{"id":62035,"date":"2025-10-17T04:04:30","date_gmt":"2025-10-17T02:04:30","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/dompes-program-in-naion-selected-for-landmark-fda-commissioners-national-priority-voucher-program\/"},"modified":"2025-10-17T04:04:30","modified_gmt":"2025-10-17T02:04:30","slug":"dompes-program-in-naion-selected-for-landmark-fda-commissioners-national-priority-voucher-program","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/dompes-program-in-naion-selected-for-landmark-fda-commissioners-national-priority-voucher-program\/","title":{"rendered":"Domp\u00e9&#8217;s Program in NAION Selected for Landmark FDA Commissioner\u2019s National Priority Voucher Program"},"content":{"rendered":"<div>\n<ul class=\"bwlistsquare\">\n<li>\n<i>One of just nine voucher recipients chosen and the only one in the eye space, the selection spotlights Domp\u00e9\u2019s dedication to accelerate innovation and deliver breakthrough therapies to patients who urgently need them.<\/i><\/li>\n<li>\n<i>With this selection, Domp\u00e9 receives a voucher shortening the marketing application review from the standard 10\u201312 months to just 1\u20132 months.<\/i><\/li>\n<li>\n<i>Domp\u00e9 plans to apply the voucher to its Biologics License Application (BLA) for an intranasal form of Nerve Growth Factor (Cenegermin-bkbj) for the treatment of non-arteritic anterior ischemic optic neuropathy (NAION).<\/i><\/li>\n<li>\n<i>Domp\u00e9\u2019s intranasal NGF platform builds on the Nobel Prize-winning discovery of neurobiologist Professor Rita Levi-Montalcini and biochemist Dr. Stanley Cohen.<\/i><\/li>\n<\/ul>\n<p>MILAN &amp; SAN MATEO, Calif.&#8211;(BUSINESS WIRE)&#8211;Domp\u00e9, a leading biopharmaceutical company with operations in Italy and the US, announced today its selection by the United States Food and Drug Administration (FDA) to participate in the <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fnews-events%2Fpress-announcements%2Ffda-awards-first-ever-national-priority-vouchers-nine-sponsors&amp;esheet=54340762&amp;newsitemid=20251016094029&amp;lan=en-US&amp;anchor=Commissioner%26%238217%3Bs+National+Priority+Voucher+%28CNPV%29+program&amp;index=1&amp;md5=3d958db5c8caf70e0fb69c7fb10ba38d\" rel=\"nofollow\" shape=\"rect\">Commissioner\u2019s National Priority Voucher (CNPV) program<\/a>. Because of its selection, Domp\u00e9 has been awarded a voucher granting a significantly shortened review timeline for marketing application and enhanced collaboration with the FDA. Domp\u00e9 intends to apply the voucher for the Biologic License Application (BLA) for an intranasally administered formulation of Nerve Growth Factor (<i>Cenegermin-bkbj<\/i>) for the treatment of non-arteritic anterior ischemic optic neuropathy (NAION). The intranasal administration of NGF is a novel approach, patented by Domp\u00e9, offering a non-invasive delivery method.<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20251016094029\/en\/2612787\/5\/Logo_Domp%C3%A9_farmaceutici.png.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20251016094029\/en\/2612787\/22\/Logo_Domp%C3%A9_farmaceutici.png.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20251016094029\/en\/2612787\/5\/Logo_Domp%C3%A9_farmaceutici.png.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20251016094029\/en\/2612787\/21\/Logo_Domp%C3%A9_farmaceutici.png.jpg\"><\/a><\/p>\n<p>\n\u201cThe CNPV represents a strategic lever to accelerate access to transformative therapies for patients with unmet medical needs as NAION,\u201d said Sergio Domp\u00e9, Executive President at Domp\u00e9. \u201cBuilding on our pioneering achievement with Oxervate\u2014the first NGF-based therapy approved for Neurotrophic Keratitis in 2018\u2014we are now advancing a novel, intranasal formulation of NGF (<i>Cenegermin-bkbj)<\/i>, to bypass the blood-brain barrier and redefine possibilities in neuro-ophthalmology.\u201d<\/p>\n<p>\nNAION refers to a loss of blood flow to the optic nerve which causes sudden vision loss, that usually occurs spontaneously. There are approximately 6,000 new cases in the United States per year, and the number of cases is growing because of the aging population and rising prevalence of risk factors such as diabetes, hypertension, and other obesity-related conditions like sleep apnea. As many as three out of four patients experience substantial visual impairment, and approximately one in 10 patients experience profound loss of vision and legal blindness.