A Randomized Controlled, Double-Masked, Crossover Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of 1.0 Mg Luminate® (Alg-1001) As A Treatment For Non-Exudative Macular Degeneration

To evaluate the safety and exploratory efficacy of 1.0mg of Luminate® in patients with Intermediate Non-Exudative Macular Degeneration

Start Date01 Aug 2017

Sponsor / Collaborator

Allegro Ophthalmics LLC

NCT02435862

/ CompletedPhase 2

Protocol PVD-202: A Phase 2, Randomized, Double-Masked, Placebo-Controlled Multicenter Clinical Trial Designed to Evaluate the Safety and Efficacy Study of Luminate® in Inducing PVD in Non-Proliferative Diabetic Retinopathy

A Phase 2, Randomized, Double-masked, Placebo-controlled Multicenter Clinical Trial Designed to Evaluate the Safety and Efficacy of Luminate in Inducing PVD in Subjects with Non-Proliferative Diabetic Retinopathy.

Start Date01 Feb 2015

Sponsor / Collaborator

Allegro Ophthalmics LLC

[+2]

NCT02348918

/ CompletedPhase 2

A Phase 2 Randomized, Controlled, Double-Masked, Multicenter Clinical Trial Designed to Evaluate the Safety and Exploratory Efficacy of Luminate® (ALG-1001) as Compared to Avastin® in the Treatment of Diabetic Macular Edema (DME)

A Phase 2 Multi center, Randomized, Controlled, Double-Masked Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of Luminate® (Alg-1001) As Compared To Avastin® In The Treatment Of Diabetic Macular Edema

Start Date13 Oct 2014

Sponsor / Collaborator

Allegro Ophthalmics LLC

[+2]

100 Clinical Results associated with Risuteganib

100 Translational Medicine associated with Risuteganib

100 Patents (Medical) associated with Risuteganib

Literatures (Medical) associated with Risuteganib

01 Mar 2024·Journal of ethnopharmacology

Anti-inflammatory effect and mechanism of active parts of Artemisia mongolica in LPS-induced Raw264.7 cells based on network pharmacology analysis.

Article

Author: Zhu, ZiWei ; Wang, Fangsheng ; Liu, Liu ; Aisa, Haji Akber ; Xin, Xuelei

ETHNOPHARMACOLOGICAL RELEVANCE:

Artemisia mongolica is well known for its use in folk medicine, it is commonly used to alleviate a variety of diseases associated with inflammation, such as laryngitis, tonsillitis, headaches and hepatitis in northwest China. However, its anti-inflammatory mechanism is still unknown.

AIM OF THE STUDY:

The most potential anti-inflammatory part (AMPA) was identified by screening individual parts of A. Mongolica. After the network pharmacological analysis, the anti-inflammation effects and molecular mechanisms of AMPA were evaluated in RAW264.7 cells induced by LPS.

MATERIALS AND METHODS:

AMPA was chosen as the most anti-inflammatory of the A. Mongolica, as measured by the effect of each part of the A. Mongolica on NO and COX-2. The chemical composition of AMPA was identified using HPLC-Q-TOF-MS/MS, and targets of bioactive chemicals and targets related to inflammation were found using open-source databases. The "Compound-targets" network and PPI network were established by combining compounds and overlapped targets, and targets in the PPI networks were analyzed by GO and KEGG enrichment. The RAW26.7 cells induced by LPS were used as a model of inflammation examination. MTT assay was performed to assess the cytotoxicity of AMPA on LPS-induced RAW264.7 cells. The level of NO was measured by the Griess method while the inflammatory factors were detected by ELISA. The protein expression levels of iNOS, COX-2, MAPK, NF-κB signaling pathway and AMPK/Nrf2-related proteins were determined by Western blot. The results of nuclear translocation of p65 and Nrf2 were analyzed by immunofluorescence assay.

