Luxturna Kit
Product Images NDC 71394-415

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Luxturna (NDC 71394-415). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Spark Therapeutics, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Figure 1. Syringe With 0.3 mL Luxturna (Lux 01)

An instructional illustration of a syringe indicating a 0.3 mL dose measurement. The syringe markings range from 0.1 to 1.0 mL, with a highlighted section showing the 0.3 mL volume to be drawn or administered.*

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Figure 2a. First Position Of The Operators During Preparation Of Luxturna Syringes (Lux 02)

Illustration showing two operators performing a task together. The primary operator is holding an object with both hands above a surface, while the secondary operator uses one hand beneath the surface. Both arms are gloved and the operators' roles are labeled.*

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Figure 2b. Second Position Of The Operators During Preparation Of Luxturna Syringes (Lux 03)

An instructional black and white line drawing showing hands wearing gloves using a syringe to withdraw 0.8 ml of liquid from a vial. The illustration demonstrates the proper technique for preparing an injectable dose, relevant to the LUXTURNA kit by Spark Therapeutics, Inc.*

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Figure 4. Volume Of Luxturna For Injection (Lux 05)

An illustration showing a syringe with measurement markings in milliliters (mL), highlighting the 0.3 mL level with arrows pointing to it. This indicates the volume to be measured or administered.*

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Figure 5a. Subretinal Injection Cannula Introduced Via Pars Plana (Lux 06)

An anatomical illustration showing an eye with a vitrectomy trocar and a subretinal injection cannula inserted. The diagram highlights the recommended injection area inside the eye, demonstrating a surgical approach for subretinal administration.*

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Figure 5b. Tip Of The Subretinal Injection Cannula Placed Within The Recommended Site Of Injection (surgeon’s Point Of View) (Lux 07)

An anatomical diagram of the eye's retina showing labeled directions (Inferior, Nasal, Superior, Temporal). A needle is depicted performing a subretinal injection in the recommended injection area, indicated by a dashed outline. The image illustrates the subretinal injection cannula placement for LUXTURNA (voretigene neparvovec-rzyl) administration.*

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Figure 6. Mlmt Score Using Both Eyes At Baseline And One Year For Individual Subjects (Lux 08)

A scatter plot chart showing MLMT (multi-luminance mobility testing) scores using both eyes, comparing baseline and year 1 scores across treatment and control groups. The y-axis lists individual subjects by ID and age, while the x-axis presents MLMT scores ranging from less than 1 to 8. The chart highlights changes in performance after one year for both groups.*

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Figure 7. Mlmt Time-course Over Two Years: Using Both Eyes (Lux 09)

A box plot graph showing MLMT score change using both eyes over study duration in days for LUXTURNA treatment and control/crossover treatment groups. The x-axis represents time from day 0 to 365 days post-treatment, while the y-axis measures MLMT score changes. Data is segmented into treatment, control/crossover, and marked time points with variability indicated by whiskers.*

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Principal Display Panel (Luxturna Diluent Label)

Label for diluent of voretigene neparvovec-rzyl showing NDC 71394-716-01, pH 7.3 with 0.001% poloxamer 188. Contains 1.7 mL per vial, storage instructions under -65°C, and manufacturer Spark Therapeutics, Inc. by Nova Laboratories. US License No. 2056 included.*

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Principal Display Panel (Luxturna Label)

Label for LUXTURNA, containing voretigene neparvovec-rzyl, a human prescription drug kit by Spark Therapeutics, Inc. The label displays NDC 71394-065-01, dosage details for subretinal injection, storage instructions at -65°C, and advises discarding unused portions. It also includes US license number 2056 and notes a single 0.5 mL dose per vial.*

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Principal Display Panel (Luxturna Carton Label)

Packaging label for LUXTURNA kit containing voretigene neparvovec-rzyl by Spark Therapeutics, Inc. The label includes the proprietary and generic names, NDC 71394-415, detailed vial information, directions for use, and barcodes for identification. It is designed as a foldable box with sections for vial placement and labeling.*

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Principal Display Panel (Luxturna Pouch Label)

Packaging label for LUXTURNA (voretigene neparvovec-rzyl) kit by Spark Therapeutics, Inc. The label indicates a single-dose vial of the drug and diluent vials with specific volumes, storage requirements at or below -65°C, and administration instructions by subretinal injection. The label includes barcodes, manufacturer address, and a note to see the package insert for full prescribing information.*

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Principal Display Panel (Luxturna Pouch Label)

Label for LUXTURNA (voretigene neparvovec-rzyl) kit by Spark Therapeutics, Inc. It includes dosage information of a single-dose vial and diluent vials with specified volumes. Storage instructions and administration route (subretinal injection) are noted. Manufacturer address and licensing details are present along with barcodes and 2D code.*

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Figure 3. Injection Apparatus Assembly (Lux04)

An instructional diagram showing the components of the LUXTURNA (voretigene neparvovec) kit, including a labeled syringe containing the medication, an extension tube, and a subretinal injection cannula, illustrating their connection and arrangement for administration.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.