RC28-E is a first-in-class VEGF/FGF dual-target fusion protein developed by RemeGen Co., Ltd. (“RemeGen”) for the treatment of eye diseases. On 20th July, 2024, a phase 1b clinical study of RC28-E for wet age-related macular degeneration (wAMD) was published on the international authoritative journal of ophthalmology, Ophthalmology and Therapy.

281.png

Ophthalmology and Therapy is an international authoritative journal in the ophthalmology field and publishes the latest research achievements, including ophthalmological therapies, clinical practice guidelines and innovative techniques, which has been indexed in SCI, SCIE and other international abstracting and indexing services.

The published study is a non-randomized, open-label and multicenter clinical study of multiple doses of RC28-E injection for wAMD through intravitreal injection. This study was led by Professor Hong Dai from Beijing Hospital and lasted for 48 weeks to evaluate the safety and preliminary efficacy of multiple doses of RC28-E.

According to the results, RC28-E (0.5 mg – 2.0 mg) showed favorable safety and tolerability in treating wAMD. Most of the adverse event (AE) during the study were mild to moderate and the most common AE was minor injection-related subconjunctival hemorrhage (16.2%). At Week 48, the best corrected visual acuity (BCVA) and central subfield thickness (CST) registered significant improvement after 1-year treatment in the RC28-E 0.5, 1.0 and 2.0 mg groups. In addition, 46% of the enrolled subjects in this study had polypoidal choroidal vasculopathy (PCV) and 73% of them have received other anti-VEGF treatment before enrollment. The results indicated that RC28-E were efficacious for these refractory patients.

Now, the phase 3 clinical study of RC28-E for wAMD and diabetic macular edema (DME) is proceeding and last patient out has been achieved in the phase 2 clinical study of RC28-E for diabetic retinopathy (DR). Dual-target RC28-E developed by RemeGen is expected to achieve breakthrough in the treatment of eye diseases, bringing treatment with more favorable efficacy and safety profile and better compliance for patients.

Source:

Lu Y, Yu X, Chen Y, et al. Safety and Efficacy of Multiple Escalating Doses of RC28-E for Neovascular Age-Related Macular Degeneration: A Phase 1b Trial. Ophthalmol Ther. Published online July 20, 2024. doi:10.1007/s40123-024-00994-z