RESULTS:

A total of 18 compounds with potential bioactivity were identified, and after intersecting 640 compound-predicted targets and 1608 inflammation targets, the compounds and intersected targets were utilized to structure "compound-target" and PPI networks. Among AMPA, AM6, AM7, AM11, AM8 and AM1 compounds were essential in the "compound-targets" network, meanwhile, TNF, RELA, MAPK1, NOS2, PRKAG, and PTGS2 targets play important roles in the PPI network. The top 10 terms and pathways were obtained based on GO and KEGG. The cell experiments show that 50 μg/mL was the maximum concentration of AMPA without cytotoxicity in the LPS-induced RAW264.7 cell model. When compared with the LPS group, AMPA treatment not only effectively suppressed the generation of NO, TNF-α, IL-6, PGE2, IL-1β and MCP-1 in LPS-induced RAW264.7 cells, but also down-regulated the expression of COX-2, iNOS and the protein levels p-ERK, p-p38, p-IκB-α and p-p65, inhibited the nuclear translocation of p65. Furthermore, the expression levels of p-LKB1, p-AMPK, Nrf2 and HO-1 proteins were up-regulated and Nrf2 nuclear translocation was promoted.

CONCLUSION:

AMPA should be considered an anti-inflammatory agent for the results of network pharmacology and in vitro, which could inhibit the MAPK pathway and NF-κB pathway and activate the AMPK/Nrf2 pathway in LPS-stimulated RAW264.7 cells.

01 Apr 2023·Acta pharmacologica Sinica

JP1, a polypeptide specifically targeting integrin αVβ3, ameliorates choroidal neovascularization and diabetic retinopathy in mice

Article

Author: Liu, Qing-Huai ; Zhou, Jian-Wei ; Xie, Zhan ; Wu, Xin-Jing ; Cui, Jia-Hua ; Cheng, Rui-Wen ; Yuan, Song-Tao

Anti-vascular endothelial growth factor (VEGF) drugs have revolutionized the treatment of neovascular eye diseases, but responses are incomplete in some patients. Recent evidence shows that integrins are involved in the pathogenesis of neovascular age-related macular degeneration and diabetic retinopathy. JP1, derived from an optimized seven-amino-acid fragment of JWA protein, is a polypeptide specifically targeting integrin αVβ3. In this study we evaluated the efficacy of JP1 on laser-induced choroidal neovascularization (CNV) and retinal vascular leakage. CNV mice received a single intravitreal (IVT) injection of JP1 (10, 20, 40 µg) or ranibizumab (RBZ, 10 µg). We showed that JP1 injection dose-dependently inhibited laser-induced CNV; the effect of RBZ was comparable to that of 20 µg JP1; a combined IVT injection of JP1 (20 μg) and RBZ (5 μg) exerted a synergistic effect on CNV. In the 3rd month after streptozotocin injection, diabetic mice receiving IVT injection of JP1 (40 µg) or RBZ (10 µg) once a week for 4 weeks showed significantly suppressed retinal vascular leakage. In both in vivo and in vitro experiments, JP1 counteracted oxidative stress and inflammation via inhibiting ROS/NF-κB signaling in microglial cells, and angiogenesis via modulating MEK1/2-SP1-integrin αVβ3 and TRIM25-SP1-MMP2 axes in vascular endothelial cells. In addition, intraperitoneal injection of JP1 (1, 5 or 10 mg) once every other day for 3 times also dose-dependently inhibited CNV. After intraperitoneal injection of FITC-labeled JP1 (FITC-JP1) or FITC in laser-induced CNV mice, the fluorescence intensity in the CNV lesion was markedly increased in FITC-JP1 group, compared with that in FITC group, confirming that JP1 could penetrate the blood-retinal barrier to target CNV lesion. We conclude that JP1 can be used to design novel CNV-targeting therapeutic agents that may replace current invasive intraocular injections.

01 Nov 2022·Ophthalmology. Retina

Impact of Baseline Quantitative OCT Features on Response to Risuteganib for the Treatment of Dry Age-Related Macular Degeneration

Article

Author: Jaffe, Glenn J ; Farsiu, Sina ; Srivastava, Sunil K ; Karageozian, Vicken ; Sarayba, Melvin ; Kaiser, Peter K ; Abraham, Joseph R ; Chiu, Stephanie J ; Loo, Jessica ; Ehlers, Justis P ; Bouckaert, Laurens

OBJECTIVE:

The purpose of the study was to perform a post hoc analysis to explore the effect of baseline anatomic characteristics identified on OCT on best-corrected visual acuity (BCVA) responses to risuteganib from the completed phase II study in subjects with dry age-related macular degeneration (AMD).