<sup>1<\/sup><\/p>\n<p>\nThere are currently no approved treatments to reverse vision loss or prevent worsening in patients with NAION.<\/p>\n<p>\n\u201cNAION, strongly associated with obesity, cardiovascular disease and an aging population, is the most common acute optic neuropathy in people over 50 and can lead to severe, permanent vision loss,\u201d said Ahmed Enayetallah, Chief Development Officer at Domp\u00e9. \u201cGiven this unmet need, we are thrilled by the opportunity to expedite its development and bring potential solutions to patients sooner through the CNPV voucher.&#8221;<\/p>\n<p>\nDomp\u00e9 is developing intranasal NGF with aims of preserving and improving visual function in patients with vision loss secondary to NAION. A registrational pivotal trial program is planned in more than 130 sites across 16 countries.<\/p>\n<p>\n<b>About Domp\u00e9<br \/>\n<br \/><\/b>Domp\u00e9 farmaceutici S.p.A. is a privately held, global biopharmaceutical company on a mission to bring the full potential of nerve growth factor (NGF) to patients. As the first company to unlock the therapeutic potential of NGF, Domp\u00e9 developed the first FDA-approved NGF treatment. Today, our clinical pipeline reflects our commitment to redefining treatments across ophthalmic, neurological and pain-related conditions. Building on 130 years of independence, we are embracing the challenge to transform our science and ourselves by delivering first-in-class, disease-modifying therapies through NGF and other breakthrough molecules to help people improve their sight, support neurological recovery and manage pain effectively. Today, Domp\u00e9 employs more than 950 employees worldwide and maintains a US commercial operations hub in the San Francisco Bay Area.<\/p>\n<p>\nLearn more at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.dompe.com%2Fus%2F&amp;esheet=54340762&amp;newsitemid=20251016094029&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.dompe.com%2Fus%2F&amp;index=2&amp;md5=fefc2ab0fd313245f53bf8d967687211\" rel=\"nofollow\" shape=\"rect\">https:\/\/www.dompe.com\/us\/<\/a>.<\/p>\n<p>\n<b>About Nerve Growth Factor (NGF)<br \/>\n<br \/><\/b>Nerve Growth Factor (NGF) is a neurotrophin, a member of a family of proteins essential for the growth, maintenance and survival of neurons, with broad therapeutic potential. NGF was discovered by the Italian neurobiologist Professor Rita Levi-Montalcini and American biochemist Dr. Stanley Cohen, earning them the Nobel Prize in Physiology or Medicine in 1986. In their research, Drs. Levi-Montalcini and Cohen uncovered that NGF plays a crucial role in the proliferation, differentiation and survival of sympathetic and sensory neurons. Domp\u00e9 is the first company to unlock the therapeutic potential of NGF, building upon a Nobel Prize-winning discovery to deliver a breakthrough treatment for a rare neurotrophic eye disease.\u200b<\/p>\n<p>\n<b>About Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)<br \/>\n<br \/><\/b>Optic neuropathies are disorders caused by damage to the optic nerve, disrupting visual signals from the retina to the brain due to injury, inflammation, poor blood flow, or genetic and degenerative factors. The result is progressive or sudden loss of vision, often affecting central or peripheral sight, color discrimination, and in severe cases, leading to permanent blindness. Non-arteritic anterior ischemic optic neuropathy (NAION) is the most common cause of acute optic nerve injury and optic neuropathy in people over 50. It affects men and women equally, usually starting around age 66. While the exact cause isn\u2019t fully understood, common risk factors include diabetes, high blood pressure, high cholesterol, and smoking. Despite its frequency, and risk of severe permanent vision loss, there is no proven treatment to improve visual outcomes.