Patients urged to discontinue use of EzriCare and Delsam Pharma artificial tears.
Since its initial statement in January, the CDC reported more cases of vision loss and death due to the extensively drug-resistant strain of Pseudomonas aeruginosa found in some artificial tears. Patients are urged to stop using EzriCare or Delsam Pharma’s Artificial Tears (both manufactured by Global Pharma Healthcare), pending additional information and guidance from the CDC and FDA. In addition, the FDA has warned consumers and health-care professionals not to purchase or use Delsam Pharma’s Artificial Eye Ointment due to potential bacterial contamination.
As of March 14, 2023, the CDC, in partnership with state and local health departments, identified 68 patients in 16 states (Calif., Colo., Conn., Fla. Ill., N.C., N.J., N.M., N.Y., Nev., Pa., S.D., Texas, Utah, Wash., Wis.) with VIM-GES-CRPA, a rare strain of Pseudomonas aeruginosa. Thirty-seven patients were linked to four health-care facility clusters. Three people have died, and there have been eight reports of vision loss and four reports of enucleation. Most patients reported using artificial tears — patients reported over 10 different brands of artificial tears, and some used multiple brands. EzriCare Artificial Tears, an over-the-counter product packaged in multidose bottles, was the most commonly reported brand and the only common artificial tears product identified across the four health-care facility clusters. Laboratory testing by the CDC also identified the presence of VIM-GES-CRPA in opened EzriCare bottles from multiple lots.
Delsam Pharma artificial tears were also recalled because they are also produced by Global Pharma Healthcare.
IN THE NEWS
Allergan, an AbbVie company, announced the FDA approved a twice-daily dosing option of VUITY (pilocarpine HCl ophthalmic solution) 1.25% in adults with presbyopia. A second dose (one additional drop in each eye) may be administered 3-6 hours after the first dose. With the approval of twice-daily dosing, the duration of effect of VUITY may be extended for up to 9 hours.
Pixium Vision SA announced the FDA granted Breakthrough Device Designation to the company’s Prima System, a photovoltaic substitute of photoreceptors providing simultaneous use of the central prosthetic and peripheral natural vision implanted in human patients with atrophic dry AMD to partially restore their vision.
Akorn Pharmaceuticals announced it closed all of its US sites and laid off its workforce. The company filed for chapter 7. In March 2022, Théa Pharma announced the completion of its acquisition of seven branded ophthalmic products from Akorn that included: Zioptan, Cosopt, Cosopt PF, Betimol, Azasite, Akten and the ocular surface repair agent AcellFX.
Regeneron Pharmaceuticals reported the FDA gave Priority Review status to its Biologic License Application (BLA) for aflibercept 8 mg for the treatment of wet AMD, diabetic macular edema and diabetic retinopathy. The FDA target action date is June 27, 2023, following the use of a priority review voucher. The BLA is supported by data from two pivotal trials.
Harrow issued a permanent, product-specific J-code for IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia. The IHEEZO J-code (J2403) became effective April 1, 2023. Harrow also announced the CMS approved transitional pass-through reimbursement status for IHEEZO.
IVERIC bio announced an analysis from the avacincaptad pegol (ACP) GATHER clinical trial program that evaluated reduction in vision loss with ACP 2 mg vs sham treatment. The trials were designed to evaluate the rate of geographic atrophy (GA) lesion growth in patients with GA secondary to AMD. The analysis for vision loss from these pivotal studies signals up to a 59% reduction in rate of vision loss with ACP 2 mg compared to sham treatment at 12 months.
CMS announced a lower-than-expected 1.1% average cut of 2024 reimbursement rates for health insurers that offer coverage through the Medicare Advantage program, Reuters reports. CMS said it anticipates a payment increase for MA plans of 3.32% from 2023 to 2024, which is approximately a $13.8 billion increase in MA payments for next year.
Pharmedica USA, with the knowledge of the FDA, issued a voluntary worldwide recall of two lots of Purely Soothing, 15% MSM Drops due to non-sterility. Customers should immediately stop using the product.