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DUBLIN--(BUSINESS WIRE)--The "Geographic Atrophy - Market Insights, Epidemiology and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering. The report delivers an in-depth understanding of the GA, historical and forecasted epidemiology as well as the GA market trends in the United States, EU5 (Germany, France, Italy, Spain, and United Kingdom), and Japan. The GA market report provides current treatment practices, emerging drugs, GA market share of the individual therapies, current and forecasted GA market size from 2017 to 2030 segmented by seven major markets. The report also covers current GA treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses underlying potential of the market. Epidemiology The GA epidemiology division provides the insights about historical and current GA patient pool and forecasted trend for each seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken. Key Findings The total prevalent cases of GA in the 7MM were found to be 2,726,453 in 2017 which is expected to grow during the study period, i.e., 2017-2030. The disease epidemiology covered in the report provides historical as well as forecasted GA epidemiology [segmented as Total Prevalent Cases of GA, Total Diagnosed Cases of GA, Total Diagnosed cases of GA by Age Distribution, Total Geographic Atrophy Cases by Visual Impairment, and Total Treated Cases of GA] scenario of GA in the 7MM covering United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom), and Japan from 2017 to 2030. Drug Chapters Drug chapter segment of the GA report encloses the detailed analysis of GA marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the GA clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases. Emerging Drugs Pegcetacoplan (APL-2): Apellis Pharmaceuticals Pegcetacoplan (formerly known as APL-2), is under development by Apellis Pharmaceuticals. It is an investigational, targeted C3 inhibitor designed to regulate excessive complement activation, which can lead to the onset and progression of many serious diseases. Pegcetacoplan is a type of synthetic cyclic peptide conjugated to a polyethylene glycol polymer that binds specifically to C3 and C3b. Currently two phase III trial is ongoing for GA secondary to age-related macular degeneration (AMD). The Phase III program in GA consists of two 600-patient prospective, multicenter, randomized, double-masked, sham-injection controlled trials to assess the efficacy and safety of multiple intravitreal injections of pegcetacoplan in patients with GA, with the goal of enrolling a total of 1,200 patients across approximately 200 sites worldwide. Company refers to these trials as the DERBY and OAKS trials. Company dosed the first patient in Phase III trials in September 2018. It is expected that both trials will be fully enrolled by the end of the first half of 2020 and anticipated announcement of data from these trials will be in mid-2021. In July 2018, the US FDA granted fast track designation to Pegcetacoplan for GA. In November 2014, Apellis Pharmaceuticals entered into an agreement to acquire Potentia Pharmaceuticals. As part of the acquisition agreement, Apellis obtained the necessary intellectual property rights to develop its complement inhibitor drug compound (APL-2) in ophthalmology. Zimura (avacincaptad pegol): Iveric Bio (formerly Ophthotech Corporation) Zimura also known as avacincaptad pegol, is under development by Iveric Bio. It is designed to target and inhibit complement factor C5. Complement factor C5 is a central component of the complement cascade and is believed to be involved in the development and progression of dry AMD. The drug is currently in Phase IIb trial for the treatment of patients with GA Secondary to Dry AMD. However, in January 2020, the Company announced the design of second Phase III clinical trial of Zimura in geographic atrophy secondary to AMD, ISEE2008. In March 18, 2020, the Company announced that due to the COVID-19 pandemic, it had decided to delay the initiation of patient enrollment in the ISEE2008 trial, which was otherwise on track to begin in March 2020. The Company continues to monitor the situation closely in the United States and abroad to determine when enrollment should begin. The Company expected topline 18-month data from its first Phase III clinical trial evaluating Zimura for the treatment of GA secondary to AMD, OPH2003, will be available by the end of the second quarter of 2020. The primary purpose of the 18-month time point is to gather additional safety data. In April 2020, the US FDA granted Fast Track designation to Zimura for the treatment of GA secondary to AMD. ALK-001: Alkeus Pharmaceuticals Alkeus' drug candidate, ALK-001, is a once-a-day oral drug candidate currently being tested for the treatment of GA, which offers a chemically modified version of the vitamin that is designed to reduce the formation of those toxic clumps. ALK-001 works by replacing the C20 hydrogen atoms of vitamin A with deuterium atoms which makes cleavage of the carbon-hydrogen bond more difficult, thereby reduces Vitamin A dimerization and lipofuscin. The company has completed a phase I clinical study (NCT02230228) which was conducted to assess the safety and pharmacokinetics of ALK-001 in healthy volunteer. At present, a Phase III (NCT03845582; Recruiting) multicenter, randomized, double-masked, parallel-group, placebo-controlled study is ongoing to investigate the safety, pharmacokinetics, tolerability, and efficacy of ALK-001 in GA Secondary to Age-related Macular Degeneration. In January 2011, Alkeus Pharmaceuticals and Columbia University entered into a license agreement for a set of potential therapies for the treatment of dry age-related macular degeneration (dry-AMD), Stargardt disease, and other degenerative diseases of the eye. HMR59 (AAVCAGsCD59): Hemera Biosciences