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ABOUT LUXTURNA®Ocular gene therapy treatment centers

Each treatment center is staffed with healthcare professionals, including retinal specialists, nurses, and genetic counselors, who have experience caring for patients with inherited retinal diseases.

LUXTURNA is only administered at Ocular Gene Therapy Treatment Centers

Spark Therapeutics has designated select treatment centers to help support the appropriate use of LUXTURNA, from storing and handling to administration. In addition to regular appointments with your patient, you may continue to play an active role after referring your patient to a treatment center.

Some considerations for treatment center participation includes:

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Specialized scientific or clinical experience relevant to the administration of LUXTURNA

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A commitment to pharmacy and surgical education regarding LUXTURNA administration

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The ability to properly receive, store, and handle LUXTURNA

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The option to coordinate and manage patient logistics with our Spark Therapeutics Generation Patient ServicesSM team*

*Participation in Spark Therapeutics Generation Patient ServicesSM is voluntary. Your patient 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 patient’s ability to get treatment or the nature of your patient’s treatment or care. Generation Patient Services does not provide medical advice.

With locations across the United States, it is easy for your patients to find a designated LUXTURNA treatment center

Alkek Eye Center, Baylor College of Medicine Jamail Specialty Care CenterHouston, TX 77030
Bascom Palmer Eye Institute, University of Miami Health SystemMiami, FL 33136
Boston Children’s HospitalBoston, MA 02115
Children’s Hospital of PhiladelphiaPhiladelphia, PA 19104
Cincinnati Children’s HospitalCincinnati, OH 45229
Kellogg Eye Center, University of MichiganAnn Arbor, MI 48105
Massachusetts Eye and EarBoston, MA 02114
OHSU Casey Eye InstitutePortland, OR 97239
Scheie Eye Institute Penn PresbyterianPhiladelphia, PA 19104
UAB Callahan EyeBirmingham, AL 35233
University of Iowa Hospitals and ClinicsIowa City, IA 52242
University of Rochester Medical Center, Flaum Eye InstituteRochester, NY 14642
University of Pittsburgh Medical Center (UPMC)Pittsburgh, PA 15261
The Vision Center at Children’s Hospital Los AngelesLos Angeles, CA 90027

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IMPORTANT SAFETY INFORMATION FOR LUXTURNA

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, 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.