HCP supportHCP resources

Brochures and forms

Referring physician guide

This guide provides support for your practice with the patient consultation process for LUXTURNA® (voretigene neparvovec-rzyl).

Download PDF

Enrollment form

Use this form to enroll your patients in the Spark Therapeutics Generation Patient ServicesSM program. It also allows Generation Patient Services to look into the patient’s insurance and next steps for treatment. Make sure to have the patient complete and include the patient authorization.

Download PDF

Statement of Medical Necessity

This form is completed by the ocular gene therapy treatment center when a patient has had a consultation and meets the eligibility requirements for LUXTURNA. This form allows Spark® Therapeutics to start a benefits investigation. It also enrolls a patient in Spark Therapeutics Generation Patient Services if the patient is not yet enrolled. Make sure to have the patient complete and include the patient authorization.

Download PDF

LUXTURNA (voretigene neparvovec-rzyl) reimbursement guide for ocular gene therapy treatment centers

This guide provides information to your ocular gene therapy treatment center to help facilitate the LUXTURNA reimbursement process.

Download PDF

Mentee brochure

Learn more about eligibility and how to get your patients started with a mentor.

Download PDF

Navigating insurance and accessing financial assistance resources can be less stressful when your patients have people on their side. Spark Therapeutics may be able to connect with your patient regarding financial resources.

Learn more

Ocular gene therapy treatment centers

LUXTURNA is only administered at ocular gene therapy treatment centers. Spark Therapeutics has designated these select ocular gene therapy treatment centers to support patient care with a staff of healthcare professionals, including retinal specialists, nurses, and genetic counselors, who have experience treating patients with inherited retinal diseases (IRDs).

Learn more about LUXTURNA

Alkek Eye Center, Baylor College of Medicine Jamail Specialty Care Center

Houston, TX 77030

Bascom Palmer Eye Institute, University of Miami Health System

Miami, FL 33136

Boston Children’s Hospital

Boston, MA 02115

Children’s Hospital of Philadelphia

Philadelphia, PA 19104

Cincinnati Children’s Hospital

Cincinnati, OH 45229

Kellogg Eye Center, University of Michigan

Ann Arbor, MI 48105

Massachusetts Eye and Ear

Boston, MA 02114

OHSU Casey Eye Institute

Portland, OR 97239

Scheie Eye Institute Penn Presbyterian

Philadelphia, PA 19104

UAB Callahan Eye

Birmingham, AL 35233

University of Iowa Hospitals and Clinics

Iowa City, IA 52242

UPMC Eye Center

Pittsburgh, PA 15213

University of Rochester Medical Center, Flaum Eye Institute

Rochester, NY 14642

The Vision Center at Children’s Hospital Los Angeles

Los Angeles, CA 90027

IMPORTANT SAFETY INFORMATION FOR LUXTURNA (voretigene neparvovec-rzyl)

Warnings and Precautions

  • Endophthalmitis may occur following any intraocular surgical procedure or injection. Use proper aseptic injection technique when administering LUXTURNA, and monitor for and advise patients to report any signs or symptoms of infection or inflammation to permit early treatment of any infection.
  • Permanent decline in visual acuity may occur following subretinal injection of LUXTURNA. Monitor patients for visual disturbances.
  • Retinal abnormalities may occur during or following the subretinal injection of LUXTURNA, including macular holes, foveal thinning, loss of foveal function, foveal dehiscence, chorioretinal atrophy, and retinal hemorrhage. Monitor and manage these retinal abnormalities appropriately. Do not administer LUXTURNA in the immediate vicinity of the fovea. Retinal abnormalities may occur during or following vitrectomy, including retinal tears, epiretinal membrane, or retinal detachment. Monitor patients during and following the injection to permit early treatment of these retinal abnormalities. Advise patients to report any signs or symptoms of retinal tears and/or detachment without delay.
  • Increased intraocular pressure may occur after subretinal injection of LUXTURNA. Monitor and manage intraocular pressure appropriately.
  • Expansion of intraocular air bubbles Instruct patients to avoid air travel, travel to high elevations or scuba diving until the air bubble formed following administration of LUXTURNA has completely dissipated from the eye. It may take one week or more following injection for the air bubble to dissipate. A change in altitude while the air bubble is still present can result in irreversible vision loss. Verify the dissipation of the air bubble through ophthalmic examination.
  • Cataract Subretinal injection of LUXTURNA, especially vitrectomy surgery, is associated with an increased incidence of cataract development and/or progression.

Adverse Reactions

  • In clinical studies, ocular adverse reactions occurred in 66% of study participants (57% of injected eyes), and may have been related to LUXTURNA, the subretinal injection procedure, the concomitant use of corticosteroids, or a combination of these procedures and products.
  • The most common adverse reactions (incidence ≥ 5% of study participants) were conjunctival hyperemia (22%), cataract (20%), increased intraocular pressure (15%), retinal tear (10%), dellen (thinning of the corneal stroma) (7%), macular hole (7%), subretinal deposits (7%), eye inflammation (5%), eye irritation (5%), eye pain (5%), and maculopathy (wrinkling on the surface of the macula) (5%).

Immunogenicity

Immune reactions and extra-ocular exposure to LUXTURNA in clinical studies were mild. No clinically significant cytotoxic T-cell response to either AAV2 or RPE65 has been observed. In clinical studies, the interval between the subretinal injections into the two eyes ranged from 7 to 14 days and 1.7 to 4.6 years. Study participants received systemic corticosteroids before and after subretinal injection of LUXTURNA to each eye, which may have decreased the potential immune reaction to either AAV2 or RPE65.

Pediatric Use

Treatment with LUXTURNA is not recommended for patients younger than 12 months of age, because the retinal cells are still undergoing cell proliferation, and LUXTURNA would potentially be diluted or lost during the cell proliferation. The safety and efficacy of LUXTURNA have been established in pediatric patients. There were no significant differences in safety between the different age subgroups.

Please see the US Full Prescribing Information for LUXTURNA.

INDICATION

LUXTURNA (voretigene neparvovec-rzyl) is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.

Patients must have viable retinal cells as determined by the treating physicians.

Show more

Accessibility policy

Throughout the creation of this website, we followed accessibility guidelines established by the World Wide Web Consortium (W3C®), an international group that develops website standards. Sites that don’t meet these guidelines can be challenging, or even unusable, for people with low vision. To avoid that possibility, we relied on W3C principles to guide each step, and to make this site accessible to all of our visitors.

Adjust the setting of the site for easier reading.

HIGH CONTRAST
Font size
AA
Line height