DESIGN:

Post hoc analysis of a randomized, double-masked, placebo-controlled, phase II study.

SUBJECTS:

Eyes with intermediate dry AMD with BCVA between 20/40 and 20/200. Patients with concurrent vision-influencing or macula-obscuring ocular pathologies were excluded.

METHODS:

Patients were randomized to receive a 1-mg intravitreal risuteganib injection or a sham injection at baseline. A second 1-mg intravitreal injection of risuteganib was given at week 16 to those in the treatment arm. Two independent, masked reading centers evaluated the baseline anatomic characteristics on OCT to explore features associated with positive responses to risuteganib.

MAIN OUTCOME MEASURES:

Treatment response was defined as a gain of ≥ 8 letters in BCVA from baseline to week 28 in the treatment arm, compared with baseline to week 12 in the sham group. Anatomic parameters, measured by retinal segmentation platforms, including measures of retinal thickness were compared between the responders and nonresponders to risuteganib.

RESULTS:

Thirty-nine patients completed the study and underwent analysis. In the treatment arm, 48% of eyes demonstrated treatment responses, compared with 7% in the sham group. In the quantitative anatomic assessment, enhanced ellipsoid integrity, greater outer retinal thickness, and decreased geographic atrophy were associated with increased BCVA gains to risuteganib.

CONCLUSIONS:

This post hoc analysis demonstrated that baseline OCT features may help determine the likelihood of a functional response to risuteganib. The characterization of higher-order OCT features may provide important information regarding biomarkers for treatment response and could facilitate optimized clinical trial enrollment and enrichment.

News (Medical) associated with Risuteganib

23 Jan 2025

·www.prnewswire.com

70+ Key Companies Advancing in Dry Age-Related Macular Degeneration Clinical Trial Therapeutic Space | DelveInsight

