Eye care company pSivida ($PSDV) will use the $25 million milestone payment for the recent FDA approval of sustained-release therapy Iluvien to fund its pipeline.
pSivida and licensing partner Alimera ($ALIM) were able to convince the FDA to change its mind last month after the agency had rejected the treatment for diabetic macular edema (DME) for the third time. The therapy is administered through a back-of-the-eye implant.
This week the company announced that it has received the milestone payment called for upon FDA approval. "This milestone payment together with our cash on hand should fund our planned product development and other operations into calendar 2017," CEO Paul Ashton said in a statement.
He elaborated on the company's R&D efforts, saying in the statement, "Our lead product candidate, Medidur for the treatment of chronic posterior uveitis, uses the same micro-insert delivering the same drug as Iluvien. Medidur is currently being studied in a pivotal Phase III clinical trial. If the FDA concurs, we plan to file a new drug application for Medidur based on data from this single trial, together with supplementary data from a study of our proprietary inserter. Our preclinical research is focused on use of our Tethadur and Durasert platform technologies to deliver biologics to the eye and systemically and to treat wet and dry age-related macular degeneration, glaucoma and other retinal diseases and osteoarthritis."
In addition to the payment, the company will receive royalties on Iluvien consisting of 20% of the product's net profits. It also receives royalties on its Retisert sustained-release implant for posterior uveitis, licensed to Bausch + Lomb.
The FDA approved Iluvien for use in DME patients who have already gone through standard corticosteroid treatment and didn't experience a significant rise in in-eye pressure, Alimera said. That's a wider label than in Europe, where Iluvien is cleared only for those who have failed other therapies or undergone cataract surgery.
- read the release