FDA approves Zyogreen, a ready-to-use indocyanine green for surgical imaging

The Food and Drug Administration has approved Zyogreen, a ready-to-use injectable form of indocyanine green, an optical dye that surgeons use to see structures the naked eye cannot. The approval was recorded in Drugs@FDA on 10 July 2026 under new drug application 218579, held by Provepharm SAS and reviewed on the agency's standard track [s1]. The product is a sterile solution containing 25 mg of indocyanine green in 10 mL, a concentration of 2.5 mg/mL, for intravenous or interstitial use [s1].

Indocyanine green is an old molecule with a long clinical history. What Zyogreen adds is a ready-to-use, pre-mixed presentation of it from a new manufacturer, rather than a new imaging mechanism.

What it does

The dye works in the near-infrared range. When bound to proteins in blood or lymph, indocyanine green absorbs near-infrared light with a peak at 805 nm and re-emits fluorescence at a slightly longer wavelength, peaking at 830 nm [s2]. A fluorescence camera supplies the excitation light and renders the returning glow as a live image on a monitor, so a surgeon can watch blood flow into tissue, trace vessels, or pick out lymph nodes in real time [s2].

The approved uses are broad. The label covers fluorescence imaging of vessels, blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ-transplant, plastic, and micro- and reconstructive surgery, including minimally invasive procedures [s2]. Separate sections of the label cover lymphatic mapping in cervical and uterine cancer and visualisation of the extrahepatic bile ducts [s2]. Dosing is small and setting-specific — for perfusion imaging, adults and children a month or older receive 1.25 mg to 5 mg by intravenous injection [s2].

The evidence for cancer lymph-node mapping

As with many reformulations, the effectiveness of Zyogreen was established on a study of another indocyanine green formulation rather than on fresh trials of this exact product [s2]. The cancer-mapping indication rests on the FILM study (NCT02209532), a randomised, prospective, multi-centre, open-label trial in patients with early-stage uterine or cervical cancer and no clinically evident spread [s2].

FILM randomised 176 patients to receive indocyanine green and a blue dye comparator in either order, injected into the cervix at the start of surgery [s2]. Each patient received four 1 mL injections of a 1.25 mg/mL solution — a total dose of 5 mg — placed at the 3 o'clock and 9 o'clock positions, with a shallow and a deep injection at each [s2]. Surgeons then mapped and removed the highlighted tissue, and pathologists confirmed which specimens were true lymph nodes [s2].

Among the histologically confirmed lymph nodes, 93% were identified using indocyanine green and 43% using the blue dye — a difference of 50 percentage points (95% confidence interval 39% to 60%) [s2]. The patients had a mean age of 63 years, ranging from 31 to 88 [s2]. The comparison is the clearest quantitative signal in the label, and it is a direct head-to-head against the older tracer surgeons have long relied on.

Safety to note

The label's central caution is allergy. Hypersensitivity reactions — including anaphylaxis, urticaria and deaths from anaphylaxis — have been reported after intravenous indocyanine green, and the drug is contraindicated in anyone with a known hypersensitivity to it [s2]. The label instructs that resuscitation personnel and equipment be on hand and that patients be monitored during use [s2]. The formulation also contains a small amount of sodium iodide, a point relevant to patients with iodide sensitivity [s2].

How to read it

For operating teams, the practical meaning is another supply of a familiar tool, in a pre-mixed form that removes a reconstitution step. The FILM result is a genuine efficacy signal, but it was generated with an earlier indocyanine green formulation, and it speaks to one procedure — cervical and uterine cancer node mapping — not to every use the broad label permits. The dye shows where structures are; it does not by itself tell a surgeon what the tissue is, which is why excised nodes are still confirmed under the microscope.

This article describes a regulatory approval and is not medical advice. Decisions about surgical imaging are for clinicians and their patients. Patients with a history of reactions to indocyanine green or to iodide products should tell their surgical team before any procedure that uses the dye.

Sources

• Drugs@FDA: Zyogreen (indocyanine green), NDA 218579 — approval record — U.S. Food and Drug Administration, approved 10 July 2026
• Zyogreen (indocyanine green injection) — US prescribing information — U.S. Food and Drug Administration, label effective 16 July 2026