Dry macular degeneration is a common eye disorder among people aged above 50 years. It causes blurred or reduced central vision due to thinning of the macula. The macula is the part of the retina responsible for clear vision in a direct line of sight. The pharmaceutical industry is increasingly focused on developing pathway-based therapies for dry AMD, with promising treatments like ALK-001 and LBS-008 in trials, though a combination approach may be needed to fully inhibit disease progression. LAS VEGAS, Jan. 23, 2025 /PRNewswire/ -- DelveInsight's ' Dry Age-Related Macular Degeneration Pipeline Insight 2025 ' report provides comprehensive global coverage of pipeline dry AMD therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the dry AMD pipeline domain. Key Takeaways from the Dry Age-Related Macular Degeneration Pipeline Report DelveInsight's dry AMD pipeline report depicts a robust space with 70+ active players working to develop 80+ pipeline therapies for dry AMD treatment. Key dry AMD companies such as Alkeus Pharmaceuticals, Dobecure, Belite Bio, Cognition Therapeutics, Aviceda Therapeutics, Stealth BioTherapeutics, Allergo Ophthalmics, Annexon, Inc., Johnson & Johnson, InflammX Therapeutics, Lineage Cell Therapeutics, Ionis Pharmaceuticals, Evergreen Therapeutics, Inc., Alexion, Luxa Biotechnology, Astellas Pharma, OliX Pharmaceuticals, Hoffmann-La Roche, Boehringer Ingelheim, Eyevensys and others are evaluating new dry AMD drugs to improve the treatment landscape. Promising dry AMD pipeline therapies such as ALK-001, Etamsylate, Tinlarebant (LBS-008), CT1812, AVD-104, Elamipretide, Risuteganib, ANX 007, JNJ 81201887, Xiflam, OpRegen, IONIS-FB-LRx, EG-301, ALXN2040, RPESC-RPE-4W, MA09-hRPE, OLX301A, RO7303359, BI 771716, EYS 611 and others are under different phases of dry AMD clinical trials. In December 2024, Galimedix Therapeutics announced the initiation of its Phase II eDREAM study to assess the safety and efficacy of GAL-101 eye drops in patients with dry age-related macular degeneration. In December 2024, Ocugen, Inc. announced that the Data and Safety Monitoring Board (DSMB) for the OCU410 ArMaDa clinical trial recently convened and approved continuation of the second phase of the Phase 1/2 study. OCU410 (AAV5-hRORA) is a novel modifier gene therapy candidate being developed for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD). In November 2024, Ocugen, Inc. announced positive preliminary efficacy and safety data from the Phase I dose-escalation portion of the Phase 1/2 OCU410 ArMaDa clinical trial for geographic atrophy (GA), secondary to dry age-related macular degeneration (dAMD). Key findings include: no drug-related serious adverse events, reduced lesion growth, preservation of retinal tissue, and most importantly there was a positive effect on the functional visual measure of low luminance visual acuity (LLVA). In October 2024, Eyestem Research, focused on creating scalable cell therapies for incurable diseases, had announced a positive outcome of the Drug Safety Monitoring Board (DSMB) review for the first cohort of its Phase one trial to treat Geographic Atrophy secondary to Dry Age-related Macular Degeneration, marking a milestone for Indian science and medical research. In September 2024, Stealth BioTherapeutics Inc. announced the presentation of new bevemipretide (SBT-272) preclinical data demonstrating topical ocular delivery to the retina with protective effects observed in models of AMD. In June 2024, Stealth BioTherapeutics Inc. announced that it has enrolled and dosed its first patient in the ReNEW trial as part of its Phase III clinical program for elamipretide in patients with dry age-related macular degeneration (dry AMD). The program consists of the two Phase III trials, ReNEW and ReGAIN. Both trials will evaluate the efficacy, safety, and pharmacokinetics of daily subcutaneous injections of elamipretide in participants with dry AMD. In April 2024, Eyestem received approval from India's Central Drugs Standards Control Organisation (CDSCO) to commence human trials for Eyecyte RPE, a potential treatment for geographic atrophy arising from dry age-related macular degeneration (AMD). Request a sample and discover the recent advances in dry AMD treatment drugs @ Dry Age-Related Macular Degeneration Pipeline Report The dry AMD pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage dry AMD drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the dry AMD clinical trial landscape. Dry Age-Related Macular Degeneration Overview Age-related macular degeneration (AMD) is one of the top four causes of blindness in older adults and the leading cause of irreversible blindness in developed countries. Around 170 million people globally are affected by AMD, making it the third most common cause of vision loss worldwide. Dry AMD typically progresses slowly, but wet AMD can cause severe visual impairment within days or weeks of onset. In the early stages of AMD, there are no noticeable symptoms, though an ophthalmologist can detect drusen before symptoms arise. Some individuals experience slight vision changes during the intermediate stage, but many remain symptom-free. Others may notice dark or grey spots in their central vision or have difficulty transitioning from bright to dim lighting. Clinicians currently use various imaging techniques to monitor changes in the retina, retinal pigment