Allegro Ophthalmics LLC

- Intermediate Dry AMD Treatment Is a Significant Unmet Need - Mitochondrial Stabilizing Candidate Risuteganib Has Shown Best Corrected Visual Acuity Gains in Dry AMD Patient Population Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel mitochondrial stabilizers for the treatment of ocular diseases, today announced that the Company has received agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design of its Phase 2b/3 clinical trial of risuteganib (Luminate®) for the treatment of intermediate, non-exudative age-related macular degeneration (dry AMD). Finalization of this assessment indicates that the FDA agrees that critical elements of the overall protocol design (e.g., entry criteria, dose selection, endpoints, and planned analyses) are adequate and acceptable for a study intended to support a future marketing application. "We are excited that the overall protocol design of our Phase 2b/3 dry AMD clinical trial was finalized by the FDA," said Vicken Karageozian, M.D., President and CEO of Allegro Ophthalmics, LLC. "The agreement by the FDA of the SPA provides a clear regulatory path for our first-in-class drug, risuteganib, for the treatment of intermediate dry AMD for an unmet medical need. This is important because dry AMD leads to irreversible, and in many cases catastrophic, vision loss. A therapy to treat this disease is greatly needed." The agreement by the FDA of the SPA provides a clear regulatory path for risuteganib for intermediate dry AMD. The Phase 2b/3 study design is based on Allegro's successfully completed U.S. Phase 2a study, in which the primary endpoint was the proportion of subjects with a gain of ≥ 8 letters of vision with two risuteganib injections versus one sham treatment. The Phase 2a trial was a prospective, randomized, double masked, placebo-controlled, multi-center U.S. study that evaluated the safety and efficacy of risuteganib in patients with intermediate dry AMD. The primary endpoint was met, with 48 percent of patients in the risuteganib arm at week 28 and 7 percent of patients in the sham group at week 12 gaining ≥ 8 letters from baseline (p=0.013). Risuteganib was found to be safe, with no reported drug related serious adverse events (SAEs). Additional findings that support the visual acuity improvement included improvements in retinal sensitivity (microperimetry) and color vision (Lanthony color test). The Phase 2b/3a study will evaluate efficacy at 52 weeks and safety through 96 weeks. Patients will receive 5 intravitreal injections (IVTs) 12 weeks apart with continued IVT treatment during the follow-up safety portion of the study. The primary endpoint of the study is the improvement in best corrected visual acuity (BCVA) at 52 weeks in the active risuteganib group vs the sham control group. This study design also includes threshold OCT screening, such as minimum ellipsoid zone and photoreceptor layer thickness, that strongly predicts BCVA response to treatment, thus helping clinicians predict outcomes and select the patients most likely to benefit from treatment. About Allegro Ophthalmics, LLC Allegro Ophthalmics, LLC is a privately held biopharmaceutical company focused on the development of novel oxidative stress stabilizers for the treatment of ocular diseases. Pre-clinical data suggest that risuteganib (Luminate®), Allegro's lead investigational compound in retina, may simultaneously act on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases, such as dry AMD. A U.S. Phase 2a study with risuteganib in less advanced dry AMD met its primary endpoint of vision recovery. Expanding its oxidative stress-stabilizing portfolio, Allegro developed ALG-1007 for topical use in dry eye disease. ALG-1007 demonstrated promising results in two ex-U.S. studies in humans. For more information, visit www.allegroeye.com. SOURCE Allegro Ophthalmics

