Latest news with #Retinopathy
Associated Press
30-04-2025
- Health
- Associated Press
RetinAI and FVS Announce CE-MDR Certification for Co-developed AI-based Diabetic Retinopathy Screening Algorithm, LuxIA®
BERN, Switzerland and MADRID, April 30, 2025 (GLOBE NEWSWIRE) -- RetinAI US Inc. (RetinAI) and Fundación Ver Salud (FVS) are pleased to jointly announce that LuxIA®, their co-developed innovative AI algorithm for Diabetic Retinopathy (DR) screening, has successfully received CE-MDR certification as a Class IIb medical device under the European Union Medical Device Regulation (EU MDR 2017/745). The certification was granted through Ikerian AG, RetinAI's parent company. LuxIA is designed to screen adult diabetic patients for more-than-mild diabetic retinopathy (mtmDR). This indication for use provides critical support for ophthalmologists, general practitioners and trained healthcare professionals across the European Union to achieve an earlier diagnosis of mtmDR, a vision-threatening eye disease. This new certification demonstrates the strong collaboration between FVS and RetinAI, emphasizing both entities' commitment to deliver AI-driven tools that meet stringent regulatory standards and significantly enhance patient management and clinical outcomes. The device is indicated for processing digital 45-degree colour fundus images from NW200, NW400 or equivalent Topcon cameras, ensuring seamless placement into existing clinical workflows. Together with RetinAI's existing portfolio of AI-based OCT analysis solutions, LuxIA complements a comprehensive suite of clinically validated, CE-certified AI modules focused on ophthalmology. Dr. Carlos Ciller, CEO and co-founder of RetinAI, commented: 'Receiving CE-MDR certification for LuxIA underscores our shared commitment with FVS to advance leading-edge ophthalmic care to patients through reliable and impactful AI technology. This milestone is pivotal, enabling healthcare providers to improve patient management and outcomes for diabetic retinopathy across Europe, reinforcing our joint mission of transforming vision care through innovation.' Dr. Juan Donate, MD, President of Fundación Ver Salud stated: 'We are excited about the newly received certification and look forward to the significant impact LuxIA will have in the European ophthalmology market. AI-driven screening solutions are critical to improving patient care, and we anticipate LuxIA will play a central role in achieving this.' For further information or to request a demonstration of LuxIA and other ophthalmic solutions from FVS and RetinAI, please visit For further information please contact: At the company Carlos Ciller, PhD, CEO - Ikerian AG and RetinAI Inc US [email protected], [email protected] Media enquiries Sue Charles, Charles Consultants - [email protected] +44 (0)7968726585 About Ikerian AG and RetinAI Inc. US Established in 2017, Ikerian AG (formerly RetinAI Medical AG) and its subsidiary, RetinAI U.S. Inc. ('Ikerian', 'RetinAI' and, together, 'the company'), develops software solutions to accelerate clinical, research and pharmaceutical workflows globally using advanced machine learning and computer vision, across ophthalmology, neurodegenerative disorders, vascular conditions, and rare diseases. RetinAI builds tools to collect, organize and analyze health data from the eyes, enabling healthcare professionals to make the right decisions sooner in healthcare. RetinAI's international team leverages its clinical, technical, and scientific expertise to foster the transition from reactive to preventive medicine for severe eye diseases. Follow us on LinkedInand About FVS FVS is a non-profit organization focused on training, research, and medical innovation, particularly in the field of ophthalmology. Its mission is to develop solutions that promote better clinical outcomes and enhance the quality of patient care. Follow us on LinkedIn and X
Globe and Mail
12-03-2025
- Business
- Globe and Mail
Diabetic Retinopathy Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
DelveInsight's, ' Diabetic Retinopathy Pipeline Insight ' report provides comprehensive insights about 50+ companies and 55+ pipeline drugs in the Diabetic Retinopathy pipeline landscape. It covers the Diabetic Retinopathy pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Diabetic Retinopathy pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Explore the comprehensive insights by DelveInsight and stay ahead in understanding the Diabetic Retinopathy Treatment Landscape. Click here to read more @ Diabetic Retinopathy Pipeline Outlook Key Takeaways from the Diabetic Retinopathy Pipeline Report In March 2025:- Vantage Biosciences Ltd announced a study to evaluate the Efficacy and Safety of Orally Administered VX-01 in Diabetic Retinopathy of Non-Proliferative Type (NPDR). In March 2025:- Invirsa Inc. announced a phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during a 12-week dosing period in subjects with non-center involved DME (NCIDME) associated with NPDR [Part 1] and during an 8-week dosing period in subjects with center-involved DME (CIDME) associated with NPDR [Part 1]. In March 2025:- Incepta Pharmaceuticals Ltd conducted a study to to Compare Efficacy & Safety Between Ranibizumab 10mg/ml Injection of Incepta and Lucentis in Patients With Diabetic Macular Edema by ITV Injection. In March 2025:- EyePoint Pharmaceuticals Inc. announced a study of Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Diabetic Macular Edema (DME). DelveInsight's Diabetic Retinopathy pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline therapies for Diabetic Retinopathy treatment. The leading Diabetic Retinopathy Companies such as Kodiak Sciences, Novartis, Regenxbio Inc., OcuTerra Therapeutics, Ocular