epithelium (RPE), and choroid, including fundus exams, color fundus photography, fundus autofluorescence (FAF), optical coherence tomography (OCT), and infrared reflectance imaging. Over the past two decades, OCT has significantly advanced the early detection, monitoring, and treatment assessment of dry AMD. Modern spectral-domain OCT (SD-OCT) systems provide detailed cross-sectional and volumetric views of the retina, enabling clinicians to visualize, measure, and monitor retinal layers, RPE, hyperreflective foci, geographic atrophy (GA), and drusen. While SD-OCT remains the standard of care, emerging technologies like polarization-sensitive OCT (PS-OCT), which offers tissue-selective imaging, may revolutionize AMD research and clinical practices. Currently, no approved treatments exist for dry AMD. Management involves regular monitoring, timely detection of visual deterioration, appropriate rehabilitation, and early identification of choroidal neovascularization (CNV). Research is underway to explore therapeutic strategies to prevent AMD, slow its progression, or restore vision. Potential treatments include lifestyle and behavioral changes, age-related eye disease study (AREDS) supplements, visual cycle modulators, anti-inflammatory agents, complement inhibitors, gene therapy, cell-based therapies, and approaches to reduce toxic by-products. Find out more about dry AMD treatment drugs @ Drugs for Dry Age-Related Macular Degeneration Treatment A snapshot of the Dry Age-Related Macular Degeneration Pipeline Drugs mentioned in the report: Learn more about the emerging dry AMD pipeline therapies @ Dry Age-Related Macular Degeneration Clinical Trials Dry Age-Related Macular Degeneration Therapeutics Assessment The dry AMD pipeline report proffers an integral view of the dry AMD emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Dry Age-Related Macular Degeneration Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Dimerisation inhibitors, Vitamin A replacements, RBP4 protein inhibitors, Sigma-2 receptor antagonists, Complement factor H stimulants, Macrophage inhibitors, Cell replacements, RNA interference, Key Dry Age-Related Macular Degeneration Companies: Alkeus Pharmaceuticals, Dobecure, Belite Bio, Cognition Therapeutics, Aviceda Therapeutics, Stealth BioTherapeutics, Allergo Ophthalmics, Annexon, Inc., Johnson & Johnson, InflammX Therapeutics, Lineage Cell Therapeutics, Ionis Pharmaceuticals, Evergreen Therapeutics, Inc., Alexion, Luxa Biotechnology, Astellas Pharma, OliX Pharmaceuticals, Hoffmann-La Roche, Boehringer Ingelheim, Eyevensys and others Key Dry Age-Related Macular Degeneration Pipeline Therapies: ALK-001, Etamsylate, Tinlarebant (LBS-008), CT1812, AVD-104, Elamipretide, Risuteganib, ANX 007, JNJ 81201887, Xiflam, OpRegen, IONIS-FB-LRx, EG-301, ALXN2040, RPESC-RPE-4W, MA09-hRPE, OLX301A, RO7303359, BI 771716, EYS 611 and others. Dive deep into rich insights for new drugs for dry AMD treatment, visit @ Dry Age-Related Macular Degeneration Drugs Table of Contents For further information on the dry AMD pipeline therapeutics, reach out @ Dry Age-Related Macular Degeneration Treatment Drugs Related Reports Dry Age-Related Macular Degeneration Market Dry Age-Related Macular Degeneration Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key dry AMD companies including Alkeus Pharmaceuticals, Belite Bio, Aviceda Therapeutics, Johnson & Johnson Innovative Medicine, Allegro Ophthalmics, Lineage Cell Therapeutics (CellCure Neurosciences), Roche, Cognition Therapeutics, Stealth BioTherapeutics, Evergreen Therapeutics, Annexon Biosciences, NGM Biopharmaceuticals, AstraZeneca, Alexion Pharmaceuticals, Ionis Pharmaceuticals, Novartis, Regenerative Patch Technologies, among others. Dry Age-related Macular Degeneration Epidemiology Forecast Dry Age-related Macular Degeneration Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted dry AMD epidemiology in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Age-related Macular Degeneration Market Age-related Macular Degeneration Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key AMD companies including Regeneron Pharmaceuticals, Novartis, Roche, Opthea Limited, Kodiak Sciences Inc., REGENXBIO, Alkahest Inc, Graybug Vision, Ribomic USA Inc, Outlook Therapeutics, Inc., Unity Biotechnology, Inc, PanOptica, Inc., Clearside Biomedical, Alexion Pharmaceuticals, AstraZeneca, Evergreen Therapeutics, Alkeus Pharmaceuticals, Stealth BioTherapeutics, CellCure Neurosciences, Regenerative Patch Technologies, Allegro Ophthalmics, Annexon Biosciences, NGM Biopharmaceuticals, Ionis Pharmaceuticals, Apellis Pharmaceuticals, Iveric Bio, Gyroscope Therapeutics, Luxa Biotechnology, Gemini Therapeutics , among others. Wet Age-related Macular Degeneration Market Wet Age-related Macular Degeneration Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Wet Age-related Macular Degeneration companies including EyePoint Pharmaceuticals, Inc., AbbVie, Caregen Co. Ltd., Exegenesis Bio, Shanghai Henlius Biotech, Skyline Therapeutics, 4D Molecular Therapeutics, Ocugenix Corporation, Adverum Biotechnologies, Inc., Ashvattha Therapeutics, Inc., AiViva BioPharma, Inc., Ocular Therapeutix, Inc., Clearside Biomedical, Inc., Hoffmann-La Roche, Kyowa Kirin, Inc., Opthea Limited, AffaMed Therapeutics Limited, EyeBiotech Ltd., Novartis , among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Phase 3Phase 2

