Myopia

2024 Outcomes Report demonstrates treatment helps clients get well and stay well, regardless of diagnosis or demographics MIAMI, Oct. 30, 2024 /PRNewswire/ -- A new study reveals that over 52% of individuals entering eating disorder treatment began at or above a normal weight, challenging common misconceptions that people must look underweight to require intervention. Although eating disorders are common, many individuals do not receive the help they need. However, data shows that treatment significantly improves recovery outcomes, helping clients stay well for longer. These important insights are part of the largest longitudinal study on eating disorder treatment outcomes, conducted by Monte Nido, one of the nation's leading eating disorder treatment providers. The study reviewed data from 12,000 participants, and results underscore that eating disorders affect people of all shapes and sizes, and that specialized, client-first programs can have lifesaving, long-lasting benefits. Clients Get Well, Stay Well The long-term impact of eating disorder treatment has proven to be an essential component of the healing process. According to the study: 91% of adults and 94% of adolescents restored weight when needed Clients treated by Monte Nido maintained treatment gains 6-months post-discharge: 81% remained significantly improved in ED symptoms 73% remained significantly improved in depression symptoms 71% remained significantly improved in symptoms of anxiety "We believe that recovery is possible for everyone, and our outcomes study demonstrates that treatment can be effective in helping those with eating disorders live the full life they so deserve," Cassie McLean, Chief Executive Officer of Monte Nido. Co-Occurring Diagnoses Are Common The study shows that 85% of all clients had a co-occurring diagnosis of a mood, anxiety or substance use disorder, obsessive compulsive disorder, and/or posttraumatic stress disorder. A co-occurring diagnosis is a significant marker of the complexity of life with an eating disorder. "By addressing both the eating disorder and co-occurring mental health conditions, providers open sustainable pathways for client's healing," McLean emphasized. 45% of adults and 35.4% of adolescents in residential treatment had PTSD These clients demonstrated significantly higher scores on all measures including measures of eating disorder psychopathology, major depression, anxiety disorders and quality of life These clients experience both clinically and statistically significant decreases in their symptoms from admission to discharge Clients who completed cognitive processing therapy (CPT) sessions showed a significant reduction in PCL-5 scores, dropping from an average of 52.6 to 29, which is below the threshold score of 33, meaning clients no longer met criteria for PTSD at the end of treatment. Eating Disorders Don't Discriminate Despite social and cultural expectations about how those with eating disorders appear, they can and do impact anyone, regardless of gender, sexuality, race, ethnicity, age, socio-economic background and size. Nearly 29 million Americans will experience an eating disorder in their lifetime, and very few will get the care they need, largely due to barriers created by discrimination and weight stigma. "This study has shed light on who is living with eating disorders, and that they are far more complex and diverse than our socially conditioned image of those living with an eating disorder," said McLean. "This data will help expand our cultural understanding of individuals that are struggling with a range of eating disorders, and hopefully help remove some of the stigma that so often goes hand-in-hand with a diagnosis." Size & Weight 52% of people entering treatment were at or above "normal" weight at admission according to the NIH body mass index (BMI) calculator Most clients who were diagnosed with other specified feeding or eating disorder (OSFED) have atypical anorexia nervosa Gender & Sexuality 36% of all clients identified as LGBTQIA+ 63% of LGBTQIA+ adults in residential treatment met criteria for PTSD, compared to 45% cisgender heterosexual adults Age 77.6% of adolescents in residential treatment (average age of 15) had a co-occurring diagnosis, such as a mood disorder, anxiety disorder, or PTSD. 38% reported that someone else in their family has struggled with an eating disorder or disordered eating 75% of these adolescents had their families that were either very or extremely involved in treatment as indicated by regular family therapy and consistent communication with the clinical team Data Shines a Light on ARFID and BED Findings also emphasize the commonality of two lesser-known eating disorders, avoidant/restrictive food intake disorder (ARFID) and binge eating disorder (BED) within the client population. This data is important as certain disorders, like