Therapeutix, Bayer, RemeGen, Roche, Ocuphire Pharma, Adverum Biotechnologies, Boehringer Ingelheim, and others. Promising Diabetic Retinopathy Pipeline Therapies such as Runcaciguat (BAY1101042), OTT166, COLIRIOBCN070660, Brimonidine, and others. Discover groundbreaking developments in Diabetic Retinopathy therapies! Gain in-depth knowledge of key Diabetic Retinopathy clinical trials, emerging drugs, and market opportunities @ Diabetic Retinopathy Clinical Trials Assessment Diabetic Retinopathy Emerging Drugs Profile Tarcocimab tedromer: Kodiak Sciences Tarcocimab is an investigational anti-VEGF therapy built on Kodiak's proprietary Antibody Biopolymer Conjugate (""ABC"") Platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing available agents. Kodiak's objective with tarcocimab is to enable earlier treatment and prevention of vision loss for patients with diabetic retinopathy and to develop a new durability agent to improve outcomes for patients with retinal vascular diseases. Currently, the drug is in Phase III stage of its clinical trial for the treatment of diabetic retinopathy. OTT166: Ocuterra Therapeutics Nesvategrast (OTT166) is an investigational, novel, patented, potent and selective small molecule RGD integrin inhibitor designed with purpose engineering to have an optimum balance of physiochemical properties to allow it to distribute to the retina in high concentrations after topical (eye drop) administration to the eye. In preclinical studies, nesvategrast selectively inhibited key RGD integrin subtypes, including αvβ3, to regulate cellular responses to VEGF and other growth factors known to contribute to development and progression of diabetic retinopathy and other ocular diseases. In early clinical trials in patients with diabetic retinal disease, nesvategrast eye drops have demonstrated preliminary evidence of tolerability and biological activity. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Diabetic retinopathy. APX3330: Apexian Pharmaceuticals APX3330 is a first-in-class, small molecule, oral inhibitor of the transcription factor regulator Ref-1 (reduction-oxidation effector factor-1). With a novel dual mechanism of action, APX3330 blocks the downstream pathways those involving angiogenesis (VEGF) and inflammation (NFkB) to decrease abnormal activation of both angiogenesis, and of inflammatory pathways that are implicated across several ocular diseases, including DR, DME, and age-related macular degeneration (AMD). APX3330 has shown a favorable safety and tolerability profile in 12 clinical trials conducted in healthy, hepatitis, cancer, and diabetic subjects. Currently, the drug is in Phase II stage of its clinical trial for the treatment of diabetic retinopathy. OTX-TKI: Ocular Therapeutix OTX-TKI is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Diabetic retinopathy. The Diabetic Retinopathy Pipeline report provides insights into The report provides detailed insights about companies that are developing therapies for the treatment of Diabetic Retinopathy with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Diabetic Retinopathy Treatment. Diabetic Retinopathy Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Diabetic Retinopathy Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Diabetic Retinopathy market Stay informed about the Diabetic Retinopathy pipeline trends! Uncover critical updates on therapeutic innovations and their potential impact on patients and the healthcare industry @ Diabetic Retinopathy Unmet Needs Diabetic Retinopathy Companies Kodiak Sciences, Novartis, Regenxbio Inc., OcuTerra Therapeutics, Ocular Therapeutix, Bayer, RemeGen, Roche, Ocuphire Pharma, Adverum Biotechnologies, Boehringer Ingelheim, and others. Diabetic Retinopathy pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Diabetic Retinopathy Pipeline Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Transform your understanding of the Diabetic Retinopathy Pipeline! See the latest progress in drug development and clinical research @ Diabetic Retinopathy Market Drivers and Barriers, and Future Perspectives Scope of the Diabetic Retinopathy Pipeline Report Coverage- Global Diabetic Retinopathy Companies- Kodiak Sciences, Novartis, Regenxbio Inc., OcuTerra Therapeutics, Ocular Therapeutix, Bayer, RemeGen, Roche, Ocuphire Pharma, Adverum Biotechnologies, Boehringer Ingelheim, and others. Diabetic Retinopathy Pipeline Therapies- Runcaciguat (BAY1101042), OTT166, COLIRIOBCN070660, Brimonidine, and others. Diabetic Retinopathy Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Diabetic Retinopathy Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Dive deep into rich insights for new drugs for Diabetic Retinopathy Treatment, Visit @ Diabetic Retinopathy Market Drivers and Barriers, and Future Perspective Table of Content Introduction Executive Summary Diabetic Retinopathy: Overview Pipeline Therapeutics Therapeutic Assessment Diabetic Retinopathy– DelveInsight's Analytical Perspective Late Stage Products (Phase III) KSI-301: Kodiak Sciences Drug profiles in the detailed report….. Mid Stage Products (Phase II) RGX 314: Regenxbio Inc Drug profiles in the detailed report….. Early Stage Products (Phase I) OTX-TKI: Ocular Therapeutix Drug profiles in the detailed report….. Preclinical and Discovery Stage Products Drug name: Company name Drug profiles in the detailed report….. Inactive Products Diabetic Retinopathy Key Companies Diabetic Retinopathy Key Products Diabetic Retinopathy- Unmet Needs Diabetic Retinopathy- Market Drivers and Barriers Diabetic Retinopathy- Future Perspectives and Conclusion Diabetic Retinopathy Analyst Views Diabetic Retinopathy Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. 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