A dry eye drug that’s being co-developed by Irvine-based Allergan Inc. faces an uncertain future after failing yet another clinical trial.
Inspire Pharmaceuticals Inc. of Durham, N.C., said last month that Prolacria, its experimental drug for treating dry eyes, failed to meet the main goal of a late-stage clinical trial.
Inspire provided preliminary results of the trial to Allergan, “and we will be conducting a thorough review of the program before determining next steps, if any,” said Christy Shaffer, Inspire’s chief executive, in a statement.
Allergan spokeswoman Caroline Van Hove said she couldn’t comment because the trial data was being fully analyzed.
Allergan sells Restasis, which became the first Food and Drug Administration-approved drug to treat dry eye back in 2002. Allergan worked with Inspire to develop Restasis and has said it saw Prolacria as a possible complement to Restasis.
Inspire’s shares closed down about 12% on Jan. 21, when the news was announced. The company counted a recent market value of $460 million.
Meanwhile, analyst Liana Moussatos of Los Angeles-based Wedbush Morgan Securities said in a client note that she thought Prolacria was “dead” and that she was expecting the drug to fail based on mixed clinical data in the past.
Prolacria already has been through four late-stage clinical trials and was being studied under a special protocol assessment agreement with regulators.
Inspire and Allergan signed a deal to develop Restasis and Prolacria in 2001.
Vertos Study
Aliso Viejo-based Vertos Medical Inc. said that it just completed enrolling 75 patients in a study of its minimally invasive procedure for treating symptomatic central canal spinal stenosis, or a narrowing of the spinal cord.
The procedure is called mild, for minimally invasive lumbar decompression.
Vertos already received Food and Drug Administration approval to sell mild but is further studying its effects. The company has begun training doctors to support the commercial launch of the procedure.
The device maker also said that it has seven other post-market studies under way to look at mild.
Vertos, which is run by Orange County medical device veteran Jim Corbett, received a $15.5 million fourth round of venture capital funding last fall.
Vertos has raised $32.5 million since its 2005 founding.
I-Flow Lawsuit
I-Flow Corp., a Lake Forest device maker that’s now part of Kimberly-Clark Corp.’s healthcare unit, is ensnared in a series of lawsuits filed by lawyers seizing on an issue about pain pumps and shoulder damage.
Houston-based law firm Arnold & Itkin LLP recently filed five lawsuits against makers of pain pumps, including I-Flow, alleging their devices cause irreversible shoulder damage among patients.
The firm said it was representing 28 people who received pumps to manage pain following shoulder surgery. The pumps use catheters to continuously deliver pain drugs to the shoulder.
The suits allege that the device makers continued to promote the use of pain pumps to manage pain in shoulder joints even though the Food and Drug Administration denied approval for using these pumps for shoulder joints.
A Kimberly-Clark spokeswoman declined comment because the lawsuit is in active litigation.
Besides I-Flow, other companies named in the suits include Stryker Corp., Abbott Laboratories and Hospira Inc.
Abbott Laboratories runs eye device maker Abbott Medical Optics Inc. of Santa Ana.
Orange Coast Opens Center
Fountain Valley’s Orange Coast Memorial Medical Center recently opened what it says is the county’s first facility designed for open-heart surgeries and procedures based on catheters, such as angioplasties.
The hospital calls the facility a hybrid interventional cardiac suite.
The suite can accommodate cardiologists, cardiac surgeons, vascular surgeons and interventional radiologists, as well as sister facility Long Beach Memorial Medical Center’s heart surgery team.
Bits and Pieces:
Skilled Healthcare Group Inc., a Foothill Ranch-based nursing home provider, was downgraded earlier this month by Bank of America Merrill Lynch to underperform from neutral as part of a wider update on the healthcare sector. Bank of America Merrill Lynch said its Skilled downgrade was due to a bearish outlook for skilled nursing facilities … B. Braun Medical Inc., which has a large Irvine operation, said it introduced the WHIN Safe Huber needle, a medical device that helps healthcare workers avoid needle-stick injuries and exposure to blood and body fluids … Irvine’s EDI Health Group Inc. said that it released electronic insurance claim processing software with dental insurer Ameritas Group, part of UNIFI Mutual Holding Co. The product is based on EDI’s ClaimConnect and allows dentists to submit claim files from their practice management software or through direct data entry with online claim tracking … Amerita Inc., an Irvine company that provides intravenous drugs to patients in their homes, said it bought Chartwell Rocky Mountain LLP in Denver for an undisclosed price. Chartwell was a venture between the University of Colorado Hospital and Chartwell Home Therapies.
