Participants Needed for Galassia: New Investigational NAION Study

NAION is the most common acute optic neuropathy in people 50 years of age and older.^1,2 The damage to the optic nerve disrupts visual signals from the retina to the brain that result in rapid, monocular vision loss.³  

The annual incidence of NAION in the United States has been reported as 2.³ and 10.2 per 100,000 population in individuals ≥ 50 years of age,^1,2 with at least 6,000 new cases in the US each year.⁴ The mean age at NAION onset across multiple studies ranges from 61 to 70 years.^1,5-8 

Pathophysiology 

While the pathogenesis is not fully understood, NAION may occur when posterior ciliary artery perfusion to the optic nerve head (ONH) is disrupted.⁹ Reduced blood flow causes hypoxia and nutrient deficiency, which damages the optic nerve.⁹ 

ONH oedema can lead to characteristic optic disc oedema seen in NAION. Over time, this oedema may resolve leaving optic disc atrophy and visual field defects, which are hallmarks of the disease.⁹ 

Risk Factors and Comorbidities  

Risk factors and comorbidities include:^4,10 

• Crowded optic disc (disc-at-risk), 
• Systemic diseases (e.g., hypertension, diabetes, and hypercholesterolemia), 
• Nocturnal hypotension,  
• Obstructive sleep apnea, 
• Migraine, 
• Smoking, and 
• Medications (e.g., PDE-5i, amiodarone). 

Results of a retrospective observational study suggested an association between semaglutide and NAION.^‡11 

Subsequent studies evaluating a potential association have reported mixed findings, with some analyses suggesting an increased risk and others finding no association.^12-16 

Differential Diagnosis

Table 1. Differential diagnosis of NAION. Adapted from Salvetat ML, et al. Vision (Basel). 2023;7:72. Licensed under CC BY 4.0.9 Abbreviations: AAION (arteritic anterior ischemic optic neuropathy), C/D (cup-to-disc), NAION (non-arteritic anterior ischemic optic neuropathy).

Diagnosis of NAION is commonly based on clinical features including acute monocular painless visual loss, presence of relative afferent pupillary defect (RAPD), optic disc oedema, and peripapillary hemorrhage^.9,17 

Clinical Prognosis 

Visual loss is typically acute and stable, resulting in permanent vision loss in the majority of cases.^6,9 

While some experience improvement in visual acuity, visual field defects are less likely to improve.^6,10,18 

Recurrence in the same eye is rare, occurring in fewer than 5% of patients.¹⁷ 

Approximately 15% of patients with a disc-at-risk develop NAION in the fellow eye at five years.¹⁷ 

Glial scar formation and degeneration of axon fibers can occur within 14 days of the ischemic event, and therefore early treatment is critical for neuroprotection of retinal ganglion cells.^19,20,21 

The Galassia-NAION-301 Study 

Dompé farmaceutici S.p.A and partner investigators have initiated a new clinical trial in Australia to evaluate a potential treatment for NAION. The trial is being conducted at global clinical sites and is a randomised, multicentre, vehicle-controlled, double-masked study to evaluate the efficacy and safety of intranasal cenegermin (recombinant human nerve growth factor [rhNGF]) in adult participants with NAION. The study will target 272 patients with an onset of symptoms within 14 days. Participation will last six months, with two months of treatment period (five study visits) and four months of follow up (three study visits). Patients will be assigned to receive either cenegermin or the vehicle only (no treatment) in a 1:1 ratio.  

Key Trial Eligibility Criteria  

Patients may be eligible if they meet the following key criteria:   

• Gender and age: Women and men, 50 to 80 years of age,  
• Diagnosis: Confirmed clinical diagnosis of unilateral NAION in the study eye with symptom onset within the past 14 days,  
• Best corrected visual acuity score: in the study eye of ≥ 15 letters and ≤ 65 letters as measured by the ETDRS chart. 

Patients are not eligible if they meet the following key criteria:  

• Bilateral or sequential NAION with fellow eye involvement within six weeks of study eye involvement, 
• Intraocular pressure (IOP) > 25 mmHg OR history of glaucoma in the study eye,   
• Intermediate age-related macular degeneration (AMD) with subfoveal drusen, geographic atrophy, or exudative AMD in the study eye.  

Additional details of the full inclusion and exclusion criteria, are available upon request or by contacting a study site near you. 

Patients who may be suitable candidates and are interested in learning about participating, can be referred by contacting a participating clinical trial site. 

