Nicox SA has entered into an exclusive research and license option agreement with Glaukos Corp. for NCX-1728, Nicox’s novel nitric oxide (NO)-donating phosphodiesterase PDE5 inhibitor.
Glaukos Corp. brought home a nice year-end gift for investors with a broad U.S. FDA approval for the Idose TR. Indicated for use in patients with primary open-angle glaucoma or ocular hypertension across the full range of disease severity, the device/drug combo provides continuous release of a prostaglandin analog that reduces intraocular pressure via a titanium device implanted through a corneal incision for up to three years.
Beneficiaries in the U.S. Medicare program have access to several technologies and procedures for treatment of glaucoma, but Medicare administrative contractors (MACs) seem to be looking sideways at some of these offerings. Both Wisconsin Physician Services and Palmetto GBA have floated draft local coverage proposals that deem procedures such as goniotomy and the combination of canaloplasty and trabeculectomy to be investigational, suggesting that claims for these and other services and devices will not be paid by these MACs.
The American Academy of Ophthalmology (AAO) annual meeting in Chicago Sept. 30 to Oct. 3 covered the waterfront in the ophthalmic market, with positive signs for continued or improving health as supply kinks work out. Hurricane Ian’s impact on the other side of the country was also a topic, as Florida accounts for a disproportionate percentage of cataract surgeries, which may be delayed as a result of the destruction in the state. We provide some highlights from the conference, analysts’ meetings with company executives and some timely new developments in the sector.
Glaukos Corp. received a green light from the FDA for its Iprime device for the delivery of viscoelastic fluid during ophthalmic surgery, which could help the company to recover some of the revenue lost by cuts to reimbursement for its minimally invasive glaucoma surgery (MIGS) product, Istent. A launch date has not been announced.
Alcon AG plans to acquire Ivantis Inc. for $475 million at closing, regaining a significant position in the lucrative minimally invasive glaucoma surgery (MIGS) space through the addition of the Hydrus microstent device to its ophthalmology portfolio. In addition to the up-front payment, the deal includes additional unspecified contingent payments dependent on achievement of certain milestones. The transaction is expected to close in the first quarter of 2022.
Glaukos Corp., of San Clemente, Calif., has taken another step forward in obtaining global market access for its Istent device for glaucoma with a positive coverage recommendation in Canada. Health Quality Ontario (HQO) has recommended that taxpayer dollars be used to cover the device in conjunction with cataract surgery, although the endorsement is limited to patients with mild to moderate glaucoma that is not well controlled with pressure-lowering medications.
Sight Sciences Inc. may have visions of a substantial settlement following Ivantis Inc.’s $60 million settlement with Glaukos Corp. this week or the Menlo Park, Calif.-based company may have its sights set on knocking a competitor out of the market entirely. Both are possible outcomes of the suit Sight Sciences announced this morning that alleges infringement of four of its patents by Ivantis for its Hydrus Microstent. Sight Sciences makes the Omni surgical system, which competes with the Hydrus and the Glaukos Istent in the minimally invasive glaucoma surgery (MIGS) space.
After three years of litigation and nearly a decade of skirmishes, Ivantis Inc. settled with Glaukos Corp. for $60 million to be paid in two installments, with the first $30 million due by Dec. 31, 2021, and the second $30 million by Dec. 31, 2022. In addition, Irvine, Calif.-based Ivantis will pay Glaukos a 10% royalty through April 26, 2025, on sales of Ivantis’ Hydrus Microstent in the U.S. or international sales supplied out of the U.S. With just two weeks to go until their scheduled court date of Sept. 28, the companies finally saw eye-to-eye, reaching a cross-licensing agreement and hammering out a covenant to refrain from future litigation regarding the technologies involved in the Hydrus or Glaukos’s Istent, both used to treat glaucoma.
Glaukos Corp. reported 12-month results from the pivotal IDE trial of its Istent Infinite trabecular micro-bypass system, showing substantial reduction in mean diurnal intraocular pressure (IOP) in patients with open-angle glaucoma uncontrolled by prior surgery or medication. The company is targeting U.S. FDA approval of the device for standalone moderate-to-severe glaucoma in late 2021.
