The HCPFive: Top News for Healthcare Providers from the Week of 05/25

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration (FDA) approval of a new dry eye disease (DED) drug, a first-of-its-kind oral hydrocortisone solution for adrenal insufficiency, the failure of a Phase 3 trial for AL amyloidosis, a Priority Review granted for IgA nephropathy (IgAN), and new surgical guidelines for treating chronic rhinosinusitis.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of May 18, 2025—let’s jump in!

Interested in oncology news? Check out The OncFive, from our sister publication OncLive.

FDA Approves Acoltremon Ophthalmic Solution (TRYPTYR) for Dry Eye Disease

The FDA approved acoltremon ophthalmic solution .003% (TRYPTYR), formerly AR-15512, a first-in-class transient receptor potential melastatin 8 channel (TRPM8) receptor agonist that stimulates corneal sensory nerves, to treat signs and symptoms of DED. Approval was awarded to Alcon based on positive data from two Phase 3 clinical trials, COMET-2 and COMET-3, analyzing more than 930 patients with DED.

FDA Approves Hydrocortisone Oral Solution for Adrenal Insufficiency

The FDA approved hydrocortisone (KHINDIVI) oral solution as a replacement therapy in pediatric patients aged 5 years and older with adrenocortical insufficiency. Awarded to Eton Pharmaceuticals, this approval marked the first FDA-approved oral solution formulation of hydrocortisone, designed to address administration and dosing accuracy in patients who may have special requirements.

Birtamimab Misses Primary Phase 3 Endpoint for AL Amyloidosis

Birtamimab missed the primary endpoint in the Phase 3 AFFIRM-AL clinical trial for the treatment of AL amyloidosis, resulting in the discontinuation of development and the halt of the open-label extension. As a result, Prothena Corporation announced plans to cut operating costs and significantly shrink its workforce, with further details on the matter expected in June.

FDA Accepts, Grants Priority Review to Sibeprenlimab BLA for IgA Nephropathy

The FDA accepted and granted Priority Review to the Biologics License Application (BLA) for sibeprenlimab for the treatment of IgAN. Supported by positive data from the Phase 3 VISIONARY trial, the BLA was assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 28, 2025.

New Guidelines Outline When to Consider Sinus Surgery for Chronic Rhinosinusitis

The American Academy of Otolaryngology-Head and Neck Surgery Foundation released new clinical practice guidelines for the surgical management of chronic rhinosinusitis. The guidelines, targeted for otolaryngologist-head and neck surgeons who manage adults with chronic rhinosinusitis, provided 11 evidence-based key action statements to inform the main surgery options for chronic sinus problems and additional treatments or follow-up procedures.