sunitinib maleate (GB-102) / CalciMedica - LARVOL DELTA

Treatment of Retinal/Choroidal Vascular Diseases by Sustained Delivery of VEGF Receptor Tyrosine Kinase Inhibitors. (PubMed, Am J Ophthalmol) - "Sustained delivery of VEGF receptor TKIs represents a promising therapeutic paradigm for retinal and choroidal vascular diseases, potentially reducing treatment burden while maintaining efficacy. Continued evaluation through larger, controlled clinical trials is essential to validate these early findings and define the role of these agents in clinical practice."

Clinical • Journal • Age-related Macular Degeneration • Cardiovascular • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Advances in Wet AMD Research (Retina Today) - "Although intravitreal anti-VEGF injections are an effective therapy for wet AMD, the associated treatment burden is significant, pushing researchers to search for novel approaches. Numerous therapeutics and drug delivery systems are in the research pipeline, offering hope for a reduced treatment burden and improved outcomes in the future."

Online posting

Intravitreal Sunitinib Malate Depot (GB-102): Durability and Safety in Wet Age-Related Macular Degeneration (ALTISSIMO, Phase 2B) (AAO 2021) - No abstract available

Clinical • Late-breaking abstract • P2b data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Safety and Durability of Intravitreal Sunitinib Malate Depot (GB-102) in Wet AMD (ALTISSIMO, Phase 2b Trial) (AAO 2021) - "Majority of drug-related adverse events were mild to moderate, and none led to drug discontinuation. Mean change in BCVA was lower in the GB-102 arm than the aflibercept arm, but CST was comparable in both arms."

Clinical • P2b data • Ophthalmology • Wet Age-related Macular Degeneration

Current Clinical Trials in Diabetic Macular Edema: Various therapies are in development (Retin Physician) - "Diabetic macular edema (DME) represents a leading causes of irreversible legal blindness in the industrialized world. Therapeutically, corticosteroids were utilized early in the treatment of DME. Intravitreal (IVT) corticosteroids, which reduce inflammatory cytokines and act on several pathogenic pathways in DME, have proven effective for the management of DME, supplementing focal laser."

Online posting

ALTISSIMO: A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD (clinicaltrials.gov) - P2b; N=56; Completed; Sponsor: Graybug Vision; Active, not recruiting ➔ Completed

Clinical • Trial completion • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Vascular Endothelial Growth Factor Antagonists: Promising Players in the Treatment of Neovascular Age-Related Macular Degeneration. (PubMed, Drug Des Devel Ther) - "Abicipar pegol, a designed ankyrin repeat protein (DARPin), demonstrated the ability to maintain stable visual acuity with 12-week dosing, but was not approved by the FDA due to higher than usual rates of intraocular inflammation. Conbercept, a recombinant anti-VEGF fusion protein, has been approved in China, and is in Phase 3 trials globally. KSI-301 is an anti-VEGF antibody biopolymer conjugate that allowed 66% of nAMD patients to maintain at least a 6-month treatment-free interval in Phase 1b studies. OPT-302, an inhibitor of VEGF-C/D, will be tested in phase 3 studies that compare anti-VEGF-A monotherapy against combination therapy with OPT-302. Faricimab is a bispecific anti-VEGF/Ang-2 antibody that upregulates the Tie-2 signaling pathway and promotes vascular stability; it is undergoing phase 3 trials with potential for 12- or 16-week dosing. PAN-90806 is a topical anti-VEGF agent that showed the ability to reduce injection frequency by 79% compared to ranibizumab..."

Journal • Review • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Gene Therapies • Immunology • Inflammation • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • VEGFC

ALTISSIMO: A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD (clinicaltrials.gov) - P2b; N=56; Active, not recruiting; Sponsor: Graybug Vision; Trial completion date: Feb 2021 ➔ Jun 2021

Clinical • Trial completion date • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Diabetic Macular Edema and Retinal Vein Occlusion (clinicaltrials.gov) - P2a; N=21; Completed; Sponsor: Graybug Vision; Active, not recruiting ➔ Completed

Clinical • Trial completion • Diabetic Macular Edema • Ophthalmology • Retinal Vein Occlusion

Emerging Therapies in Neovascular Age-Related Macular Degeneration in 2020. (PubMed, Asia Pac J Ophthalmol (Phila)) - "For nAMD: Abicipar pegol, an intravitreal anti-vascular endothelial growth factor based on designed ankyrin repeat proteins (DARP) in protein, is currently pending approval. Conbercept and Faricimab, 2 intravitreal anti-growth factors, are currently in phase 3. Nine other upcoming agents have at least produced results in the 2A phase including intravitreal injections (KSI-301, OPT-302, RGX-314, ICON-1, and DE-122), depot (GB-102), drug reservoir (PDS), topical drops (PAN-90806), and oral formulations (AKST4290). We summarize all the newer molecules."

Journal • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Gene Therapies • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Hansen Pharmaceutical’s anticancer drug sunitinib malate approved for listing [Google Translation] (Beijing News) - "Hansen Pharmaceuticals announced that four types of generic drugs, sunitinib malate capsules, were approved for listing...Sunitinib malate is an anti-tumor drug, suitable for the treatment of inoperable advanced renal cell carcinoma; gastrointestinal stromal tumors where imatinib mesylate failed or could not be tolerated; unresectable and metastatic advanced differentiation Pancreatic neuroendocrine tumors."

ANDA • Genito-urinary Cancer • Oncology • Sarcoma • Solid Tumor • Urothelial Cancer

REGENXBIO announces additional positive long-term and interim Phase I/IIA trial update for RGX-314 for the treatment of wet AMD (Regenxbio) - "April 22, 8:30 a.m, Featuring wet AMD Key Opinion Leaders."

Live event • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Graybug Vision initiates phase 2b (ALTISSIMO) clinical trial of GB-102 in patients with wet age-related macular degeneration (Businesswire) - "Graybug Vision, Inc., a clinical stage pharmaceutical company developing potentially transformative long-acting therapies for ocular diseases, including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), retinal vein occlusion (RVO), and primary open angle glaucoma (POAG), today announced the initiation of its Phase 2b study (ALTISSIMO) with GB-102 in patients with wet AMD....ALTISSIMO is a 12-month, 3-arm, randomized controlled study evaluating two dose levels of GB-102 (1 mg and 2 mg) administered every six months compared to aflibercept (2 mg) administered every two months in patients with wet AMD."

Enrollment open