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It is a one-time gene therapy that has the potential to restore the visual cycle鈥攖he process that allows you to see.</p> </div> </div> <div class="wp-block-group alignfull has-chalk-background-color has-background is-layout-constrained wp-block-group-is-layout-constrained"><div id="who-luxturna-is-for" data-block_1b96ba8bc0d66d5eae92406103e1520e class="section-heading alignwide not-prose" > <h2 class="text-aqua font-semibold font-sans-alt text-[2.375rem] leading-[2.625rem] mt-16 after:content-[' '] after:block after:h-2 after:bg-gradient-to-r after:from-teal after:to-fern after:max-w-[13.375rem] after:my-8""> Who LUXTURNA is for </h2> </div> <div data-block_4ee8d66f8c12502315d9881cda4669a3 class="body alignwide mb-8 lg:mb-14" > <div class="xl:pr-8 prose-xl prose-body prose-ol-nested-list-circle prose-ol:pl-[1em] prose-ul:pl-[1em] prose-ol:my-0 prose-ul:my-0 lg:prose-ol:pl-[1em] lg:prose-ul:pl-[1em] lg:prose-ol:my-0 lg:prose-ul:my-0 prose-li:my-0 lg:prose-li:my-0 prose-li:pl-0 lg:prose-li:pl-0" > <p>LUXTURNA is used for the treatment of patients who have both of the following:</p> <ul> <li>An inherited retinal disease (IRD) due to mutations in both copies of the <em>RPE65</em> gene</li> <li>Enough remaining cells in their retina as determined by a healthcare professional</li> </ul> <h3><em>RPE65</em> is a gene that is necessary to make a protein needed for vision</h3> <p><em> RPE65</em> gene mutations cause vision to deteriorate and may progress to complete blindness.</p> </div> </div> <div data-block_b19368b2992ae67c2af411483b13a031 class="symptoms aligncenter not-prose mb-14" > <div class="max-w-[39rem] mx-auto"> <h3 class="text-[1.625rem] leading-8 mb-4"> If you have mutations in both copies of the <em>RPE65</em> gene, you may experience: </h3> <ul class="flex flex-col overflow-hidden"> <li class="flex items-center justify-start w-full border-b border-aqua py-5 text-xl font-semibold -mb-px"> <span class="flex justify-start items-center w-20 flex-shrink-0 px-2"> <img loading="lazy" decoding="async" src="https://luxturna.com/uploads/2022/12/symptom-night-blindness.png?height=300&width=300" class="block self-center object-center object-contain h-10 w-10 flex-shrink-0" alt="" /> </span> <span> Night blindness (nyctalopia) </span> </li> <li class="flex items-center justify-start w-full border-b border-aqua py-5 text-xl font-semibold -mb-px"> <span class="flex justify-start items-center w-20 flex-shrink-0 px-2"> <img loading="lazy" decoding="async" src="https://luxturna.com/uploads/2022/12/symptom-loss-of-sensitivity.png?height=300&width=300" class="block self-center object-center object-contain h-10 w-10 flex-shrink-0" alt="" /> </span> <span> Loss of light sensitivity </span> </li> <li class="flex items-center justify-start w-full border-b border-aqua py-5 text-xl font-semibold -mb-px"> <span class="flex justify-start items-center w-20 flex-shrink-0 px-2"> <img loading="lazy" decoding="async" src="https://luxturna.com/uploads/2022/12/symptom-loss-of-sharpness.png?height=300&width=300" class="block self-center object-center object-contain h-10 w-10 flex-shrink-0" alt="" /> </span> <span> Loss of sharpness or clarity of vision </span> </li> <li class="flex items-center justify-start w-full border-b border-aqua py-5 text-xl font-semibold -mb-px"> <span class="flex justify-start items-center w-20 flex-shrink-0 px-2"> <img loading="lazy" decoding="async" src="https://luxturna.com/uploads/2022/12/symptom-impaired-adaptation.png?height=300&width=300" class="block self-center object-center object-contain h-10 w-10 flex-shrink-0" alt="" /> </span> <span> Impaired