pSivida (ASX:PVA) announced financial results for the three months to March, highlighted by the US launch of ILUVIEN for diabetic macular edema (DME).
ILUVIEN is distributed in the US under a license agreement with Alimera Sciences. It is indicated in the US for the treatment of DME in patients previously treated with a course of corticosteroids without a clinically significant rise in intraocular pressure.
ILUVIEN was also launched in Portugal in the quarter, making it the third EU market. It has been sold in the UK and Germany since 2013.
Three more EU countries granted approvals in the quarter, completing the last applications and bringing the number of EU country approvals to 17. ILUVIEN is indicated in the EU for treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies.
"We are very pleased ILUVIEN has been launched in the US. The efficacy and three-year treatment duration of ILUVIEN should make it a very attractive treatment alternative for patients with clinically significant DME in comparison to anti-VEGF therapy, which requires frequent injections and may not optimally manage the disease," said Paul Ashton, Ph.D., President and CEO of pSivida.
"Our licensee, Alimera Sciences, is making a significant investment in the US launch, which we are optimistic will ultimately benefit us through our net profit participation from US sales."
pSivida is entitled to 20 per cent of the net profits from sales of ILUVIEN by its licensee on a country-by-country, quarter-by-quarter basis and 20 per cent of royalties and 33 per cent of other amounts from sublicenses of ILUVIEN.
For the quarter, the company announced revenues of $328,000 compared to $2 million for the corresponding period last year.
The company attributed the decrease to recognition of $1.5 million in the prior year quarter under a completed feasibility study agreement and lower Retisert royalties.
Net loss for the quarter was $5 million, or $0.17 per share, compared to a net loss of $2.2 million, or $0.08 per share, for the prior year quarter.
Revenues for the nine months to March 2015 totalled $26.2 million compared to $3.2 million for the nine months to March 2014. The increase reflected the $25 million milestone payment for FDA approval of ILUVIEN.