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Patient supportEnrollment journey

Getting started with customized support can be simple

Every person is different and so are your needs and preferences as a patient. That’s why Spark Therapeutics Generation Patient Services® is not a one-size-fits-all program.

Tailor patient support services to what works best for you:

  • Access support by phone, email, or meeting in-person
  • Take advantage of our program throughout your treatment journey
  • Share support information and resources with your caregiver

How to enroll

First, talk to your doctor and start the process to determine if LUXTURNA® (voretigene neparvovec-rzyl) may be right for you. The prescription gene therapy is for patients with an inherited retinal disease due to mutations in both copies of the RPE65 gene. Genetic testing is the only way to confirm this gene mutation. You must also have enough remaining cells in your retina (the thin layer of tissue in the back of your eyes) as determined by your healthcare professional at the time of consultation. If you have not had a genetic test, learn more here.

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1Mutations in both copies of the RPE65 gene

You have been genetically tested and have mutations in both copies of the RPE65 gene. Have you been connected with an ocular gene therapy treatment center?

YesNo

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2Fill out enrollment form

Completing and submitting this form in its entirety allows Spark® Therapeutics to enroll you in the program and investigate insurance.

Download enrollment form

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3Schedule a consultation

Your team will provide information and options to help you and your healthcare provider choose an ocular gene therapy treatment center for consultation. See a list of the available treatment centers.

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4Begin treatment

After you complete your enrollment form and choose your ocular gene therapy treatment center, we will help you navigate your treatment journey.

Start enrollment

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Participation in Spark Therapeutics Generation Patient Services® is voluntary and is not required to get treatment with LUXTURNA®. You may choose to participate in all, some, or none of the services offered. Participating or deciding not to participate in these services will have no effect on your ability to get treatment or the nature of your treatment or care. Spark Therapeutics Generation Patient Services does not provide medical advice. You should always rely on the direction of your healthcare professional for treatment and care.

US Full Prescribing Information

IMPORTANT SAFETY INFORMATION FOR LUXTURNA® (voretigene neparvovec-rzyl)

The following serious side effects may occur during or after the administration of LUXTURNA:

  • Eye infections, including a serious infection inside of the eye called endophthalmitis, that may lead to blindness.
  • Permanent decline in visual acuity, or the sharpness of central vision.
  • Changes in the retina (the thin layer of tissue in the back of the eye) that can lead to vision loss including:
    • development of a hole, thinning, or loss of function of the retina, separation of the layers in the center of the retina, loss of retinal cells and the choroid (the layer of blood vessels that lines the back of the eye), or bleeding in the retina.
    • breaks in or wrinkling on the surface of the retina or detachment of the retina.
  • Increased pressure inside of the eye. You should follow-up with your healthcare professional as instructed to detect and treat any increased pressure in the eye as this may cause blindness.
  • Expansion of the air bubble formed in the eye after administration of LUXTURNA. You should avoid air travel, travel to high elevations, or scuba diving until your healthcare professional has told you that the air bubble formed in the eye following administration of LUXTURNA has disappeared. Engaging in these activities while the air bubble is present can cause permanent vision loss.
  • Formation or worsening of cataract (clouding of the lens inside of the eye).

Tell your healthcare professional right away if you have any of the following symptoms of these serious side effects:

  • Seeing floaters (specks that float about in your field of vision)
  • Pain in the eye
  • Any change in vision including decreased vision or blurred vision
  • Seeing flashes of light

The following are the most common side effects that may occur with LUXTURNA:

  • Redness of the eye
  • Cataract (clouding of the lens inside of the eye)
  • Increased pressure inside of the eye
  • Breaks in the retina
  • Dellen (thinning of the clear layer in the front of the eye)
  • Development of a hole in the center of the retina
  • Subretinal deposits (deposits under the retina)
  • Eye swelling, irritation or pain
  • Wrinkling on the surface of the center of the retina

Treatment with LUXTURNA is not recommended for patients younger than 12 months of age because the retina is still growing, which may affect how LUXTURNA works.

Because small quantities of LUXTURNA may be in your tears for a short period of time, for the first 7 days after administration of LUXTURNA, place any waste material from dressings, tears and nasal secretions in sealed bags prior to disposal.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Spark® Therapeutics at 1-855-SPARKTX (1-855-772-7589).

This information does not take the place of talking to your healthcare professional about your medical condition or treatment. If you have questions about LUXTURNA after reading this information, ask your healthcare professional.

Please see the US Full Prescribing Information for LUXTURNA.

INDICATION

LUXTURNA (voretigene neparvovec-rzyl) is a prescription gene therapy product used for the treatment of patients with inherited retinal disease due to mutations in both copies of the RPE65 gene, which can only be confirmed through genetic testing.

You must also have enough remaining cells in your retina (the thin layer of tissue in the back of your eyes) as determined by your healthcare professional.

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