- Intermediate Dry AMD Treatment Highlighted as Significant Unmet Need - Only Mitochondrial Stabilizing Candidates, Including Allegro's Risuteganib, Have Shown Best Corrected Visual Acuity (BCVA) Gains in this Patient Population SAN JUAN CAPISTRANO, Calif., Feb. 10, 2023 /PRNewswire/ -- Allegro Ophthalmics, LLC, a privately held biopharmaceutical company focused on the development of novel oxidative stress stabilizers for the treatment of ocular diseases, today announced the presentation of key data supporting dry AMD pipeline candidates, including the company's risuteganib (Luminate®), this morning at Bascom Palmer Eye Institute's 20th annual Angiogenesis, Exudation and Degeneration meeting, being held virtually February 10-11, 2023.1 Esteemed ophthalmologist and researcher Dr. Baruch Kuppermann*, Roger F. Steinert professor, chair of the Department of Ophthalmology, and director of the Gavin Herbert Eye Institute at the University of California, Irvine, shared clinical evidence as well as considerations for matching mechanism of action (MOA) with the right patient population and stage of disease to reverse vision loss in dry AMD, which affects more than 15 million patients in the United States alone. During his presentation to an audience of retina specialists, general ophthalmologists and researchers, Dr. Kuppermann highlighted that most Dry AMD pipeline candidates currently focus on treating geographic atrophy (GA), an advanced stage of the disease, which accounts for only 10% of Dry AMD patients, as opposed to those with early and intermediate disease, who make up 40% of the total Dry AMD patient population. The only two pipeline candidates that have shown best corrected visual acuity (BCVA) gains in intermediate dry AMD are mitochondrial stabilizing drugs, including risuteganib. Importantly, Dr. Kuppermann also illustrated how these candidates have shown threshold OCT characteristics, such as minimum ellipsoid zone and photoreceptor layer thickness, that strongly predicts BCVA response to treatment, thus helping clinicians predict outcomes and select the patients most likely to benefit from treatment. "Existing data suggest that restoration of functional vision is achievable in Dry AMD patients with more anatomical integrity, or less disease progression, using these mitochondrial stabilizing drug candidates," explained Dr. Kuppermann. "This underscores the potential for early treatment of Dry AMD, with the right therapeutic agent, to reverse vision loss." "The Angiogenesis, Exudation and Degeneration meeting is an important forum for the retinal professional community, and we are grateful to Dr. Kuppermann for presenting this compelling information together in a context in which it has not been shared before," said Vicken Karageozian, M.D., President and CEO of Allegro Ophthalmics, LLC. "Treatments for Dry AMD remain a significant unmet need, and we believe that, given the evidence and considerations put forth by Dr. Kuppermann, risuteganib has tremendous potential to help address that need." About Allegro Ophthalmics, LLC Allegro Ophthalmics, LLC is a privately held biopharmaceutical company focused on the development of novel oxidative stress stabilizers for the treatment of ocular diseases. Pre-clinical data suggest that risuteganib (Luminate®), Allegro's lead investigational compound in retina, may simultaneously act on the angiogenic, inflammatory and mitochondrial metabolic pathways implicated in diseases, such as dry AMD. A U.S. Phase 2a study with risuteganib in less advanced dry AMD met its primary endpoint of vision recovery. Expanding its oxidative stress-stabilizing portfolio, Allegro developed ALG-1007 for topical use in dry eye disease. ALG-1007 demonstrated promising results in two ex-U.S. studies in humans. For more information, visit . Risuteganib (Luminate®) and ALG-1007 are investigational drugs and are not approved for commercial sale. Luminate® is a registered trademark of Allegro Ophthalmics, LLC. *Dr. Kuppermann is a member of Allegro's Medical Advisory Board. References 1. Kuppermann B. "Reversing Vision Loss in dry AMD: Matching Mechanism with the Right Patient and Stage of Disease." Angiogenesis, Exudation and Degeneration Meeting, February 10-11, 2023, online. MEDIA CONTACT: Michele Gray Gray Communications, LLC. (917) 449-9250 [email protected] SOURCE Allegro Ophthalmics

NEW YORK, Oct. 14, 2022 /PRNewswire/ -- The age-related macular degeneration (AMD) therapeutics market size is expected to grow by USD 9.37 billion from 2021 to 2026. In addition, the growth momentum of the market will accelerate at a CAGR of 12.6% during the forecast period, according to Technavio. The high prevalence of AMD is driving the age-related macular degeneration (AMD) therapeutics market growth. However, factors such as the lack of approved therapies for dry AMD may challenge the market growth. Continue Reading Technavio has announced its latest market research report titled Global Age-Related Macular Degeneration (AMD) Therapeutics Market 2022-2026 This report offers an