20 Feb 2024

·www.pharmaceutical-technology.com

Singapore HSA accepts AffaMed’s NDA for ocular treatment

DEXTENZA is a corticosteroid intracanalicular insert designed to be placed into the punctum and canaliculus of the eye. Credit: 4 PM production/Shutterstock.com. The Singapore Health Sciences Authority (HSA) has accepted the new drug application (NDA) for AffaMed Therapeutics’ DEXTENZA (0.4 mg dexamethasone ophthalmic insert) to treat ocular inflammation and pain. The treatment is indicated following ophthalmic surgical procedures and for ocular itching linked to allergic conjunctivitis. This marks a significant milestone for the company as it seeks to expand the reach of DEXTENZA, which is already approved in the US and listed in Macau for similar indications. DEXTENZA is a corticosteroid intracanalicular insert designed to be placed into the punctum and canaliculus of the eye. It offers dexamethasone to the ocular surface for up to 30 days without the use of preservatives. See Also: US FDA accepts review of argenx’s VYVGART Hytrulo for CIDP Iovance’s Amtagvi for melanoma treatment gains FDA approval The insert’s unique feature is its reabsorption, enabling it to exit the nasolacrimal system on its own. AffaMed is progressing the development of DEXTENZA as the first physician-administered, sustained-release intracanalicular insert available to patients in ASEAN countries and Greater China. The convenience of a single administration that delivers a preservative-free dose of dexamethasone over 30 days provides significant benefits over existing therapies, which typically require multiple daily eye-drop applications. The company has also initiated a registrational trial to assess the efficacy and safety of DEXTENZA against a placebo vehicle for treating inflammation and pain post-cataract surgery in mainland China. Topline data from this trial is anticipated in the third quarter of 2024. AffaMed entered a licensing agreement with Ocular Therapeutix in October 2020 in a strategic move to broaden its market. The agreement covers the development and commercialisation of DEXTENZA in South Korea, Greater China and some ASEAN [Association of South East Asian Nations] markets. AffaMed CEO Vijay Karwal stated: “As the first NDA filing by AffaMed, the acceptance of our DEXTENZA NDA in Singapore represents an important milestone in our company’s journey to successfully advance much-needed therapeutic candidates through regulatory pathways across multiple regions in Asia. “DEXTENZA is the lead candidate in AffaMed’s innovative and differentiated ophthalmology pipeline and represents an important advancement in the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis.” In September 2023, the company received approval from China’s National Medical Products Administration for a clinical trial application of risuteganib (Luminate ) to treat intermediate dry age-related macular degeneration.

License out/inNDADrug Approval

25 Sep 2023

·www.prnewswire.com

AffaMed Therapeutics Announces Clinical Trial Application Approval in Mainland China for Risuteganib (Luminate®) First-in-Class Candidate for the Treatment of Intermediate Dry AMD

