Pulse Newsletter | Volume 8 - Issue 3

FDA Approves New Topical Drug for Treatment of Atopic Dermatitis

On February 12, 2026, the U.S. Food and Drug Administration (FDA) approved Adquey™ (difamilast 1%) ointment for the treatment of mild-to-moderate atopic dermatitis (AD), or eczema, in patients 2 years and older. AD is a chronic, inflammatory skin condition characterized by dry, itchy skin and rash. It is common in children but can also occur in adults, affecting more than 9 million children and 16 million adults in the United States. First-line treatment of AD includes the use of topical corticosteroids (TCS), such as hydrocortisone or triamcinolone; however, chronic use of TCS may lead to localized skin side effects, such as thinning of the skin.

Adquey™ was approved by the FDA based on the safety and efficacy results of several randomized, double-blind, placebo-controlled Phase III clinical trials in 615 pediatric and adult patients with AD. Adquey™ demonstrated superior efficacy at Week 4 of the trials based on the Investigator’s Global Assessment (IGA) for atopic dermatitis, a 5-point scale used by clinicians to evaluate overall disease severity in dermatology clinical studies. The IGA scores improved at week 4 by at least 2 grades in 38%-47% of patients using Adquey™ compared to 12%-18% of patients that used placebo. In terms of safety, results of the trial demonstrated that Adquey™ has low levels of systemic absorption and did not cause stinging at the application site. Other similar topical therapies for AD include Eucrisa® (crisaborole) and Zoryve® (roflumilast). During the studies, the most common side effect associated with Adquey™ was nasopharyngitis (common cold), which occurred in 6% of the treatment patients compared to 4% that received placebo. Adquey™ is applied to the affected area of the skin twice daily. Pricing information is not yet available.

FDA Removes Box Warnings for Six Menopausal Therapies

On February 12, 2026, the FDA announced changes to the drug package labeling for six hormone replacement therapy (HRT) products, which are hormone therapies containing estrogen and/or progesterone that are used for the treatment of menopause symptoms such as hot flashes and night sweats. They are also used to prevent bone loss, which can increase risk for fractures. Prior to the change, these drugs had what is called a “black box” warning, or boxed warning, in their package labeling related to increased risk of breast cancer and cardiovascular disease. A “black box” warning is the FDA’s strongest warning for safety concerns for prescription drugs. The information is displayed at the top of the package labeling and highlighted with a bolded black border to ensure healthcare providers and patients are alerted of the serious risks associated with the drug.

HRT drugs have been available for many years. However, following the Women’s Health Initiative (WHI) study that concluded in the early 2000’s, the FDA placed a boxed warning on these medications based on the results of the study linking use in postmenopausal women to an increased risk of breast cancer and cardiovascular disease. The current FDA Commissioner requested a new review of the clinical information available for HRT, and that review resulted in the removal of the boxed warnings for breast cancer, cardiovascular disease and dementia. The review showed that women who initiate HRT within 10 years of the onset of menopause have a reduction in all-cause mortality and bone fractures. The previous warnings limited the use of these products when more women could have been benefitting from them.

In November 2025, the U.S. Department of Health and Human Services (HHS) announced that the FDA would begin the process of removing the warning from HRT drugs. Demand for HRT has steadily increased since then, leading to supply issues and reported shortages of available medications, including estrogen patches.

FDA Approves New Combination Drug for Treatment of Presbyopia

On January 28, 2026, the FDA approved Yuvezzi™ (carbachol and brimonidine tartrate) ophthalmic solution for the treatment of adult patients with presbyopia, which is a gradual loss of close-up vision associated with normal aging that usually occurs around middle age. Yuvezzi™ is the first combination drug FDA-approved for treatment of presbyopia. The recommended dosage of Yuvezzi™ is one drop instilled in each eye once daily. Contact lenses should be removed prior to using Yuvezzi™ and patients should wait at least 10 minutes before reinserting contact lenses. Yuvezzi™ is supplied in a box of 30 single-dose vials. Warnings and precautions of Yuvezzi™ include blurred vision, which may impair your ability to drive, especially at night, or operate machinery, along with more serious, rare risks of retinal damage and iritis. The most common side effects associated with Yuvezzi™ include eye pain and irritation after instillation and headache.

Yuvezzi™ was evaluated for safety and efficacy in two randomized, double-blind, placebo-controlled clinical trials of 536 patients ages 45 to 80 with presbyopia. The clinical endpoint in the trials was improvement in baseline vision by at least 3 lines (15 letters) on an eye chart without a loss in visual acuity. Up to 51% of patients using Yuvezzi™ achieved the clinical endpoint, compared to up to 40% for single agent carbachol or brimonidine, and up to 4% for placebo. Pricing information is not yet available for Yuvezzi™. It is expected to be available in the market in the second quarter of 2026. Alternatives available for the treatment of presbyopia include other prescription eye drops, including Vuity® (pilocarpine), Qlosi™ (pilocarpine) and Vizz™ (aceclidine), along with reading glasses, which are available to purchase over the counter.  

New FDA Approvals

New Drug: Vykoura™ (leucovorin calcium)

Injection approved for use in adult and pediatric patients for rescue therapy after high-dose methotrexate, treatment of anemia due to folic acid deficiency, and treatment of metastatic colorectal cancer in combination with 5-fluorouracil. [2/3/2026 – Avyxa Pharma, LLC.]

New Generics Entering the Marketplace

Zylet^® (loteprednol etabonate and tobramycin)

Indication: For treatment of steroid-responsive inflammatory eye conditions where there is bacterial eye infection or risk of infection. 

Dosage Form/Strength: 0.5%/0.3% ophthalmic suspension

Average Wholesale Price (AWP): Generic = $350 per 5 ml bottle | Brand = $400 per 5ml bottle