up-to-date analysis regarding the latest trends and drivers, the current market scenario, and the overall market environment. Read FREE PDF Sample Report Age-related Macular Degeneration Therapeutics Market 2022-2026: Segmentation Type Wet AMD: The wet AMD segment will be the largest contributor to market growth during the forecast period. Factors such as the rising use of vascular endothelial growth factor (VEGF) inhibitors, which are largely used for the treatment of wet AMD, are driving the growth of the segment. Dry AMD Geography North America: North America will account for 42% of the market's growth during the forecast period. The growth of the market is attributed to factors such as the high prevalence of AMD. Moreover, the growth of the market in this region is expected to be faster than the growth of the market in Europe. The US and Canada are the key countries for the age-related macular degeneration (AMD) therapeutics market in North America. Europe Asia Rest Of World (ROW) Learn about the contribution of each segment summarized in concise infographics and thorough descriptions. View a FREE PDF Sample Report Age-related Macular Degeneration Market 2022-2026: Vendor Analysis and Scope To help businesses improve their market position, Technavio's report provides a detailed analysis of around 25 vendors operating in the market. Market vendors must strengthen their foothold in the fast-growing segments to leverage the current opportunities while maintaining their positions in the slow-growing segments. Some of the major vendors of the age-related macular degeneration market include Alimera Sciences Inc., Alkeus Pharmaceuticals Inc., Allegro Ophthalmics LLC, Amgen Inc., Apellis Pharmaceuticals Inc., Bausch Health Co Inc, Bayer AG, F. Hoffmann La Roche Ltd., Formycon AG, Intas Pharmaceuticals Ltd., Novartis AG, Outlook Therapeutics Inc., Regeneron Pharmaceuticals Inc., Reliance Industries Ltd., Santen Pharmaceutical Co. Ltd., and Xbrane Biopharma AB. The report also covers the following areas : Age-related Macular Degeneration Market size Age-related Macular Degeneration Market trends Age-related Macular Degeneration Market industry analysis Get lifetime access to our Technavio Insights. Subscribe now to our most popular "Basic Plan" billed annually at USD 5000 . View 100 reports and download 5 reports monthly! Age-related Macular Degeneration Market 2022-2026: Key Highlights CAGR of the market during the forecast period Detailed information on factors that will assist age-related macular degeneration market growth during the next five years Estimation of the size of the age-related macular degeneration market and its contribution to the parent market Forecasts on upcoming trends and changes in consumer behavior The growth of the age-related macular degeneration market Analysis of the competitive landscape of the market and detailed information on vendors Comprehensive details of factors that will impede the growth of age-related macular degeneration market vendors Related Reports Open-Angle Glaucoma Therapeutics Market by Product and Geography - Forecast and Analysis 2022-2026: The open-angle glaucoma therapeutics market share is expected to increase by USD 2.58 billion from 2021 to 2026. Myopia and Presbyopia Treatment Market by Type and Geography - Forecast and Analysis 2022-2026: Myopia and presbyopia treatment market share is expected to increase by USD 7.22 billion from 2021 to 2026. Browse Health Care Market Reports Table of Contents 1 Executive Summary 1.1 Market overview Exhibit 01: Executive Summary – Chart on Market Overview Exhibit 02: Executive Summary – Data Table on Market Overview Exhibit 03: Executive Summary – Chart on Global Market Characteristics Exhibit 04: Executive Summary – Chart on Market by Geography Exhibit 05: Executive Summary – Chart on Market Segmentation by Type Exhibit 06: Executive Summary – Chart on Incremental Growth Exhibit 07: Executive Summary – Data Table on Incremental Growth Exhibit 08: Executive Summary – Chart on Vendor Market Positioning 2 Market Landscape 2.1 Market ecosystem Exhibit 09: Parent market Exhibit 10: Market Characteristics 3 Market Sizing 3.1 Market definition Exhibit 11: Offerings of vendors included in the market definition 3.2 Market segment analysis Exhibit 12: Market segments 3.3 Market size 2021 3.4 Market outlook: Forecast for 2021-2026 Exhibit 13: Chart on Global - Market size and forecast 2021-2026 ($ million) Exhibit 14: Data