pSivida (ASX: PVA) says its full-year 2015 result reflects strong progress toward its goal of becoming the leader in sustained release drug delivery products in ophthalmology and beyond.
Revenues for the year totaled $26.6 million compared to $3.5 million for the previous year.
According to the company, the increase reflects the $25 million milestone for FDA approval of Iluvien, partially offset by an approximate $1.8 million reduction in revenues from funded technology evaluation agreements.
Operating expenses for the year totaled $20.1 million compared to $17 million for the previous year, with the company attributing the $3.1 million net increase to higher CRO costs for the Medidur clinical development program as well as increased professional fees and stock-based compensation.
The company said Phase 3 clinical trials for Medidur for the treatment of posterior uveitis, pSivida’s lead development product, continued "on pace" for an expected NDA filing in the first half of 2017.
"Enrolment of the first trial was completed in March 2015, and enrolment in the second trial is ongoing," it said. "Medidur is designed to deliver three years of treatment of posterior uveitis, a blinding eye disease, from a single injection."
According to Paul Ashton, Ph.D., President and CEO of pSivida, “We remain optimistic that Medidur will be safe and effective in treating posterior uveitis. Recent top-line results from an investigator-sponsored study and safety data from our first Phase III trial have been very encouraging in this regard.”
The top-line results from the study of low and high doses of Medidur (pSivida is studying only the low dose) showed a statistically significant reduction in the recurrence of uveitis (p=0.014) and a statistically significant improvement in visual acuity (p=0.014) in eyes treated with Medidur compared to those that were not treated with the therapy.
pSivida said it expects that an IND will shortly be filed in the US to commence an investigator-sponsored study of an implant utilising its Durasert technology to treat pain associated with severe osteoarthritis of the knee.
"It will be surgically implanted in the knee to provide approximately six months of sustained delivery of a corticosteroid directly to the joint, designed to offer long-term pain relief and delay or eliminate the need for knee replacement surgery," said the company.
“With over 10 million cases of knee osteoarthritis and 700,000 knee replacement surgeries last year in the U.S. alone and a population that is aging and increasingly overweight, a product that would offer a new treatment alternative for the pain of severe osteoarthritis of the knee would be a very welcome clinical development,” said Dr Ashton.
Iluvien for diabetic macular edema, the company's lead licensed product, which is the same micro-insert as Medidur, completed its first quarter of commercialisation in the US with solid sales.
The therapy is also sold in the UK, and was recently launched in Portugal and relaunched in Germany. 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.
“We believe the three years of effective treatment from a single injection of Iluvien should make it a very attractive treatment alternative in the significant DME market, and we look forward to benefitting through our profit participation,” said Dr Ashton.
“Our $28.5 million in cash at the end of fiscal year 2015 marks our highest year-end liquidity. It should give us the capital resources to continue our planned product development programs, including our two Medidur trials, into early 2017, even without any potential future payments arising from ILUVIEN,” he added.