<\/p>\n<p>\n<b>About the Commissioner&#8217;s National Priority Voucher (CNPV) Pilot Program<br \/>\n<br \/><\/b>The U.S. Food and Drug Administration (FDA) launched the Commissioner\u2019s National Priority Voucher (CNPV) pilot program to accelerate the development and review of prescription drugs and biological products that address critical U.S. national health priorities. Announced in June 2025, the program offers companies the opportunity to reduce standard application review times from 10\u201312 months to just 1\u20132 months through a collaborative, multidisciplinary review process.<\/p>\n<p>\nSelected companies receive a voucher that provides enhanced communication with the FDA and a rolling review to facilitate a faster timeline, while maintaining the agency\u2019s rigorous standards for safety and efficacy. The program focuses on transformative therapies that tackle major public health challenges and large unmet medical needs.<\/p>\n<p>\n<b>About Oxervate<br \/>\n<br \/><\/b>OXERVATE<sup>\u00ae<\/sup> (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis. <span class=\"bwuline\">Important Safety Information:<\/span> Contact lenses, either therapeutic or corrective, should be removed before applying OXERVATE. Contact lenses may be reinserted 15 minutes after OXERVATE administration. Eye Discomfort, such as eye pain, that can be mild to moderate can occur with OXERVATE. Patients should contact their health care provider if a more serious eye reaction occurs. The most common adverse reaction with OXERVATE (~16%) was eye pain. Other adverse reactions with OXERVATE (1% to 10%) included corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation, photophobia, tearing, and headache.<\/p>\n<p>\n<b>References:<\/b><\/p>\n<ol class=\"bwlistdecimal\">\n<li>\nDattilo M, et al. <i>Neuroophthalmology<\/i>. 2020;45(1):23-28.<\/li>\n<\/ol>\n<p>\n\u00a0<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Media Contact:<\/b><br \/>Charlie Gould \u2013 Ruder Finn<br \/>\n<br \/>+1 917 626 7968 \/ <a target=\"_blank\" href=\"mai&#108;&#116;&#111;&#58;&#x43;&#x68;&#x61;&#x72;&#x6c;&#x69;&#x65;&#46;Go&#117;&#108;&#100;&#64;&#114;&#x75;&#x64;&#x65;&#x72;&#x66;&#x69;nn&#46;c&#111;&#109;\" rel=\"nofollow\" shape=\"rect\">&#x43;h&#x61;&#114;&#x6c;&#105;&#x65;&#x2e;G&#x6f;&#117;&#x6c;&#100;&#x40;&#114;u&#x64;&#101;&#x72;&#102;&#x69;&#110;n&#x2e;&#99;&#x6f;&#109;<\/a><\/p>\n<p>\nGuido Romeo &#8211; Director Corporate Communications and Public Affairs<br \/>\n<br \/>+39 349 4154010 \/ <a target=\"_blank\" href=\"&#x6d;&#97;&#105;l&#x74;&#x6f;&#58;g&#x75;&#x69;&#100;o&#x2e;&#x72;&#111;m&#x65;&#x6f;&#64;d&#x6f;&#x6d;&#112;e&#x2e;&#x63;&#111;&#109;\" rel=\"nofollow\" shape=\"rect\">&#103;&#117;&#x69;d&#111;&#x2e;&#x72;o&#109;&#x65;&#x6f;&#64;&#100;&#x6f;m&#112;&#x65;&#x2e;c&#111;&#x6d;<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>One of just nine voucher recipients chosen and the only one in the eye space, the selection spotlights Domp\u00e9\u2019s dedication to accelerate innovation and deliver breakthrough therapies to patients who urgently need them. With this selection, Domp\u00e9 receives a voucher shortening the marketing application review from the standard 10\u201312 months to just 1\u20132 months. Domp\u00e9 &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/dompes-program-in-naion-selected-for-landmark-fda-commissioners-national-priority-voucher-program\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-62035","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Domp\u00e9&#039;s Program in NAION Selected for Landmark FDA Commissioner\u2019s National Priority Voucher Program - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/dompes-program-in-naion-selected-for-landmark-fda-commissioners-national-priority-voucher-program\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Domp\u00e9&#039;s Program in NAION Selected for Landmark FDA Commissioner\u2019s National Priority Voucher Program - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"One of just nine voucher recipients chosen and the only one in the eye space, the selection spotlights Domp\u00e9\u2019s dedication to accelerate innovation and deliver breakthrough therapies to patients who urgently need them. 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With this selection, Domp\u00e9 receives a voucher shortening the marketing application review from the standard 10\u201312 months to just 1\u20132 months. Domp\u00e9 ... 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