RC28-E / Rongchang Pharma - LARVOL DELTA

Effectively improve patients' vision! RC28-E Phase II clinical trial results for diabetic macular edema (DME) announced | ARVO 2025 [Google translation] (RemeGen Press Release) - P2 | N=156 | NCT04782115 | Sponsor: RemeGen Co., Ltd. | "The results showed that RC28-E can effectively improve the best corrected visual acuity (BCVA) of DME patients, reduce the central retinal thickness (CST) of the macula, and effectively relieve macular edema...At week 52, the BCVA of the control group, 1.0 mg Q8W group, 1.0 mg PRN group, 2.0 mg Q8W group, and 2.0 mg PRN group increased by 8.4 letters, 5.5 letters, 9.5 letters, 9.2 letters, and 9.7 letters, respectively, compared with the baseline....the Phase III clinical trial of RC28-E for the treatment of DME has completed patient follow-up, and it is expected to submit a domestic marketing application in the second half of 2025; in addition, the Phase III clinical study for the treatment of wet age-related macular degeneration (wAMD) is underway, and it is expected to submit a domestic marketing application in the first half of 2026."

China filing • P2 data • Trial status • Diabetic Macular Edema • Wet Age-related Macular Degeneration

Simultaneous Inhibition of Fibroblast Growth Factor-2 and Vascular Endothelial Growth Factor-A with RC28-E in Diabetic Macular Edema: A Phase 2 Randomized Trial (ARVO 2025) - P2 | "Purpose To compare different doses and dosing regimens of RC28-E, a novel bispecific antibody that simultaneously binds vascular endothelial growth factor-A (VEGF-A) and fibroblast growth factor-2 (FGF-2), with conbercept in patients with diabetic macular edema (DME) Methods Design: Prospective, randomized, active comparator-controlled, open-label, multicenter, phase 2 clinical trial. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • P2 data • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Retinal Disorders • FGF2

Simultaneous inhibition of fibroblast growth factor-2 and vascular endothelial growth factor-a with RC28-E in diabetic macular edema: a phase 2 randomised trial. (PubMed, Br J Ophthalmol) - P2 | "Intravitreous RC28-E improved BCVA and CST in eyes with centre-involved DME. Compared with conbercept, the 2.0mgPRN regimen of RC28-E was recommended due to its superior efficacy in improving vision particularly for patients with poor glycaemic control, fewer treatment injections during the maintenance phase and comparable safety profile."

Journal • P2 data • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Retinal Disorders • FGF2

Simultaneous Inhibition of Fibroblast Growth Factor-2 and VEGF-A With RC28-E in DME: A Phase 2 Randomized Trial (AAO 2024) - "Incidence of ocular and non-ocular adverse events was comparable between RC28-E groups and the conbercept group. Conclusion RC28-E demonstrated efficacy and tolerability comparable with those of conbercept in DME."

Clinical • P2 data • Diabetic Macular Edema • Ophthalmology • FGF2

Safety and Efficacy of Multiple Escalating Doses of RC28-E for Neovascular Age-Related Macular Degeneration: A Phase 1b Trial. (PubMed, Ophthalmol Ther) - "RC28-E was well tolerated and exhibited an overall favorable safety profile with evidence of improvements in BCVA and anatomical parameters."

Journal • P1 data • Age-related Macular Degeneration • Hematological Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • FGF

Evaluation of RC28-E Injection in Diabetic Retinopathy (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: RemeGen Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2023 ➔ Jul 2024 | Trial primary completion date: Oct 2023 ➔ May 2024

Enrollment closed • Trial completion date • Trial primary completion date • Diabetic Retinopathy • Retinal Disorders

Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema (clinicaltrials.gov) - P3 | N=316 | Recruiting | Sponsor: RemeGen Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Macular Edema • Ophthalmology

Evaluation of RC28-E Injection in Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=156 | Completed | Sponsor: RemeGen Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Jul 2023 | Trial primary completion date: Nov 2023 ➔ Jul 2023

Trial completion • Trial completion date • Trial primary completion date • Diabetic Macular Edema • Ophthalmology

Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema (clinicaltrials.gov) - P3 | N=316 | Not yet recruiting | Sponsor: RemeGen Co., Ltd.

