West Coast Editor

Following up the merger with Australia-based Regenera Ltd. in a $31 million deal, Advanced Ocular Systems Ltd. broadened its intellectual property base by acquiring patent applications that, if granted, could cover the ocular use of anti-VEGF agents such as Genentech Inc.’s Avastin.

"It actually covers the [whole] category of anti-VEGFs," said Kenneth Taylor, president and CEO of Marblehead, Mass.-based AOS. "We happened to mention Avastin because there’s been a lot of interest in that."

South San Francisco-based Genentech’s Avastin (bevacizumab) is approved for metastatic colorectal cancer in the first-line setting when combined with 5-FU-based chemotherapy. The company has another anti-VEGF drug, Lucentis (ranibizumab) for neovascular wet age-related macular degeneration, for which a biologics license application was submitted early this year. (See BioWorld Today, Jan. 3, 2006, and Feb. 14, 2006.)

"You have anti-angiogenic approaches [with compounds targeting VEGF, as used against cancer] and anti-inflammatory approaches," Taylor pointed out. The patent applications acquired from MINU LLC, of Pittsboro, N.C., cover anti-VEGFs as used alone or in combination with a range of anti-inflammatory agents, including anti-VEGF molecules.

The applications bolster others held by AOS relating to combination therapies involving the ocular use of the steroid triamcinolone acetonide (TA) with anti-VEGF agents in the treatment of retinal diseases, such as age-related macular degeneration and diabetic retinopathy.

In 2005, TA was licensed to Alcon Inc., of Ft. Worth, Texas, for the manufacture, sales and distribution of a product used as a method for surgeons to better see the vitreous during the surgical procedure called vitrectomy.

"When a surgeon has to remove the jelly in back of the eye, there are very thin membranes that are transparent, and TA makes them slightly opaque," Taylor said, adding that TA has been used off label in "thousands" of vitrectomy procedures annually, and Alcon hopes to have an approved indication in a year or so.

It’s also used off label as a co-therapy for AMD patients, primarily with Visudyne, (verteporfin), the photodynamic therapy from QLT Inc., of Vancouver, British Columbia.

"On the order of nearly 80 percent of Visudyne treatments are done as co-therapy, with TA injected at the same time," Taylor said. "Ultimately, we will have an approved indication," he said, and the approach could prove synergistic with other AMD treatments.

At the start of the year, shareholders of Perth, Australia-based Regenera gave their approval to the company’s merger with AOS. Regenera agreed to issue a maximum of 100.8 million shares to AOS shareholders.

"One of the rationales for merging is that we’ve balanced our time-to-market profile," Taylor told BioWorld Today. "With Regenera, we have early products coming to market with the Alcon relationship, [as well as] some that take longer to develop - the AMD indication and some others."

AOS, for its part, has market possibilities that will follow "in a couple of years," including an intraocular lens to be used for cataract surgery.