pSivida lines up EMA, FDA applications for eye drug/device as 2nd PhIII delivers positive data
Watertown, MA-based pSivida says their lead eye drug for posterior segment uveitis hit the primary endpoint of their second Phase III trial, putting them on track to a European filing this month with an FDA application scheduled to arrive in Q4.
The drug is designed to prevent a recurrence of posterior segment uveitis, which causes blindness, and researchers say that Durasert scored on that mark, with 21.8% in the drug arm experiencing a recurrence compared to 53.8% in the placebo arm.
The biotech’s stock shot up 20%, then began to lose altitude, with shares $PSDV up 12.5% in pre-market trading.
The biotech has had plenty of ups and downs along the way. Its first micro device for injection into the eye — Iluvien, partnered with Alimera — was rejected several times before the FDA got around to approving it in 2014. Durasert is its new lead experimental drug/device, using another insert to deliver meds as the company expands its use in other diseases as well.
This time around, pSivida is planning to keep US commercial rights while looking for a partner to take control of Europe and other ex-US markets.
There was also safety data to report on. The announcement noted that:
•Intraocular pressure (IOP) elevation, which can lead to glaucoma, was 2.4 and 1.3 mm Hg (mean) at six months (vs baseline) for Durasert and sham, respectively.
•Patients requiring IOP-lowering therapy at any time during the first six months follow-up were 41.6% for Durasert and 34.6% for sham. No subject required IOP surgery during the first six months of follow-up.
•In patients with a natural (phakic) lens at baseline, 4.9% in the Durasert group required a cataract surgery through six months compared to 8.6% in the sham group.
“The data from this trial confirms previous clinical research demonstrating our three-year Durasert insert for posterior segment uveitis may significantly help patients suffering from this devastating disease— the third leading cause of blindness,” said pSivida CEO Nancy Lurker.