News
Oculus Innovative Sciences Announces Fiscal Third Quarter 2008 Quarterly Results and Clinical Update
Oculus Innovative Sciences, Inc. today announced quarterly results for its fiscal third quarter of 2008, ended December 31, 2007.
Hoji Alimi, CEO and founder, stated, "Our results for the quarter are aligned with Oculus' strategic direction -- to reduce costs in the international markets and primarily invest in U.S. clinical trials to support FDA approval of Microcyn Technology as a drug. The execution of this strategy was reflected during the most recent quarter by a 57% decline in international operating expenses and 5% growth in product revenue. This quarter was significant for Oculus as we completed our Phase II clinical trial of Microcyn Technology in patients with mildly infected diabetic foot ulcers. As we had advised, we completed the trial before the end of 2007 and expect to report top-line data at DFCon 08, one of the world's premier annual conferences focused on diabetic foot ulcers.
"The primary objective of this Phase II trial is to establish a baseline of safety and to identify strong trends relative to the clinical benefits of Microcyn in combination therapy with levofloxacin, which is a systemic antibiotic, and as a monotherapy. The trial was not designed as a superiority study. The primary endpoint is cure or improvement of infection, with microbiological response, safety, and wound healing as the secondary and exploratory endpoints. This design provides various options for analyzing the data, which should provide important information for designing the Phase III trial."
The recently completed Phase II trial included three different treatment arms for evaluation: 1) topical Microcyn alone; 2) topical Microcyn in combination with oral levofloxacin; and 3) oral levofloxacin plus topical saline. Each patient received 10 days of treatment with a 14-day follow-up. Designed into the trial were three assessment time points at days three, 10, and 24.
"As a result of our focus on the U.S. clinical program, we have allocated our financial and management resources to the clinical trials while reducing our international costs," Alimi added. "We continue to rely on partners to grow our sales to international markets, including China and India. During the most recent quarter, China Bao Tai, our partner in China, completed two randomized clinical trials of Microcyn and submitted data to the SFDA requesting approval of Microcyn-based products in China."