An NDA for the lower of the two doses evaluated is planned for the second quarter of 2010.

pSivida says that a Phase III program with its treatment for diabetic macular edema (DME), Iluvien, successfully achieved the primary endpoint of demonstrating efficacy in both the high and low dose that were tested. Partner Alimera Sciences plans to file for approval of the low dose of Iluvien for the treatment of DME in the second quarter of 2010, followed by registration filings in various European countries and Canada.

Submission of the NDA will be based on the month-24 safety and efficacy data culled from the Phase III program (FAME), which  consisted of two separate trials (trial A and trial B). The companies say that 956 patients with DME were randomized to receive either high-dose Iluvien (0.45 µg/day), a low-dose Iluvien (0.23 µg/day), or a sham insertion.

Safety data showed that intraocular pressure of 30 millimeters of mercury or greater were seen in 21.6% of the high-dose patients and 16.3% of the low-dose patients. Over the 24-month period, 5.1% of patients receiving the high dose and 2.1% of the patients receiving the low dose had received a filter surgery to reduce their eye pressure.

The primary efficacy endpoint was the difference in the percentage of patients between the treatment and control groups whose best corrected visual acuity (BCVA) improved by 15 or more letters from baseline at month 24. Statistical significance for both doses of Iluvien in each of trial A and trial B as well as on a combined basis was observed. In addition, both low- and high-dose Iluvien showed greater numerical efficacy at month 24 than at month 18, a requirement for approval with 24-month data, the companies report.

“We look forward to the continued benefits of our agreement with Alimera, including a $25 million milestone payment that would be due on approval of Iluvien, profit participation on sales of Iluvien, and payment of the $15 million conditional note from Alimera,” remarks Paul Ashton, Ph.D., president and CEO of pSivida. “If the note is not paid by April 2010, the annual interest rate increases to 20% (to be paid quarterly), and Alimera is to begin monthly principal payments of $500,000.”

Under the terms of the license agreement between the companies, if Iluvien is approved, pSivida will earn 20% of profits. Alimera has rights to pSivida’s Medidur™ drug-delivery technology for the development of Iluvien and certain other ophthalmic products.

Iluvien is pSivida’s lead therapeutic candidate. Besides DME, it is also being studied in Phase II as a treatment for dry and wet age-related macular degeneration.

Previous articlePart 2—Tips for Biotech/Pharma Complainants and Respondents When Going to the ITC
Next articleTeva-Kowa to Take Majority Stake in Taisho Pharmaceuticals