dark adaptation </span> </li> <li class="flex items-center justify-start w-full border-b border-aqua py-5 text-xl font-semibold -mb-px"> <span class="flex justify-start items-center w-20 flex-shrink-0 px-2"> <img loading="lazy" decoding="async" src="https://luxturna.com/uploads/2022/12/symptom-uncontrolled-movements.png?height=300&width=300" class="block self-center object-center object-contain h-10 w-10 flex-shrink-0" alt="" /> </span> <span> Repetitive uncontrolled movements of the eye (nystagmus) </span> </li> </ul> </div> </div> </div> <div id="irds-and-rpe65" data-block_4e30c56f13054339f2fa43d60fd796a3 class="section-heading alignwide not-prose" > <h2 class="text-aqua font-semibold font-sans-alt text-[2.375rem] leading-[2.625rem] mt-16 after:content-[' '] after:block after:h-2 after:bg-gradient-to-r after:from-teal after:to-fern after:max-w-[13.375rem] after:my-8""> IRDs and <em>RPE65</em> </h2> </div> <div data-block_772c9b3b383b32afbf62d145d3db01d6 class="body alignwide mb-8 lg:mb-14" > <div class="xl:pr-8 prose-xl prose-body prose-ol-nested-list-circle prose-ol:pl-[1em] prose-ul:pl-[1em] prose-ol:my-0 prose-ul:my-0 lg:prose-ol:pl-[1em] lg:prose-ul:pl-[1em] lg:prose-ol:my-0 lg:prose-ul:my-0 prose-li:my-0 lg:prose-li:my-0 prose-li:pl-0 lg:prose-li:pl-0" > <p>A gene is the basic unit of hereditary information that is passed on to a child from their parents. Typically, every person has two copies of a gene, one from each parent. In the case of IRDs due to <em>RPE65</em> gene mutations, both of the genes passed onto the child are mutated.</p> </div> </div> <figure class="wp-block-image size-full is-resized is-style-gradient-border"><a href="https://prod-wp.luxturna.com/wp-content/uploads/2022/12/updated-graphic-scaled.jpg"><img loading="lazy" decoding="async" src="https://prod-wp.luxturna.com/wp-content/uploads/2022/12/updated-graphic-scaled.jpg" alt="" class="wp-image-612" width="1005" height="651" srcset="https://luxturna.com/uploads/2022/12/updated-graphic-scaled.jpg?width=2560 2560w, https://luxturna.com/uploads/2022/12/updated-graphic-scaled.jpg?height=195&width=300&cropped 300w, https://luxturna.com/uploads/2022/12/updated-graphic-scaled.jpg?height=664&width=1024&cropped 1024w, https://luxturna.com/uploads/2022/12/updated-graphic-scaled.jpg?height=498&width=768&cropped 768w, https://luxturna.com/uploads/2022/12/updated-graphic-scaled.jpg?height=996&width=1536&cropped 1536w, https://luxturna.com/uploads/2022/12/updated-graphic-scaled.jpg?height=1328&width=2048&cropped 2048w" sizes="(max-width: 1005px) 100vw, 1005px" /></a></figure> <div data-block_cef2b1a3f79f24f85ba2724e3a160c32 class="body alignwide mb-8 lg:mb-14" > <div class="xl:pr-8 prose-xl prose-body prose-ol-nested-list-circle prose-ol:pl-[1em] prose-ul:pl-[1em] prose-ol:my-0 prose-ul:my-0 lg:prose-ol:pl-[1em] lg:prose-ul:pl-[1em] lg:prose-ol:my-0 lg:prose-ul:my-0 prose-li:my-0 lg:prose-li:my-0 prose-li:pl-0 lg:prose-li:pl-0" > <h3>There are many IRDs</h3> <p>For example, Leber congenital amaurosis and retinitis pigmentosa are two types of IRDs. These are clinical diagnoses that are not based on mutations in specific genes, such as mutations in both copies of the <em>RPE65</em> gene. <em>RPE65</em> is one out of more than 270 genes that may be responsible for an IRD. Confirming your specific gene mutation or mutations with a genetic test is the first step to learning if LUXTURNA may be right for you.