New P3 trial • Diabetic Macular Edema • Ophthalmology

Efficacy and Safety of RC28-E Versus Aflibercept (clinicaltrials.gov) - P3 | N=432 | Recruiting | Sponsor: RemeGen Co., Ltd.

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Evaluation of RC28-E Injection in Wet Age-related Macular Degeneration (clinicaltrials.gov) - P1/2; N=37; Completed; Sponsor: RemeGen Co., Ltd.; Active, not recruiting ➔ Completed

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

Evaluation the Pharmacokinetics,Safety,Tolerability of Single Intravitreal Injection RC28-E in Subjects With Wet Age-Related Macular Degeneration (clinicaltrials.gov) - P1; N=12; Completed; Sponsor: RemeGen; Recruiting ➔ Completed

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

Evaluation of RC28-E Injection in Wet Age-related Macular Degeneration (clinicaltrials.gov) - P1/2; N=37; Active, not recruiting; Sponsor: RemeGen; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Evaluation of RC28-E Injection in Wet Age-related Macular Degeneration (clinicaltrials.gov) - P1/2; N=36; Recruiting; Sponsor: RemeGen; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Oct 2020 ➔ Oct 2021

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

Evaluation of RC28-E Injection in Diabetic Retinopathy (clinicaltrials.gov) - P2; N=120; Recruiting; Sponsor: RemeGen; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Diabetic Retinopathy • Retinal Disorders

Evaluation of RC28-E Injection in Diabetic Macular Edema (clinicaltrials.gov) - P2; N=150; Recruiting; Sponsor: RemeGen; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Diabetic Macular Edema • Ophthalmology

Evaluation of RC28-E Injection in Diabetic Macular Edema (clinicaltrials.gov) - P2; N=150; Not yet recruiting; Sponsor: RemeGen

Clinical • New P2 trial • Diabetic Macular Edema • Ophthalmology

Evaluation of RC28-E Injection in Diabetic Retinopathy (clinicaltrials.gov) - P2; N=120; Not yet recruiting; Sponsor: RemeGen

Clinical • New P2 trial • Diabetic Retinopathy • Retinal Disorders

Pharmacology Study of the Multiple Angiogenesis Inhibitor RC28-E on Anti-Fibrosis in a Chemically Induced Lung Injury Model. (PubMed, Biomolecules) - P1 | "A bleomycin-induced pulmonary fibrosis C57BL/6 mouse model was established. RC28-E exhibits significant anti-fibrosis effects on Idiopathic pulmonary fibrosis (IPF) in vivo. Moreover, TGF-β induced fibroblast activation in vitro via the inhibition of the TGF-β downstream Smad pathway, thus providing potential therapeutics for clinical disease-related fibrosis-like IPF as well as chemotherapy-induced fibrosis in cancer therapy."

Journal • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Oncology • Respiratory Diseases

In vivo characterization of RC28-E, a fusion protein targeting VEGF and bFGF: Pharmacokinetics and ocular distribution in primates. (PubMed, Exp Eye Res) - "No drug accumulation after multiple administration was noticed, but low titers of antibody produce against RC28-E were detected. Overall, RC28-E exhibited high clinical value due to adequate pharmacokinetic profiling, safety and efficacy."

Journal • PK/PD data • Preclinical • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

Evaluation the Pharmacokinetics,Safety,Tolerability of Single Intravitreal Injection RC28-E in Subjects With Wet Age-Related Macular Degeneration (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: RemeGen; Trial completion date: Dec 2019 ➔ Jun 2020; Trial primary completion date: Dec 2019 ➔ May 2020

Clinical • Trial completion date • Trial primary completion date

Evaluation of RC28-E Injection in Wet Age-related Macular Degeneration (clinicaltrials.gov) - P1/2; N=36; Recruiting; Sponsor: RemeGen

Clinical • New P1/2 trial