SHANGHAI, Sept. 25, 2023 /PRNewswire/ -- AffaMed Therapeutics ("AffaMed"), a global biotechnology company dedicated to developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmological, neurological and psychiatric disorders, today announced that China's National Medical Products Administration has approved AffaMed's Clinical Trial Application (CTA) to investigate the efficacy and safety of Risuteganib (Luminate®), its First-in-Class, new Mechanism of Action ophthalmic intravitreal injectable product candidate for the treatment of Intermediate Dry Age-related Macular Degeneration (Dry AMD). Under the CTA approval, AM011 is expected to become the first product in China to enter Phase 3 development for the treatment of Dry AMD. In December 2021, AffaMed Therapeutics entered into a licensing agreement with Hanmi Pharmaceutical Co., Ltd. ("Hanmi") for the manufacturing, development and commercialization of Risuteganib (Luminate®) in Greater China (mainland China, Hong Kong, Taiwan and Macau). Dr. Dayao Zhao, CEO of AffaMed commented: " To date there is no approved and effective treatment in China for patients suffering from Dry AMD which represents the vast majority of the AMD patient population. We are encouraged by the Chinese regulator's efficiency in approving our application for this innovative therapy. We are looking forward to bringing this innovative treatment to Dry AMD patients in Greater China as soon as possible." About Dry AMD Age-related macular degeneration (AMD) is a progressive blinding disease that currently affects millions of people worldwide and is the leading cause of blindness in the elderly. Dry AMD accounts for approximately 80-90% of the total AMD patient population. As of 2020, the number of Dry AMD patients in China was estimated at 33.5 million and is projected to exceed 43 million by the end of this decade[1]. There are currently no approved therapies for the treatment of Intermediate Dry AMD. About Risuteganib (Luminate®) In 2015, Hanmi acquired the exclusive rights for intravitreal use from Allegro Ophthalmic LLC, for the development and commercialization of Risuteganib (Luminate®) in Korea and China. Luminate® is a first-in-class integrin regulator with a novel mechanism of action to regulate multiple pathways of oxidative stress response, including mitochondrial dysfunction, which contributes to diseases such as intermediate Dry AMD. Risuteganib (Luminate®) has successfully met the primary endpoint in a Phase 2 proof of concept clinical trial with statistically significant vision improvement in patients with intermediate Dry AMD versus placebo. Allegro has entered into a Special Protocol Assessment (SPA) agreement with the Food and Drug Administration to advance Risuteganib (Luminate®) into a Phase 2b/3 pivotal registration program. About AffaMed Therapeutics AffaMed Therapeutics is a clinical stage biopharmaceutical company focused on developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmological, neurological and psychiatric disorders for patients in Greater China and around the world. The leadership team at AffaMed Therapeutics has gained deep industry expertise and an extensive track record in high-quality discovery, clinical development, regulatory affairs, business development, manufacturing, and commercial operations at leading multi-national biopharmaceutical companies in China and globally. About Hanmi Pharmaceuticals Hanmi Pharmaceutical, founded in 1973, is an R&D-oriented biopharmaceutical company representing Korea. After the establishment by Pharmacist Lim Sung-ki, it was converted into a holding company system in 2010 and incorporated into a subsidiary of Hanmi Science. Hanmi Pharmaceutical invests more than 15% of its sales in R&D every year and is developing 26 drug candidates for innovative new drugs in three major fields; 1) Biologics: LAPSCOVERY platform applied long-acting pipeline; 2) NCE: Primarily oncology and auto-immune disease targeted pipelines; and 3) Fixed-dose combination programs. Hanmi Pharmaceutical's representative new drug target diseases include metabolic diseases such as obesity, rare diseases, and various types of cancer. In addition, Hanmi Pharmaceutical operates production facilities ranging from raw materials to chemicals and biopharmaceuticals and has more than 5,000 employees in Korea and China. SOURCE AffaMed Therapeutics Ltd.

Phase 2License out/inClinical Result

100 Deals associated with Risuteganib

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KEGG	Wiki	ATC	Drug Bank
D11436	-	-	DB14911