BED, are often misunderstood and misdiagnosed due to an overreliance on BMI as a measure of health. This misconception can lead to inadequate treatment, and even unhelpful guidance from providers. Adults, with an average admission age of 32, had binge eating disorder for 20 years before receiving treatment at Monte Nido, and 14 years before seeking any form of treatment. Clients with BED got better on all measures in all levels of care ARFID, which is characterized by "selective behaviors" or disinterest in food, has historically been difficult to diagnose, explaining why it's sometimes considered a "new" eating disorder. This year, Monte Nido developed the first measuring tool of its kind to help inform ARFID treatment, the Food Flexibility Scale™, which illustrates the levels of food flexibility that clients achieve through treatment. By using the novel food flexibility scale that measures progress across various degrees of variety, volume, and exposure to different food settings, the study indicates significant growth over the course of treatment. Of clients treated for ARFID, 92% of clients reached adequate nutritional intake levels by the end of treatment. Flexible Treatment Modalities Increase Accessibility The study also highlights the importance of flexible treatment options in improving accessibility, particularly through expanded virtual programs. These options allow clients to receive care despite geographic, scheduling, or familial barriers. "Access to flexible, innovative treatment options, especially virtual programs, is a game-changer for clients who might otherwise forgo the care they need," said Molly Perlman, MD, MPH, CEDS-C, Chief Medical Officer of Monte Nido. "By removing obstacles, virtual treatment is transforming how and when individuals seek help, making care more adaptable to real-life demands." Regardless of being in-person or online, data shows that less-intensive but highly structured remote treatment facilitates meaningful recovery among clients. 88% of clients discharged from virtual treatment described their experience as good to excellent Clients discharging from virtual programs with Monte Nido rated their experience with program staff- including clinical directors, primary therapists, dieticians, recovery coaches, their psychiatric and medical providers as excellent on average For more information about Monte Nido or to read the complete study, click here. To inquire about treatment at one of the Monte Nido programs, please visit . About the Monte Nido 2024 Outcomes Report The 2024 Outcomes Report is based on analysis of outcomes from Monte Nido programs nationwide, spanning all levels of care and more than 12,000 clients. Clients who consented to participate in the research study completed a series of clinical questionnaires at select intervals: at admission, upon transfer to a new level of care, and upon discharge from a program. In addition, follow-up data was obtained from consenting clients at specified time points after discharge. About Monte Nido Monte Nido is a national mental health provider committed to eradicating eating disorders by offering industry-leading care to adults and adolescents of all genders in a healing environment. Our clinically comprehensive, research-backed treatment in inpatient, residential, and day and virtual treatment programs show exceptional outcomes. Our clients get well and stay well six months after treatment. Founded in 1996, our expert staff of eating disorder professionals deliver compassionate care, breakthrough outcomes, and long-term recovery for our clients. Monte Nido operates 50 programs and in 28 states virtually across our family of programs: Monte Nido, Monte Nido Walden, Monte Nido Rosewood, and Monte Nido Clementine. Contact: Hannah Miller L.C. Williams & Associates 312-565-3900 [email protected] SOURCE Monte Nido WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Publication in the Journal of Ocular Pharmacology and Therapeutics highlights the ability of the Optejet to achieve a therapeutic dose of medication with far less exposure to harmful preservatives Additional presentation at the American Academy of Optometry summarizes a Phase 4 study of Mydcombi demonstrating that clinically relevant mydriasis can be achieved with a half-dose per eye NEW YORK, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, today announced a publication in the Journal of Ocular Pharmacology and Therapeutics as well as an upcoming presentation at the American Academy of Optometry’s “Academy 2024 Indianapolis” Annual Meeting. Publication in the Journal of Ocular Pharmacology and Therapeutics The peer-reviewed paper highlights the ability of Eyenovia’s proprietary Optejet dispenser to deliver a therapeutic dose of latanoprost with far less exposure to the preservative benzalkonium chloride (BAK) than traditional eye drops. BAK, in