HMR59 (HMR-1001; AAVCAGsCD59) is Hemera's one-time gene therapy that works by causing retina cells to continuously produce a soluble protein called CD59 (sCD59) that blocks the final step of the complement cascade. This drug is currently being evaluated in the US FDA approved clinical trials to treat both dry and wet AMD. Macular degeneration is felt to be caused by an over activity of an inflammation cascade called complement. In preclinical testing, AAVCAGsCD59 injected in the vitreous of mice 14 days prior to laser CNV reduced CNV formation by ~60% and MAC formation by ~70%. Hemera Biosciences's expecting to initiate a Phase II (NCT04358471; Not yet recruiting) multi-center trial in June 30, 2020, evaluating intravitreal AAVCAGsCD59 compared to sham injection for the treatment of advanced dry AMD with GA. The one-year key findings of a Phase I dose-escalation trial of HMR59 in dry AMD have shown about a 25% reduction in the growth rate of GA. Market Outlook At present, the therapeutic landscape of GA is devoid of any approved treatment, and to manage this indication, and there is a substantial unmet need for a therapy to slow its worsening. The pathophysiology of GA is poorly understood. Although correlative evidence for complement, inflammation, and GA pathology has been found in human tissues, a causative role for complement, or for inflammation in general, can be demonstrated only in appropriate preclinical models of GA. The current standard of Care is observation, and besides high doses of antioxidant vitamin, zinc supplements are found to produce a beneficial effect in slowing the progression of d-AMD. In the absence of any treatment and because of a poor correlation between BCVA and GA lesions or progression, a multimodal imaging approach is necessary to better follow up GA patients. Several companies tried to develop a drug for this condition, but failed. One such example is Lampalizumab (Genentech/Roche). This drug blocks a region on factor D that is an important binding site for factor B. As a result, factor B cannot be cleaved therefore inhibits the alternate complement pathway. In September 2017, press releases from Roche and Genentech announced that two phase III clinical trials of lampalizumab (Spectri and Chroma), failed to meet their primary end point of reducing mean change in GA lesion area after 48 weeks when compared with sham treatment. At present several pharmaceutical companies are working for the development of novel approach to treat this condition. Key players like Apellis Pharmaceuticals (Pegcetacoplan; APL-2), Alkeus Pharmaceuticals (ALK-001), Iveric bio (formerly Ophthotech Corporation; Zimura), Genentech (Roche; RO7171009; RG6147), Ionis Pharmaceuticals./ Roche (IONIS-FB-LRx), Hemera Biosciences (HMR59), Allegro Ophthalmics(Risuteganib), Stealth BioTherapeutics (Elamipretide), Janssen Research & Development (Palucorcel; CNTO 2476), Regenerative Patch Technologies (CPCB-RPE1), CellCure Neurosciences (OpRegen), Gyroscope Therapeutics (GT005), and others. Key Findings The therapeutic market of GA in the seven major markets was USD 276 million in 2017 which is expected to increase during study period (2017-2030). According to the estimates, the highest market size of GA is found in the United States followed by the UK and France. In case of clinical trials of emerging therapies, no active companies in this space currently focusing on Japan and also no visibility around the launch scenarios in Japan hence emerging therapies launch is not considered in Japan. The United States Market Outlook In 2017, the total market size of GA therapies was USD 181 million in the United States which is expected to increase in the study period (2017-2030). EU-5 Countries: Market Outlook In 2017, the total market size of GA therapies was USD 83 million in the EU-5 countries which is expected to increase in the study period (2017-2030). Japan Market Outlook The total market size of GA therapies in Japan was USD 12 million in 2017. Pipeline Development Activities The drugs which are in pipeline include: 1. Pegcetacoplan (APL-2) (Apellis Pharmaceuticals): Phase III 2. ALK-001 (Alkeus Pharmaceuticals): Phase III 3. Zimura (avacincaptad pegol) [Iveric bio (formerly Ophthotech Corporation)]: Phase IIb 4. RO7171009 (RG6147) [Roche (Genentech)]: Phase II 5. IONIS-FB-LRx (Ionis Pharmaceuticals./Roche): Phase II 6. AAVCAGsCD59 (HMR59) (Hemera Biosciences): Phase II 7. Risuteganib (Allegro Ophthalmics): Phase II 8. Elamipretide (Stealth BioTherapeutics): Phase II 9. Palucorcel (CNTO 2476) (Janssen Research & Development): Phase II Drugs Uptake HMR59 (Gene Therapy) expected to generate highest market size owing to one time treatment approach, expected premium pricing and impressive early stage efficacy data. Furthermore, there are no significant differences seen in the available efficacy results of APL-2 and Zimura; but Zimura owing to better safety profile expected to have slight edge over APL-2. So, Zimura is expected to generate second highest revenue in the total GA market. Access and Reimbursement Scenario KOL Views To keep up with current market trends, we take KOLs and SME's opinion working in GA domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or GA market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs. Prof. Medical Director, Department of Ophthalmology, University of Bonn, Germany Views: Competitive Intelligence Analysis The publisher performs Competitive and Market Intelligence analysis of the GA Market by using various Competitive Intelligence tools that includes - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability. Scope of the Report Report Highlights For more information about this drug pipelines report visit https://www.researchandmarkets.com/r/yu829q

Answer: Global Geographic Atrophy Industry Assessment and Epidemiology Forecast to 2030 - ResearchAndMarkets.com