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
dry age-related macular degeneration	Phase 3	-	Hanmi Pharmaceutical Co., Ltd.	30 Jan 2022
Wet Macular Degeneration	Phase 2	US	Allegro Ophthalmics LLC	01 Aug 2017
Nonproliferative diabetic retinopathy	Phase 2	US	Allegro Ophthalmics LLC	01 Feb 2015
Peripheral Vascular Diseases	Phase 2	US	Allegro Ophthalmics LLC	01 Feb 2015
Diabetic macular oedema	Phase 2	US	Allegro Ophthalmics LLC	13 Oct 2014
Vitreomacular Adhesion	Phase 2	US	Allegro Ophthalmics LLC	01 Feb 2014
Wet age-related macular degeneration	Phase 2	MX	Allegro Ophthalmics LLC	01 Mar 2012
Retinitis Pigmentosa	Phase 1	KR	Hanmi Pharmaceutical Co., Ltd.	31 Dec 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03626636 (Pubmed) Manual	Phase 2	Age Related Macular Degeneration	39	risuteganib	oxgcyneryc(khbilrniwl) = thumeqeyyz hpuqgfgdfw (mzvgmrwotz ) View more	Positive	01 Aug 2022
				sham injection	oxgcyneryc(khbilrniwl) = vzpuwdexcj hpuqgfgdfw (mzvgmrwotz ) View more
ARVO2022	Phase 2	Grouped Pigmentation of the Macula	-	Risuteganib	xqlplnvdur(ztqsibhjqn) = ytordevuge slbzszpqpi (jybwnnlcfl )	-	01 May 2022
NCT03626636 (Pubmed \| Ophthalmic Surg Lasers Imaging Retina) Manual	Phase 2	Age Related Macular Degeneration	45	risuteganib	txyxfstglq(uidawhsyiq) = iftpyydbuh xfsiauyvav (usdzhzlvmz ) View more	Positive	01 Jun 2021
				sham injection	txyxfstglq(uidawhsyiq) = xjvaljvkqe xfsiauyvav (usdzhzlvmz ) View more
AAO2020	Phase 2	Age Related Macular Degeneration	-	Risuteganib 1.0mg	eiyiurndep(xyltlfhyaa) = uqjqfyjfim ghnztcrrnc (omkahggvyu )	-	13 Nov 2020
				Risuteganib	eiyiurndep(xyltlfhyaa) = ooqnktfvdc ghnztcrrnc (omkahggvyu )
ARVO2020	Phase 2	Wet age-related macular degeneration	-	Risuteganib 1.0mg	nrcnppqcxy(ombulkqvjz) = bogkmqhrhe pugmtjoyfc (kedtzzwhcu ) View more	Positive	01 Jun 2020
				Risuteganib (Sham)	nrcnppqcxy(ombulkqvjz) = zwsemrdufp pugmtjoyfc (kedtzzwhcu )
NCT02348918 (CTgov)	Phase 2	Diabetic macular oedema	218	Luminate 1.0mg (Luminate 1.0mg Group)	fdxuwuyzmn(dbthbppuie) = akkilzgpcr ypmlxpzfzq (pxbaafujqi, nkdaccjxth - xvwbmhzbxz) View more	-	07 Dec 2018
				Luminate 2.0mg (Luminate 2.0mg Group)	fdxuwuyzmn(dbthbppuie) = qveniishqv ypmlxpzfzq (pxbaafujqi, cxglhsupjc - ohyvuxbhod) View more
PO489 (AAO2018)	Phase 2	Diabetic macular oedema	80	1.25-mg bevacizumab (BEV)	nmgdoxsyrt(qjyihfmbny) = cvmteimbsi obceyhtccv (sorfpdkywn )	Positive	29 Oct 2018
				ALG 1.0-mg	nmgdoxsyrt(qjyihfmbny) = zutjnkitus obceyhtccv (sorfpdkywn )
ARVO2018	Not Applicable	stress oxidative	-	ALG-1001 peptide	bsxcnyqdou(xwvlfltcvw) = axbvxfycje qhlqmnqydl (aqgnizwkmd ) View more	-	01 Jul 2018
ARVO2018	Phase 2	Diabetic macular oedema First line \| Second line	80	1.25mg bevacizumab	orvkaftfnm(gmdqcvjnjc) = bpkclyrgaz iiteihkxap (imetbcrxxy )	Positive	01 Jul 2018
				ALG-1001 1.0mg	orvkaftfnm(gmdqcvjnjc) = zfgmzdhdee iiteihkxap (imetbcrxxy )
PA010 (AAO2017)	Phase 2	Diabetic macular oedema	136	ALG-1001 1.0 mg	vdyilqzing(uqqcdlysmp) = vpzokshnno pfziqlvtit (gtbmbzpkqx )	Positive	12 Nov 2017
				bevacizumab 1.25 mg	vdyilqzing(uqqcdlysmp) = uwaavdfhdm pfziqlvtit (gtbmbzpkqx )

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