”
The pSivida summary data indicated that treated eyes had an ≥15 letter improvement on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart from baseline to 6 months, compared to 4.9% of eyes treated with the sham injection (p=0.011). In addition, 4.6% of treated eyes showed an ≥15 letter decrease on the ETDRS eye chart from baseline to 6 month, compared to 31% of eyes receiving the sham injection (p<0.0001). Despite the positive outcomes almost 28% of patients receiving the insert are understood to have experienced an increase in intraocular pressure (IOP) above 21 mmHg, compared to almost 17% of control participants. By the 6 month time-point, 2.3% of treated eyes required a surgical procedure to reduce the increased IOP, while no such intervention was required in control subjects. Given the same product is approved as Iluvien in the U.S. and 17 EU countries for the treatment of diabetic macular edema (DME), the company will aim to partially use Iluvien clinical data to support an EU application for the posterior uveitis indication.
Commenting on the clinical announcement, Paul Ashton, CEO of pSivida Corporation stated, “We are delighted with this advice provided by the MHRA. We expect the high statistical significance of the efficacy data, clinical benefits and positive safety data in our first trial will meet the criteria used by MHRA and other EU regulatory authorities to approve a product on the basis of a single pivotal study. Using data from a single clinical trial would significantly accelerate our filing for EU marketing approval for Medidur. As posterior uveitis affects a similar number of people in the EU and the U.S., accelerated approval in the important EU market would be very beneficial to us.”