Table on Global - Market size and forecast 2021-2026 ($ million) Exhibit 15: Chart on Global Market: Year-over-year growth 2021-2026 (%) Exhibit 16: Data Table on Global Market: Year-over-year growth 2021-2026 (%) 4 Five Forces Analysis 4.1 Five forces summary Exhibit 17: Five forces analysis - Comparison between 2021 and 2026 4.2 Bargaining power of buyers Exhibit 18: Chart on Bargaining power of buyers – Impact of key factors 2021 and 2026 4.3 Bargaining power of suppliers Exhibit 19: Bargaining power of suppliers – Impact of key factors in 2021 and 2026 4.4 Threat of new entrants Exhibit 20: Threat of new entrants – Impact of key factors in 2021 and 2026 4.5 Threat of substitutes Exhibit 21: Threat of substitutes – Impact of key factors in 2021 and 2026 4.6 Threat of rivalry Exhibit 22: Threat of rivalry – Impact of key factors in 2021 and 2026 4.7 Market condition Exhibit 23: Chart on Market condition - Five forces 2021 and 2026 5 Market Segmentation by Type 5.1 Market segments Exhibit 24: Chart on Type - Market share 2021-2026 (%) Exhibit 25: Data Table on Type - Market share 2021-2026 (%) 5.2 Comparison by Type Exhibit 26: Chart on Comparison by Type Exhibit 27: Data Table on Comparison by Type 5.3 Wet AMD - Market size and forecast 2021-2026 Exhibit 28: Chart on Wet AMD - Market size and forecast 2021-2026 ($ million) Exhibit 29: Data Table on Wet AMD - Market size and forecast 2021-2026 ($ million) Exhibit 30: Chart on Wet AMD - Year-over-year growth 2021-2026 (%) Exhibit 31: Data Table on Wet AMD - Year-over-year growth 2021-2026 (%) 5.4 Dry AMD - Market size and forecast 2021-2026 Exhibit 32: Chart on Dry AMD - Market size and forecast 2021-2026 ($ million) Exhibit 33: Data Table on Dry AMD - Market size and forecast 2021-2026 ($ million) Exhibit 34: Chart on Dry AMD - Year-over-year growth 2021-2026 (%) Exhibit 35: Data Table on Dry AMD - Year-over-year growth 2021-2026 (%) 5.5 Market opportunity by Type Exhibit 36: Market opportunity by Type ($ million) 6 Customer Landscape 6.1 Customer landscape overview Exhibit 37: Analysis of price sensitivity, lifecycle, customer purchase basket, adoption rates, and purchase criteria 7 Geographic Landscape 7.1 Geographic segmentation Exhibit 38: Chart on Market share by geography 2021-2026 (%) Exhibit 39: Data Table on Market share by geography 2021-2026 (%) 7.2 Geographic comparison Exhibit 40: Chart on Geographic comparison Exhibit 41: Data Table on Geographic comparison 7.3 North America - Market size and forecast 2021-2026 Exhibit 42: Chart on North America - Market size and forecast 2021-2026 ($ million) Exhibit 43: Data Table on North America - Market size and forecast 2021-2026 ($ million) Exhibit 44: Chart on North America - Year-over-year growth 2021-2026 (%) Exhibit 45: Data Table on North America - Year-over-year growth 2021-2026 (%) 7.4 Europe - Market size and forecast 2021-2026 Exhibit 46: Chart on Europe - Market size and forecast 2021-2026 ($ million) Exhibit 47: Data Table on Europe - Market size and forecast 2021-2026 ($ million) Exhibit 48: Chart on Europe - Year-over-year growth 2021-2026 (%) Exhibit 49: Data Table on Europe - Year-over-year growth 2021-2026 (%) 7.5 Asia - Market size and forecast 2021-2026 Exhibit 50: Chart on Asia - Market size and forecast 2021-2026 ($ million) Exhibit 51: Data Table on Asia - Market size and forecast 2021-2026 ($ million) Exhibit 52: Chart on Asia - Year-over-year growth 2021-2026 (%) Exhibit 53: Data Table on Asia - Year-over-year growth 2021-2026 (%) 7.6 Rest of World (ROW) - Market size and forecast 2021-2026 Exhibit 54: Chart on Rest of World (ROW) - Market size and forecast 2021-2026 ($ million) Exhibit 55: Data Table on Rest of World (ROW) - Market size and forecast 2021-2026 ($ million) Exhibit 56: Chart on Rest of World (ROW) - Year-over-year growth 2021-2026 (%) Exhibit 57: Data Table on Rest of World (ROW) - Year-over-year growth 2021-2026 (%) 7.7 US - Market size and forecast 2021-2026 Exhibit 58: Chart on US - Market size and forecast 2021-2026 ($ million) Exhibit 59: Data Table on US - Market size and forecast 2021-2026 ($ million) Exhibit 60: Chart on US - Year-over-year growth 2021-2026 (%) Exhibit 61: Data Table on US - Year-over-year growth 2021-2026 (%) 7.8 Germany - Market size and forecast 2021-2026 Exhibit 62: Chart on Germany - Market size and forecast 2021-2026 ($ million) Exhibit 63: Data Table on Germany - Market size and forecast 2021-2026 ($ million) Exhibit 64: Chart on Germany - Year-over-year growth 2021-2026 (%) Exhibit 65: Data Table on Germany - Year-over-year growth 2021-2026 (%) 7.9 UK - Market size and forecast 2021-2026 Exhibit 66: Chart on UK - Market size and forecast 2021-2026 ($ million) Exhibit 67: Data Table on UK - Market size and forecast 2021-2026 ($ million) Exhibit 68: Chart on UK - Year-over-year growth 2021-2026 (%) Exhibit 69: Data Table on UK - Year-over-year growth 2021-2026 (%) 7.10 China - Market size and forecast 2021-2026 Exhibit 70: Chart on China - Market size and forecast 2021-2026 ($ million) Exhibit 71: Data Table on China - Market size and forecast 2021-2026 ($ million) Exhibit 72: Chart on China - Year-over-year growth 2021-2026 (%) Exhibit 73: Data Table on China - Year-over-year growth 2021-2026 (%) 7.11 Canada - Market size and forecast 2021-2026 Exhibit 74: Chart on Canada - Market size and forecast 2021-2026 ($ million) Exhibit 75: Data Table on Canada - Market size and forecast 2021-2026 ($ million) Exhibit 76: Chart on Canada - Year-over-year growth 2021-2026 (%) Exhibit 77: Data Table on Canada - Year-over-year growth 2021-2026 (%) 7.12 Market opportunity by geography Exhibit 78: Market opportunity by geography ($ million) 8 Drivers, Challenges, and Trends 8.1 Market drivers 8.2 Market challenges 8.3 Impact of drivers and challenges Exhibit 79: Impact of drivers and challenges in 2021 and 2026 8.4 Market trends 9 Vendor Landscape 9.1 Overview 9.2 Vendor landscape Exhibit 80: Overview on Criticality of inputs and Factors of differentiation 9.3 Landscape disruption Exhibit 81: Overview on factors of disruption 9.4 Industry risks Exhibit 82: Impact of key risks on business 10 Vendor Analysis 10.1 Vendors covered Exhibit 83: Vendors covered 10.2 Market positioning of vendors Exhibit 84: Matrix on vendor position and classification 10.3 Alkeus Pharmaceuticals Inc. Exhibit 85: Alkeus Pharmaceuticals Inc. - Overview Exhibit 86: Alkeus Pharmaceuticals Inc. - Product / Service Exhibit 87: Alkeus Pharmaceuticals Inc. - Key offerings 10.4 Allegro Ophthalmics LLC Exhibit 88: Allegro Ophthalmics LLC - Overview Exhibit 89: Allegro Ophthalmics LLC - Product / Service Exhibit 90: Allegro Ophthalmics LLC - Key offerings 10.5 Amgen Inc. Exhibit 91: Amgen Inc. - Overview Exhibit 92: Amgen Inc. - Product / Service Exhibit 93: Amgen Inc. - Key offerings 10.6 Apellis Pharmaceuticals Inc. Exhibit 94: Apellis Pharmaceuticals Inc. - Overview Exhibit 95: Apellis Pharmaceuticals Inc. - Product / Service Exhibit 96: Apellis Pharmaceuticals Inc. - Key offerings 10.7 Bayer AG Exhibit 97: Bayer AG - Overview Exhibit 98: Bayer AG - Business segments Exhibit 99: Bayer AG - Key offerings Exhibit 100: Bayer AG - Segment focus 10.8 F. Hoffmann La Roche Ltd. Exhibit 101: F. Hoffmann La Roche Ltd. - Overview Exhibit 102: F. Hoffmann La Roche Ltd. - Business segments Exhibit 103: F. Hoffmann La Roche Ltd. - Key news Exhibit 104: F. Hoffmann La Roche Ltd. - Key offerings Exhibit 105: F. Hoffmann La Roche Ltd. - Segment focus 10.9 Formycon AG Exhibit 106: Formycon AG - Overview Exhibit 107: Formycon AG - Key offerings 10.10 Novartis AG Exhibit 108: Novartis AG - Overview Exhibit 109: Novartis AG - Business segments Exhibit 110: Novartis AG - Key offerings Exhibit 111: Novartis AG - Segment focus 10.11 Outlook Therapeutics Inc. Exhibit 112: Outlook Therapeutics Inc. - Overview Exhibit 113: Outlook Therapeutics Inc. - Product / Service Exhibit 114: Outlook Therapeutics Inc. - Key offerings 10.12 Reliance Industries Ltd. Exhibit 115: Reliance Industries Ltd. - Overview Exhibit 116: Reliance Industries Ltd. - Business segments Exhibit 117: Reliance Industries Ltd. - Key offerings Exhibit 118: Reliance Industries Ltd. - Segment focus 11 Appendix 11.1 Scope of the report 11.2 Inclusions and exclusions checklist Exhibit 119: Inclusions checklist Exhibit 120: Exclusions checklist 11.3 Currency conversion rates for US$ Exhibit 121: Currency conversion rates for US$ 11.4 Research methodology Exhibit 122: Research methodology Exhibit 123: Validation techniques employed for market sizing Exhibit 124: Information sources 11.5 List of abbreviations Exhibit 125: List of abbreviations About Us Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provide actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios. Contact Technavio Research Jesse Maida Media & Marketing Executive US: +1 844 364 1100 UK: +44 203 893 3200 Email: [email protected] Website: SOURCE Technavio