</p> </div> </div> <div data-block_07201ca787cbcf214e5292bbd06619e4 class="cta alignfull not-prose py-20 bg-aqua bg-center bg-repeat-y" style="background-image: url(https://luxturna.com/assets/40d70543ac1a496474ecc8647ef351b7523c4981b14118096fe6a501451b494c/wp-content/themes/luxturna/public/images/scroll-layer.3d912e.png); background-size: 1168px auto;" > <div class="mx-auto flex flex-col justify-center items-center px-9 md:flex-row md:px-4 max-w-[46rem]"> <h2 class="text-2xl leading-7 text-white font-semibold text-center md:text-left"> Empower and inform your decision making with a genetic diagnosis </h2> <a class="inline-block cursor-pointer text-xl font-bold text-center rounded-full px-6 py-4 min-w-[13.125rem] transition-colors duration-300 ease-in-out bg-white text-aqua hover:bg-chalk hover:text-charcoal flex-shrink-0 self-center mt-8 md:ml-6 md:my-auto" href="https://www.eyewant2know.com/" target="_blank""> Go now </a> </div> </div> <div id="gene-therapy-overview" data-block_0c5effd2a6f64d74360db97f88007c38 class="section-heading alignwide not-prose" > <h2 class="text-aqua font-semibold font-sans-alt text-[2.375rem] leading-[2.625rem] mt-16 after:content-[' '] after:block after:h-2 after:bg-gradient-to-r after:from-teal after:to-fern after:max-w-[13.375rem] after:my-8""> Gene therapy overview </h2> </div> <div data-block_aeed26e44e2072c466566e6c48c67812 class="body alignwide mb-8 lg:mb-14" > <div class="xl:pr-8 prose-xl prose-body prose-ol-nested-list-circle prose-ol:pl-[1em] prose-ul:pl-[1em] prose-ol:my-0 prose-ul:my-0 lg:prose-ol:pl-[1em] lg:prose-ul:pl-[1em] lg:prose-ol:my-0 lg:prose-ul:my-0 prose-li:my-0 lg:prose-li:my-0 prose-li:pl-0 lg:prose-li:pl-0" > <p>Gene therapy has the potential to enable treatment of complex diseases. Several innovators behind gene therapy research are targeting IRDs, making gene therapy a potential turning point for patients and caregivers in the IRD community.</p> </div> </div> <div data-block_0613c4c2e18b74a536fa4fd271203b4e class="page-link alignfull not-prose layout border-t border-gray flex justify-center items-center" > <a href="/how-does-luxturna-work/" target="" class="alignwide flex justify-center items-center text-aqua font-bold text-[1.375rem] leading-7 py-5 lg:py-8"> <span class="block"> Keep reading to see how LUXTURNA may improve functional vision </span> <img decoding="async" alt="Arrow icon" src="https://luxturna.com/assets/40d70543ac1a496474ecc8647ef351b7523c4981b14118096fe6a501451b494c/wp-content/themes/luxturna/public/images/icon-page-link.9953e4.svg" class="w-6 h-auto flex-shrink-0 self-center ml-4"> </a> </div> </main> <div id="important-safety-information" class="isi-info bg-white max-w-none marker:text-aqua before:content-[' '] before:block before:h-[5px] before:bg-gradient-to-r before:from-teal before:to-fern prose prose-xs lg:prose-xl prose-ol-nested-list-circle marker:text-aqua prose-h1:text-aqua prose-h2:text-aqua prose-h3:text-aqua prose-h1:uppercase prose-h2:uppercase prose-h3:uppercase prose-h4:uppercase prose-h5:uppercase prose-h6:uppercase prose-p:text-3xs prose-ol:text-3xs prose-ul:text-3xs prose-h1:text-base prose-h2:text-sm prose-h3:text-sm prose-h4:text-sm prose-h5:text-sm prose-h6:text-sm prose-h1:mb-[0.5em] prose-h2:mb-[0.5em] prose-h3:mb-[0.5em] prose-h4:mb-[0.5em] prose-h5:mb-[0.5em] prose-h6:mb-[0.5em] lg:prose-p:text-xl lg:prose-ol:text-xl lg:prose-ul:text-xl lg:prose-h1:text-3xl lg:prose-h2:text-[1.4375rem] lg:prose-h3:text-[1.4375rem] lg:prose-h4:text-[1.4375rem] lg:prose-h5:text-[1.4375rem] lg:prose-h6:text-[1.4375rem] prose-ol:pl-[1em] prose-ul:pl-[1em] prose-ol:my-0 prose-ul:my-0 lg:prose-ol:pl-[1em] lg:prose-ul:pl-[1em] lg:prose-ol:my-0 lg:prose-ul:my-0 prose-li:my-0 lg:prose-li:my-0 prose-li:pl-0 lg:prose-li:pl-0" > <div class="isi-container relative max-w-[1440px] mx-auto px-9 pb-5"> <div class="lg:flex lg:gap-x-12"> <div class="prose-isi lg:order-2 lg:w-[26rem] lg:flex-shrink-0 lg:-mr-[0.6rem]"> <h2>Indication</h2> <p>LUXTURNA <span style="white-space: nowrap;">(voretigene neparvovec-rzyl)</span> is a prescription gene therapy product used for the treatment of patients with inherited retinal disease due to mutations in both copies of the <em>RPE65</em> 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.