Santa Ana-based Abbott Medical Optics, a unit of Abbott Laboratories in Chicago, scored a regulatory approval this month.
Abbott Medical said the Food and Drug Administration approved its Tecnis Symfony intraocular lens this month for cataract treatment.
The device maker said in a news release that Tecnis Symfony is the only intraocular lens that “[provides] a full range of continuous high-quality vision following cataract surgery, while also mitigating the effects of presbyopia by helping people focus on near objects.”
Tecnis Symfony Toric, a version of the lens for people who have astigmatism, also is covered by the regulatory action, Abbott Medical said. Astigmatism occurs when a person’s cornea is misshapen, causing blurry or distorted vision.
The potential market for Tecnis Symfony is large, according to Abbott Medical. The company quoted statistics from St. Louis-based market tracker Market Scope LLC showing that almost 4 million contact surgeries are performed each year, a number that’s projected to increase.
“Symfony offers patients, including those with astigmatism, an option for crisp, clear vision at all distances,” said Thomas Frinzi, senior vice president of Abbott’s vision business.
Tecnis Symfony “is an important addition to our portfolio of lenses, as we expect many patients to choose a Symfony lens over a standard monofocal lens, given its benefits,” he said.
The lens already is approved in more than 50 countries and has been heavily studied. Abbott said there’s data from clinical studies involving more than 2,000 eyes.
Abbott Medical Optics makes a variety of devices used in cataract and vision-correction surgeries, along with contact lens care products. The company was known as Advanced Medical Optics before Abbott acquired it in 2009.
Allergan Seeks Dry-Eye OK
Allergan PLC, in other FDA news, is seeking regulatory approval for a device that falls under the company’s Irvine eye drug hub.
It said last week that it filed what’s called a “de novo” application with the FDA for its Oculeve Intranasal Tear Neurostimulator, which is designed to temporarily increase tear production in patients with dry-eye disease. The company said in a news release that a pair of pivotal clinical trials of Oculeve met its effectiveness goals.
Allergan already is a major player in the dry eye market through its Restasis eye drops.
The FDA says a de novo application provides an approval pathway for medical devices “for which general and/or special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.”
Allergan, which is based in Dublin, Ireland, for tax purposes and primarily operates from New Jersey, got Oculeve when it bought South San Francisco-based Oculeve Inc. last year for $125 million, plus milestone payments.
Allergan separately said it and Teva Pharmaceutical Industries Ltd., an Israel-based company, had made some changes to their $40 billion deal involving the divestment of the former’s generic drug business to Teva.
The adjustments included a $221 million reduction in the deal’s cash consideration, adding a pair of generic drugs to a list of excluded products, and to increasing the base working capital adjustment.
Peregrine Licenses Tech
Tustin-based drug developer Peregrine Pharmaceuticals Inc. licensed the rights to cancer-detection and monitoring technology from the University of Texas Southwestern Medical Center.
The biopharmaceutical company is engaged in developing various therapies for cancers. It also has Avid Biosciences Inc., a wholly owned subsidiary providing development and biomanufacturing for Peregrine and third-party customers.
The company said the technology is based on exosomes, which are small sacs in the body derived from cells, and could be developed into a blood test to either detect or monitor cancer.
UCI Hosts Cannabinoid Event
The University of California-Irvine will host “The End of Opiates” next month at its Gillespie Neuroscience Research facility on campus.
The Aug. 26 event will cover the issue of “continual opioid use and the abuse it can lead to and why cannabidinol research is important,” according to a news release from Irvine-based co-presenter Cultivation Technologies Inc.
Cultivation Technologies President Justin Beck will be a featured speaker. The company is planning to build a facility in Coachella that will manufacture, test and distribute cannabinoid-based drugs.
The forum also will include panels discussing professional athletes and pain management, among other things.
Cultivation Technologies and Abecis Pharma are sponsoring the forum.