Disclaimer
2026 Dompé farmaceutici S.p.A. All rights reserved. Cenegermin has not been approved by any regulatory body for use in non-arteritic anterior ischemic optic neuropathy (NAION), and the safety and effectiveness of cenegermin for NAION have not been established. EU CT: 2025-524748-37-00 

Footnotes 

*One-year population-based study in Missouri and Los Angeles County, California.1 

†10-year retrospective study in Olmsted County, Minnesota.2  

‡Retrospective, matched cohort study of neuro-ophthalmic patients at Massachusetts Eye and Ear, Boston from 1 December 2017, through 30 November 2023.10 

References  

1. Hattenhauer MG, Leavitt JA, Gray DT, et al. Incidence of nonarteritic anterior ischemic optic neuropathy. Am J Ophthalmol. 1997 Jan;123(1):103-7. doi: 10.1016/s0002-9394(14)70999-7. 
2. Johnson LN, Arnold AC. Incidence of nonarteritic and arteritic anterior ischemic optic neuropathy. Population-based study in the state of Missouri and Los Angeles County, California. J Neuroophthalmol. 1994 Mar;14(1):38-44. PMID: 8032479.
3. Bouthour W, Biousse V, Newman NJ. Diagnosis of optic disc oedema: fundus features, ocular imaging findings, and artificial intelligence. Neuroophthalmology. 2023 Feb 16;47(4):177-192. doi: 10.1080/01658107.2023.2176522.
4. Miller NR, Arnold AC. Current concepts in the diagnosis, pathogenesis and management of nonarteritic anterior ischaemic optic neuropathy. Eye (Lond). 2015 Jan;29(1):65-79. doi: 10.1038/eye.2014.144. 
5. Repka MX, et al. Am J Ophthalmol.1983 Oct;96(4):478-83. doi: 10.4103/0301-4738.178143
6. Hayreh SS, Zimmerman MB. Nonarteritic anterior ischemic optic neuropathy: natural history of visual outcome. Ophthalmology. 2008 Feb;115(2):298-305.e2. doi: 10.1016/j.ophtha.2007.05.027. 
7. Cestari DM, Gaier ED, Stein JD, et al. Demographic, systemic, and ocular factors associated with nonarteritic anterior ischemic optic neuropathy. Ophthalmology. 2016 Dec;123(12):2446-2455. doi: 10.1016/j.ophtha.2016.08.017. 
8. No authors listed. Arch Ophthalmol. 1996;114(11):1366-74. doi: 10.1001/archopht.1996.01100140566007.
9. Salvetat ML, Pellegrini F, Zeppieri M, et al. Non-arteritic anterior ischemic optic neuropathy (NA-AION): A comprehensive overview. Vision (Basel). 2023 Nov 9;7(4):72. doi: 10.3390/vision7040072.
10. Berry S, Lin WV, Lee AG, et al. Nonarteritic anterior ischemic optic neuropathy: cause, effect, and management. Eye Brain. 2017 Sep 27;9:23-28. doi: 10.2147/EB.S125311.
11. Hathaway JT, Shah MP, Rizzo JF 3rd, et al. Risk of nonarteritic anterior ischemic optic neuropathy in patients prescribed semaglutide. JAMA Ophthalmol. 2024 Aug 1;142(8):732-739. doi: 10.1001/jamaophthalmol.2024.2296. 
12. Grauslund J, Taha AA, Stokholm L, et al. Once-weekly semaglutide doubles the five-year risk of nonarteritic anterior ischemic optic neuropathy in a Danish cohort of 424,152 persons with type 2 diabetes. Int J Retina Vitreous. 2024 Dec 18;10(1):97. doi: 10.1186/s40942-024-00620-x. 
13. Simonsen E, Lund LC, Pottegård A. Use of semaglutide and risk of non-arteritic anterior ischemic optic neuropathy: A Danish-Norwegian cohort study. Diabetes Obes Metab. 2025 Jun;27(6):3094-3103. doi: 10.1111/dom.16316.
14. Cai CX, Hribar M, Ryan PB, et al. Semaglutide and nonarteritic anterior ischemic optic neuropathy. JAMA Ophthalmol. 2025 Apr 1;143(4):304-314. doi: 10.1001/jamaophthalmol.2024.6555.
15. Abbass NJ, Nahlawi R, Singh RP, et al. The effect of semaglutide and GLP-1 RAs on risk of nonarteritic anterior ischemic optic neuropathy. Am J Ophthalmol. 2025 Jun;274:24-31. doi: 10.1016/j.ajo.2025.02.025. 
16. Chou CC, Pan SY, Weng CH, et al. Association between semaglutide and nonarteritic anterior ischemic optic neuropathy: A multinational population-based study. Ophthalmology. 2025 Apr;132(4):381-388. doi: 10.1016/j.ophtha.2024.10.030.
17. Biousse V, Newman NJ. Neuro-Ophthalmology Illustrated. 3rd ed. Thieme Medical Publishers; 2020. doi: 10.1080/01658107.2020.1714667.
18. Scherer RW, Feldon SE, Dickersin K, et al. Ischemic Optic Neuropathy Decompression Trial Research Group. Visual fields at follow-up in the Ischemic Optic Neuropathy Decompression Trial: evaluation of change in pattern defect and severity over time. Ophthalmology. 2008 Oct;115(10):1809-17. doi: 10.1016/j.ophtha.2008.03.020.
19. Kaur K, Margolin E. Treasure Island (FL): StatPearls Publishing; Updated 2025 Sep 14. 
20. Tian R, Zhou Y, Tang W, et al. Wallerian degeneration: From mechanism to disease to imaging. Heliyon. 2024 Dec 5;11(1):e40729. doi: 10.1016/j.heliyon.2024.e40729. 
21. Zhang C et al. Exp Eye Res. 2010 August ; 91(2): 286–292. doi: 10.1016/j.exer.2010.05.021