Watertown, MA-based pSivida ($PSDV) says its late-stage eye drug/device Medidur cleared the first of two Phase III hurdles, posting clear evidence of efficacy over a placebo in preventing posterior uveitis.
Investigators recruited 129 patients for the 6-month study, using a device pSivida developed that is inserted in the back of the eye and delivers a sustained release of corticosteroid. Posterior uveitis recurred in 18.4% of the Medidur arm compared to 78.6% in the control arm. And the biotech reported that it tracked satisfactory safety data, with 10.9% more Medidur-treated eyes than control eyes experiencing 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, compared to none in the sham group.
Researchers tracked an improvement in vision in about 1 in 4 of the Medidur group, with evidence of stabilization in visual acuity as well. Ultimately, pSivida believes Medidur can prove effective against the disease for three years, though it's seeking a regulatory approval with data on a much shorter time frame.
Those numbers fueled a big hike in pSivida's share price this morning, with the stock roaring up 50% in early trading.
The plan now is to proceed with a second Phase III trial, gathering more 6-month and follow-up data to confirm what they saw in the first late-stage study. If all works according to plan, pSivida says it can file for an approval in mid-2017, with a launch in 2018.
The biotech is betting on a smoother approach to a commercial launch than it achieved with their first eye drug, Iluvien, another sustained-release therapy administered through an eye implant to treat diabetic macular edema. Applications from Alimera and pSivida were rejected three times before the FDA finally hit the green light in the fall of 2014.
"The results from this Phase III trial indicate that Medidur has the opportunity to be an effective, safe and convenient treatment for this blinding eye disease, avoiding the potentially serious side-effects and administration compliance challenges of the cycles of systemic steroids, immuno-suppressants and biologics now used to treat the disease," said Dr.
- here's the release