larger volumes, can cause unwanted side effects, including cytotoxicity, cytoplasmic shrinkage, and loss of cell-cell contact, and expression of chemokine (C-C motif) ligand 2 and interleukin-6 (markers of inflammation). In contrast, this in-vitro study of latanoprost plus BAK delivered in the same amount by the Optejet dispenser (8 microliters) avoided the cytotoxicity associated with larger volumes found in eye drops and was similar to no treatment controls and BAK-free latanoprost drops. “We have shown in prior studies the ability of the Optejet dispenser to achieve a therapeutic dose of medication with approximately 80% less volume and exposure to harmful preservatives than traditional eye drops,” stated Michael Rowe, Chief Executive Officer of Eyenovia. “The implication here is that preserved medications may not need to be reformulated to get many of the benefits of non-preserved products if delivered with the Optejet. We believe this creates potential opportunities for the Optejet to improve the administration of topical ocular therapeutics well beyond our own development pipeline.” Presentation at the American Academy of Optometry’s “Academy 2024” Eyenovia also announced today an upcoming presentation at the American Academy of Optometry’s “Academy 2024 Indianapolis,” which is being held November 6-9, in Indianapolis, IN. The presentation details the results of an open-label Phase 4 study of 1% tropicamide and 2.5% phenylephrine ophthalmic metered spray, similar to Mydcombi, Eyenovia’s commercially available product for inducing mydriasis. Twenty-nine subjects completed the study and administered one spray. Baseline pupil diameter (PD) for all eyes was 2.74±0.48 mm. Mean change in PD from baseline to 30 minutes was 3.69±1.25 mm. At 30 minutes post-dosing, mean PD was 6.42±1.25 mm, with 67% and 43% of eyes dilated to ≥ 6mm and 7mm, respectively. The majority of patients returned to functional vision (PD ≤ 5 mm) as early as 3.5 hours post-instillation, with 93% reaching that point by six hours. Safety outcomes were favorable, as only mild adverse events were reported (dry eye and mild instillation site pain) all of which resolved without intervention. “We conducted this study to address questions from doctors about modulating dosing for patients who may benefit from a lower dose of tropicamide or phenylephrine,” stated Dr. Julie Whitcomb, Senior Director of Medical Affairs at Eyenovia. “What we found in this study was that a half dose may also provide clinically relevant pupil dilation, was well-tolerated, and had a desirable shorter duration of effect.” Presentation details: Title:An Open Label, Phase 4 Study of the Safety and Efficacy of Fixed Combination Tropicamide 1% and Phenylephrine 2.5% Ophthalmic Spray (MydCombi®)Poster:#109, Exhibit Hall HPresenter:Dr. Josianne Manasse, OD, SUNY College of OptometryDate/time:Friday, November 8th, 1:00-3:00pm For additional information on the Expo: https://aaopt.org/meetings/academy-2024-indianapolis/ About Eyenovia, Inc. Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic technology company developing a pipeline of advanced products based on its Optejet platform. Eyenovia is currently focused on the commercialization of Mydcombi® for mydriasis, clobetasol propionate ophthalmic suspension, 0.05% for post-surgical pain and inflammation, as well as the ongoing late-stage development of medications in the Optejet device for pediatric progressive myopia as well as out-licensing for additional indications. For more information, visit Eyenovia.com. The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations. PLEASE GO TO MYDCOMBI.COM FOR IMPORTANT SAFETY INFORMATION for MYDCOMBI™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% PLEASE GO TO CLOBETASOLBID.COM FOR IMPORTANT SAFETY INFORMATION for Clobetasol Propionate Ophthalmic Suspension 0.05% Forward-Looking StatementsExcept for historical information, all the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including the timing and scale of acceptance and use of our approved products. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission. In addition, such statements could be affected by risks and uncertainties related to, among other things: risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment, timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our products and product candidates; the potential advantages of our products, product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our products and product candidates; our estimates regarding the potential market opportunity for our products and product candidates; reliance on third parties to develop and commercialize our products and product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products and product candidates; intellectual property risks; changes in legal, regulatory, legislative and geopolitical environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products and product candidates; and our competitive position. Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake any obligation to update any forward-looking statements. Eyenovia Contact:Eyenovia, Inc.Andy Jones Chief Financial Officerajones@eyenovia.comEyenovia Investor Contact:Eric RibnerLifeSci Advisors, LLCeric@lifesciadvisors.com(646) 751-4363Eyenovia Media Contact:Eyenovia, Inc.Norbert LoweVice President, Commercial Operationsnlowe@eyenovia.com

