Category: Alimera Sciences
The UK's National Institute for Health & Care Excellence OK's pSivida's Iluvien drug/device combo for cataract surgery patients with chronic diabetic macular edema.
pSivida (NSDQ:PSDV) said the UK's National Institute for Health & Care Excellence approved its Iluvien drug/device combination.
The approval is for cataract surgery patients who don't respond to standard treatment for diabetic macular edema, according to a press release.
Wall Street flees from pSivida and licensee Alimera Sciences as the FDA hands down its 3rd rejection for the Iluvien vision repair implant.
France grants Alimera's Iluvien vision repair implant national insurance coverage, with up to 100% reimbursement for certain patients.
The French National Health Authority granted Alimera Sciences (NSDQ:ALIM) national insurance coverage for the Iluvien vision repair implant, the company said this week.
pSivida kicks off enrollment in the 1st of 2 planned efficacy trials for a drug/device combo to treat eye inflammation and prevent vision loss.
pSivida (NSDQ:PSDV) started recruiting patients in a Phase III U.S. trial for its eyelash-sized drug/device combination, an implant designed to treat ocular swelling that can lead to blindness.
German healthcare regulators approve pSivida’s Iluvien drug-device combination product for treatment of diabetic macular edema.
pSivida's (NSDQ:PSDV) announced that it won German approval for its Iluvien drug-device combination, launching immediately and touting the 1st commercial treatment this month in Deutschland on a patient with diabetic macular edema.
Massachusetts medical device maker pSivida is highlighting the safety of its Iluvien drug-device combination in hopes of finally winning FDA approval for treating patients with diabetic macular edema.
As pSivida gears up to begin distribution of its Illuvien eye treatment in Europe, it plans to re-submit its new drug application to the FDA for the drug/device combination.
It's been a rocky road for pSivida's (NSDQ:PSDV) Illuvien, a drug/device combination for diabetic macular edema, but the company hopes that new trial data will pave the way to regulatory approval in the U.S.