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The Rx Recap: July 27-August 1

Key Takeaways

  • Mayo Clinic pioneers alpha-emitting radiopharmaceutical therapy for metastatic breast cancer, enhancing precision in targeting cancer cells while sparing healthy tissue.
  • VIZZ, an aceclidine-based eye drop, receives FDA approval for presbyopia, providing rapid and sustained near vision improvement without myopic shift.
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This week, we feature top articles from our sister publications on regulatory updates, clinical trial insights, and more.

Welcome to this week’s roundup of the most insightful and impactful articles from the sister publications of Dermatology Times, all under One MJH Life Sciences. Our network brings together expert perspectives, clinical advancements, and industry updates to keep clinicians informed and ahead of the curve. From cutting-edge treatments to practice management strategies, here’s a look at the top stories shaping the field of medicine.

Mayo Clinic Treats First Person in the US With a Novel Radiopharmaceutical Therapy for Breast Cancer

Mayo Clinic has become the first site in the US to administer a novel alpha-emitting radiopharmaceutical therapy to a patient with metastatic breast cancer, as part of the ongoing international TRACY-1 clinical trial. Published in OncLive, this early-phase study evaluates actinium-225 DOTATATE (RYZ101), a targeted radiotherapy developed by RayzeBio, now part of Bristol Myers Squibb, for patients with ER-positive, HER2-negative advanced breast cancer expressing somatostatin receptors. Unlike traditional beta-emitting agents, actinium-225 delivers high-energy alpha particles with exceptional precision, aiming to destroy cancer cells while sparing surrounding healthy tissue. Led by Geoffrey Johnson, MD, PhD, Mayo Clinic’s extensive radiopharmaceutical program continues to pioneer next-generation targeted therapies across multiple cancer types.

FDA Approves Lenz Therapeutics’ VIZZ for the Treatment of Presbyopia

Lenz Therapeutics has received FDA approval for VIZZ (aceclidine 1.44%), marking the first and only aceclidine-based eye drop approved for the treatment of presbyopia in adults. Published in Ophthalmology Times, this once-daily, pupil-selective miotic offers rapid and sustained improvement in near vision without inducing myopic shift, showing efficacy within 30 minutes and lasting up to 10 hours. Backed by the Clarity phase 3 trial program, VIZZ met all primary and secondary endpoints and demonstrated a favorable safety profile with mostly mild, transient adverse events. With commercial rollout expected in late 2025, VIZZ introduces a novel, non-invasive option for the estimated 128 million Americans experiencing age-related near vision loss.

FDA Gives Sarepta Green Light to Restart Shipment of DMD Gene Therapy Elevidys to Patients who are Ambulatory

The FDA has recommended that Sarepta Therapeutics lift its voluntary pause on US shipments of delandistrogene moxeparvovec-rokl (Elevidys) for ambulatory patients with Duchenne muscular dystrophy (DMD), as reported by CGTLive. This follows the agency’s completed investigation into the June 2025 death of an 8-year-old boy in Brazil, which was determined to be unrelated to the gene therapy. While the FDA continues to work with Sarepta on updating Elevidys’ safety labeling and evaluating risk mitigation strategies for nonambulatory patients—who remain under a separate voluntary hold—this clearance signals renewed regulatory confidence in the therapy’s use in ambulant individuals. The decision comes amid heightened scrutiny over Sarepta’s AAVrh74 vector platform following multiple deaths, including two linked to acute liver failure in nonambulant DMD patients and a separate incident in a limb-girdle muscular dystrophy trial.

FDA Label Update Positions Inclisiran as First-Line Monotherapy for Hypercholesterolemia

The FDA has approved a significant label update for inclisiran, allowing its use as monotherapy for LDL-C reduction, as reported by Patient Care. Previously indicated only in combination with statins, inclisiran can now be prescribed alongside diet and exercise alone, reflecting confidence in its robust LDL-C-lowering efficacy. The update also revises terminology to “hypercholesterolemia” for clarity and alignment with treatment goals. Administered just twice yearly after initial dosing, inclisiran offers a long-term adherence advantage for patients struggling to meet LDL-C targets—an ongoing challenge for up to 80% of individuals with atherosclerotic cardiovascular disease (ASCVD). This regulatory shift aligns with the latest ACC/AHA guidelines, which emphasize more aggressive LDL-C control, and highlights inclisiran’s growing role in both primary and secondary prevention strategies.

Pharmacists' Guide to Selection and Use of At-Home Blood Pressure Monitors

In Pharmacy Times, experts emphasize the critical importance of accurate and consistent at-home blood pressure (BP) monitoring for individuals with or at risk of hypertension (HTN), a largely asymptomatic yet potentially fatal condition affecting nearly half of US adults. With only 1 in 4 patients achieving controlled BP, the article highlights best practices endorsed by the AHA, including use of validated upper-arm monitors, proper arm positioning, and daily self-monitoring routines. Pharmacists are well positioned to guide patients in selecting reliable devices, educating on correct measurement techniques, and reinforcing lifestyle and medication adherence. New studies also show the significant impact of remote monitoring and telepharmacy on BP outcomes, while data reveal common clinical errors—like improper arm placement—that can skew results and misclassify HTN. As awareness grows around both white coat and masked hypertension, patient self-monitoring emerges as a powerful tool for early intervention, personalized care, and improved cardiovascular outcomes.

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