The ELEVATUM study showed clinically meaningful improvement in vision and reduction in retinal fluid in people with diabetic macular edema (DME) treated with Vabysmo who identify as African American, Black, Hispanic and Latino1 Efficacy and safety from this phase IV study were consistent with data from the Vabysmo phase III DME studies1These racial and ethnic groups are disproportionately affected by diabetes and at higher risk of developing DME, a leading cause of vision loss2-3 Basel, 18 October 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive topline one-year results from the open-label, single-arm phase IV ELEVATUM study evaluating Vabysmo® (faricimab) for the treatment of diabetic macular edema (DME) in people from racial and ethnic groups that are often underrepresented in clinical trials.4 Initial data from 124 participants in the United States (US) showed that after one year of treatment with Vabysmo, administered every eight weeks, participants could read an additional 12.3 letters on average – equivalent to about two and a half lines on an eye chart. Results among major racial and ethnic groups represented in this study were similar. Hispanic and Latino participants started the study with the most severe disease and had an average vision gain of 14.1 letters from baseline at one year, equivalent to nearly three lines on an eye chart. African American and Black participants gained an average of 11.3 letters from baseline at one year. Vabysmo was well tolerated, with no new safety events identified.1 These data were presented in a late-breaking oral presentation at the American Academy of Ophthalmology (AAO) 2024 Annual Meeting in Chicago, Illinois, on 18 October.1 The study is the first retina trial for historically underrepresented populations. “Vabysmo has been shown to be an effective first-line treatment for diabetic macular edema, and for the first time, we have data specifically demonstrating its ability to improve vision in Black, African American, Hispanic and Latino patients who are disproportionately impacted by this condition,” said investigator Jeremiah Brown, M.D., of Retina Consultants of Texas, who presented the data at AAO. “As a clinician who serves patients from these communities that are so often underrepresented in clinical trials, I believed it was important to take part in this groundbreaking study, and hope the findings will inform and improve the care we provide to our patients in the clinic daily.” Results were consistent with the phase III YOSEMITE and RHINE DME studies.5 A secondary endpoint showed robust retinal drying with Vabysmo across these racial and ethnic groups, who, on average, achieved a decrease of 206.3 microns in central subfield thickness (CST) from baseline.1 Reducing CST indicates retinal drying, which is an important clinical measure, as swelling from excess fluid in the back of the eye is associated with distorted and blurred vision.6 “We established ELEVATUM to specifically evaluate Vabysmo in underrepresented populations,” said Nilesh Mehta, Roche’s Global Therapeutic Area Head for Ophthalmology. “Including diverse populations and perspectives is part of our broader Roche Diversity, Equity & Inclusion (DE&I) strategy and is essential if we want to improve scientific understanding of diabetic macular edema and ultimately improve standard of care for all people living with this condition.” Among the 124 patients, 45% self-identified as Hispanic or Latino, and 48% as Black or African American.1 The study was designed to facilitate enrolment and promote retention of underrepresented patients. For example, ELEVATUM was conducted at sites that treat a high proportion of these populations in urban, rural and community-based locations. In addition, eligibility criteria allowed participants with a haemoglobin A1c (HbA1c) level up to 12%.4 An HbA1c test measures a person’s average blood sugar levels over the past three months and is used to diagnose diabetes.7 Typically, the threshold for DME trials is an HbA1c level of 10%. However, HbA1c levels can be higher in Black, African American, Hispanic and Latino populations compared with Caucasians, meaning a lower HbA1c threshold can inadvertently lead to the exclusion of patients from various ethnic and racial groups.8-9 To date, Vabysmo is approved in more than 100 countries for DME and neovascular or ‘wet’ age-related macular degeneration, and in over 30 countries for macular edema following retinal vein occlusion (RVO). More than five million doses of Vabysmo have been distributed globally since its initial US approval in 2022.10-15 About ELEVATUM4 ELEVATUM (NCT05224102) is a phase IV, multicentre, open-label, single-arm study designed to evaluate Vabysmo® (faricimab) as a treatment for diabetic macular edema (DME) in patients that have been historically underrepresented in clinical trials, including people who self-identify as Black, African American, Hispanic or Latino. Trial participants have not been treated with an anti‑vascular endothelial growth factor before the study. They receive treatment every four weeks with Vabysmo up to week 20, followed by treatment every eight weeks up to week 52. The primary endpoint is change from baseline in best corrected visual acuity at week 56. Secondary endpoints include safety and change in central subfield thickness from baseline over time. About Diabetic Macular Edema Affecting around 29 million people globally, diabetic macular edema (DME) is a vision-threatening retinal condition associated with blindness and decreased quality of life when left untreated.16-17 DME occurs when damaged blood vessels leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for reading and driving.18-19 The number of people with DME is expected to grow as the prevalence of diabetes increases.20 About the Vabysmo® (faricimab) clinical development programmeRoche has a robust phase III clinical development programme for Vabysmo. The programme includes AVONELLE-X, an extension study of TENAYA and LUCERNE, evaluating the long-term safety and tolerability of Vabysmo in neovascular or ‘wet’ age-related macular degeneration (nAMD), and RHONE-X, an extension study of YOSEMITE and RHINE, evaluating the long-term safety and tolerability of Vabysmo in diabetic macular edema (DME).21-22 The POYANG study is evaluating Vabysmo in adult treatment-naive patients with choroidal neovascularisation secondary to pathologic myopia.23 Roche has initiated several phase IV studies, including the ELEVATUM study of Vabysmo in underrepresented patient populations with DME and the SALWEEN study of Vabysmo in a subpopulation of nAMD highly prevalent in Asia.4, 24 Roche has also initiated the VOYAGER study, a global real-world data collection platform, and supports several other independent studies to further understand retinal conditions with a high unmet need.25 About Vabysmo® (faricimab)Vabysmo is the first bispecific antibody approved for the eye.11, 26 It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.5, 26 Vabysmo is approved in more than 100 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union (EU) for people living with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in more than 30 countries, including the US, EU and Japan, for people living with macular edema following retinal vein occlusion. Review by other health authorities is ongoing.10-15 About Roche in OphthalmologyRoche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients. We have the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye diseases. Our pipeline includes innovative treatments across different modalities, such as antibodies, and gene and cell therapies targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema. Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo® (previously called Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant is the first United States (US) Food and Drug Administration-approved refillable eye implant for neovascular or ‘wet’ age-related macular degeneration (nAMD) that continuously delivers a customised formulation of ranibizumab over a period of months.27, 28 Vabysmo® (faricimab) is the first bispecific antibody approved for the eye, which targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 and vascular endothelial growth factor-A.5, 11, 12, 26 Vabysmo is approved around the world for people living with nAMD, diabetic macular edema and macular edema following retinal vein occlusion.10-15 Lucentis® (ranibizumab injection)* was the first treatment approved to improve vision in people with certain retinal conditions.29 About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. *Lucentis® (ranibizumab injection) was developed by Genentech, a member of the Roche Group. Genentech retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world. All trademarks used or mentioned in this release are protected by law.References[1] Emanuelli A. ELEVATUM, the First Industry Sponsored Trial Focused on Underrepresented Patients in Retina in the US. Presented at: American Academy of Ophthalmology (AAO) Annual Meeting; 2024, October 18; Chicago, IL, USA.[2] Coney J, Scott A. Racial disparities in the screening and treatment of diabetic retinopathy. Journal of the National Medical Association. 