Johnson & Johnson on Thursday presented detailed results from its Phase 2/3 ENERGY study showing that IMAAVY (nipocalimab-aahu) achieved a statistically significant, durable hemoglobin response in patients with warm autoimmune hemolytic anemia (wAIHA). The randomized, placebo-controlled trial demonstrated that approximately three times as many patients achieved durable hemoglobin levels versus placebo by 24 weeks in the 30 mg/kg treatment group. These results mark a potential advancement for a rare, life-threatening condition with no FDA-approved therapies.

The primary endpoint of the study was durable hemoglobin improvement, defined as an increase from baseline of at least 2 g/dL, a concentration of at least 10 g/dL, maintained for at least three visits over 28 days starting by Week 16, without rescue therapy. In the 30 mg/kg group, a mean increase of 1 g/dL in hemoglobin was observed at Week 1, compared to no change in the placebo group. Nearly two-thirds of patients achieved both target hemoglobin levels by Week 24.

Key Findings from the ENERGY Study

The study evaluated the efficacy and safety of nipocalimab compared with placebo in adults living with wAIHA. Key secondary endpoints included improvements in fatigue and reduction in steroid use. Changes in patient-reported fatigue were observed as early as Week 2 and sustained throughout the 24-week treatment period.

IMAAVY demonstrated a safety profile consistent with its established profile in generalized myasthenia gravis. The most common adverse reactions in patients with wAIHA treated with IMAAVY were peripheral edema, diarrhea, and fever. The drug is designed to target pathogenic immunoglobulin G (IgG) autoantibodies while preserving key immune functions.

"These data from the Phase 2/3 ENERGY study showed the rapid onset of effect and durable improvement in anemia which occurs by targeting the autoantibody-mediated destruction of red blood cells," said Bruno Fattizzo, M.D., Assistant Professor at the Department of Oncology and Hematology-Oncology, University of Milan, Italy.

The results support the supplemental Biologics License Application (sBLA) for IMAAVY, which has been granted U.S. FDA Priority Review. The legal manufacturer for IMAAVY is Janssen Biotech, Inc., a Johnson & Johnson company.

Johnson & Johnson is expanding the U.S. roll-out of its latest advancement in presbyopia-correcting intraocular lenses (PC-IOLs). The TECNIS PureSee IOL is an extended depth of focus (EDOF) lens designed to support visual clarity and quality for patients undergoing cataract surgery. This expansion aims to increase access to a lens that addresses both cataract-related vision loss and the effects of presbyopia. The device is the first and only U.S. FDA-approved EDOF IOL with no warning on loss of contrast sensitivity, a key factor in visual quality, particularly in low-light conditions.

Clinical Performance and Patient Outcomes

The TECNIS PureSee IOL has demonstrated clinical results regarding visual symptoms and patient satisfaction. Data indicates that over half a million eyes worldwide have experienced an extended range of vision with the lens post-surgery. In clinical investigations, 97% of patients reported no very bothersome visual disturbances, and 97% stated they would recommend the TECNIS PureSee IOL to friends or family.

Technical Specifications and Indications

The TECNIS PureSee IOL is indicated for the visual correction of aphakia in adult patients following cataract removal. It is designed to mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the TECNIS PureSee IOL provides improved intermediate visual acuity while maintaining comparable distance visual acuity. The device is intended for capsular bag placement only and must be inserted using the TECNIS SIMPLICITY Delivery System.

Cataract Awareness and Patient Education

The expanded availability coincides with Cataract Awareness Month. Johnson & Johnson has introduced a new patient lifestyle quiz to assist individuals in evaluating their daily activities and vision needs ahead of surgery. Cataracts are a leading cause of vision impairment, affecting nearly 20% of Americans aged 40 and older, yet only 5% have undergone cataract surgery. The company states that the procedure has a success rate of nearly 98% in the U.S.

Management Commentary

Erin Powers, President, Surgical Vision, North America, Johnson & Johnson, stated that the full U.S. availability reflects the company's commitment to innovation and patient satisfaction. She noted that the lens builds on the trusted TECNIS platform to meet patient expectations for vision solutions that support daily lifestyles while providing surgeons with greater flexibility to personalize care.