</p> </div> <div class="prose-isi lg:order-1 lg:flex-grow"> <h2>Important Safety Information for LUXTURNA</h2> <p><strong>The following serious side effects may occur during or after the administration of LUXTURNA:</strong></p> <ul> <li>Eye infections, including a serious infection inside of the eye called endophthalmitis, that may lead to blindness.</li> <li>Permanent decline in visual acuity, or the sharpness of central vision.</li> <li>Changes in the retina (the thin layer of tissue in the back of the eye) that can lead to vision loss including: <ul> <li>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.</li> <li>breaks in or wrinkling on the surface of the retina or detachment of the retina.</li> </ul> </li> <li>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.</li> <li>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.</li> <li>Formation or worsening of cataract (clouding of the lens inside of the eye).</li> </ul> <p><strong>Tell your healthcare professional right away if you have any of the following symptoms of these serious side effects:</strong></p> <ul> <li>Seeing floaters (specks that float about in your field of vision)</li> <li>Pain in the eye</li> <li>Any change in vision including decreased vision or blurred vision</li> <li>Seeing flashes of light</li> </ul> <p><strong>The following are the most common side effects that may occur with LUXTURNA:</strong></p> <ul> <li>Redness of the eye</li> <li>Cataract (clouding of the lens inside of the eye)</li> <li>Increased pressure inside of the eye</li> <li>Breaks in the retina</li> <li>Dellen (thinning of the clear layer in the front of the eye)</li> <li>Development of a hole in the center of the retina</li> <li>Subretinal deposits (deposits under the retina)</li> <li>Eye swelling, irritation or pain</li> <li>Wrinkling on the surface of the center of the retina</li> </ul> <p>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.</p> <p>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.</p> <p>You are encouraged to report negative side effects of prescription drugs to the FDA. Visit <a href="https://www.fda.gov/medwatch" target="_blank" rel="noopener">www.fda.gov/medwatch</a>, or call <strong style="color: #00747b;">1-800-FDA-1088</strong>. You may also report side effects to Spark Therapeutics at <strong style="color: #00747b;">1-855-SPARKTX (1-855-772-7589)</strong>.</p> <p>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.</p> <p><strong style="color: #00747b;"><a href="https://sparktx.com/LUXTURNA_US_Prescribing_Information.pdf" target="_blank">Please see the US Full Prescribing Information</a> for LUXTURNA.</strong></p> </div> </div> </div> </div> <footer class="accessibility-info prose prose-sm bg-overcast max-w-none"> <div class="relative container mx-auto px-9 py-5 lg:px-4"> <p>Throughout the creation of this website, we followed accessibility guidelines established by the <a href="https://www.w3.org/" target="_blank" rel="noopener">World Wide Web Consortium (W3C<sup>庐</sup>)</a>, an international group that develops website standards. Sites that don鈥檛 meet these guidelines can be challenging, or even unusable, for people with low vision. 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