2022;114 (2):171-181.[3] Lee R, et al. Epidemiology of diabetic retinopathy, DME and related vision loss. Eye and Vision. 2015; 2, 17.[4] Clinical Trials.gov. A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema (ELEVATUM) [Internet; cited October 2024]. Available from: https://www.clinicaltrials.gov/study/NCT05224102.[5] Wykoff C, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with DME (YOSEMITE and RHINE): Two randomised, double-masked, phase III trials. The Lancet. 2022; 399:741-755.[6] US National Institutes of Health - National Eye Institute. Macular edema. 2023. [Internet; cited October 2024]. Available from: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/macular-edema.[7] Eyth E, Naik R. Hemoglobin A1C. 2023. [Internet; cited October 2024]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK549816/.[8] Cavagnolli G, et al. Effect of ethnicity on HbA1c levels in individuals without diabetes: Systematic review and meta-analysis. PloS one. 2017;12 (2).[9] Borkar DS, et al. Understanding the impact of HbA1c thresholds on DME clinical trial eligibility by race. Presented at: AAO 2023; November 3-6, 2023; San Francisco, CA, USA. Poster PO492.[10] European Medicines Agency. Summary of product characteristics, Vabysmo. 2022. [Internet; cited October 2024]. Available from: https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf.[11] US FDA. Highlights of prescribing information, Vabysmo. 2023 [Internet; cited October 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761235s003lbl.pdf.[12] Medicines and Healthcare products Regulatory Agency approves faricimab through international work-sharing initiative. [Internet; cited October 2024]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.[13] Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. [Internet; cited October 2024]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html.[14] Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for nAMD and DME. [Internet; cited October 2024]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.[15] Roche data on file.[16] Im JHB, et al. Prevalence of DME based on optical coherence tomography in people with diabetes: a systematic review and meta-analysis. Survey of Ophthalmology. 2022 Jul-Aug;67(4):1244-1251.[17] The Lancet. Diabetes: A defining disease of the 21st century. Lancet. 2023 24;401 (10394):2087.[18] All About Vision. Macula lutea. [Internet; cited October 2024]. Available from: https://www.allaboutvision.com/resources/macula.[19] National Eye Institute. Diabetic Retinopathy. [Internet; cited October 2024]. Available from: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/diabetic-retinopathy.[20] Liu E, et al. DME: Clinical risk factors and emerging genetic influences. Clinical and Experimental Optometry. 2017;100:569–76.[21] Clinical Trials.gov. A study to evaluate the long-term safety and tolerability of Vabysmo in participants with nAMD (AVONELLE-X). [Internet; cited October 2024]. Available from: https://clinicaltrials.gov/ct2/show/NCT04777201. [22] Clinical Trials.gov. Clinical Trials.gov. A study to evaluate the long-term safety and tolerability of Vabysmo in participants with diabetic macular edema (DME) (RHONE-X). [Internet; cited October 2024]. Available from: https://clinicaltrials.gov/ct2/show/NCT04432831.[23] Clinical Trials.gov. A study to evaluate the efficacy and safety of faricimab in patients with choroidal neovascularization secondary to pathologic myopia (POYANG). [Internet; cited October 2024]. Available from: https://www.clinicaltrials.gov/study/NCT06176352.[24] APVRS. Design and rationale of the SALWEEN trial: A phase IIIb/IV study of faricimab, a dual angiopoietin-2 and vascular endothelial growth factor-a inhibitor, in patients with polypoidal choroidal vasculopathy. [Internet; cited October 2024]. Available from: https://2022.apvrs.org/abstract/?code=200351.[25] Clinical Trials.gov. A real-world study to gain clinical insights into Roche ophthalmology products (VOYAGER). [Internet; cited October 2024]. Available from: https://clinicaltrials.gov/ct2/show/NCT05476926.[26] Heier JS, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for nAMD (TENAYA and LUCERNE): two randomised, double-masked, phase III, non-inferiority trials. The Lancet. 2022; 399:729-40.[27] US FDA. Highlights of prescribing information, Susvimo. 2021. [Internet; cited October 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf.[28] Holekamp N, et al. Archway randomised phase III trial of the Port Delivery System with ranibizumab for neovascular age-related macular degeneration (nAMD). Ophthalmology. 2021.[29] US FDA. Highlights of prescribing information, Lucentis. 2014. [Internet; cited October 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262 Yvette PetillonPhone: +41 79 961 92 50 Dr. Rebekka SchnellPhone: +41 79 205 27 03 Attachment 18102024_MR_Vabysmo ELEVATUM study _en