CG-P5 peptide / Caregen - LARVOL DELTA

Caregen's macular degeneration eye drop demonstrates safety and efficacy in phase 1 clinical trials. [Google translation] (HIT News) - "Clinical results showed that CG-P5 exhibited excellent safety and tolerability without any significant adverse reactions. No unusual findings were observed in intraocular pressure, inflammatory response, blood, or biochemical tests...While the CG-P5 group maintained visual acuity at 12 weeks, the placebo group lost an average of 8.4 letters, resulting in a difference of approximately 8.6 letters between the two groups....Based on these clinical data, Caregen plans to submit an Investigational New Drug (IND) application for CG-P5 to the US FDA in the first quarter of 2026. In this phase 2 trial, the indications will be expanded to include dry macular degeneration and treatment-naïve patients."

IND • New P2 trial • P1 data • Macular Degeneration • Wet Age-related Macular Degeneration

Caregen Unveils CG-P5, a Treatment for Wet Macular Degeneration, at APAO2025 [Google translation] (HIT News) - "Caregen, a biotechnology company...announced that it will unveil its wet macular degeneration treatment drug 'CG-P5' at the Asia Pacific Academy of Ophthalmology (APAO) 2025, held in New Delhi, India from the 3rd to the 6th...At APAO 2025, Caregen aims to introduce the mechanism of action and clinical progress of CG-P5 and strengthen its technological leadership and position in the global ophthalmic market....Currently, CG-P5 is in the final stages of the US Food and Drug Administration (FDA) Phase 1 clinical trial, and a comparative clinical trial using Ilia as a control group is in progress. The clinical trial is scheduled to end around June, and an application for Breakthrough Therapy Designation (BTD) is being prepared."

Clinical • Trial completion date • Age-related Macular Degeneration • Wet Age-related Macular Degeneration

Study to Evaluate the Safety of CG-P5 Peptide Eye Drops in Patients Diagnosed With Age-related Wet Macular Degeneration (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Caregen Co. Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Nov 2024 ➔ Aug 2025 | Trial primary completion date: Oct 2024 ➔ May 2025

Enrollment open • Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Study to Evaluate the Safety of CG-P5 Peptide Eye Drops in Patients Diagnosed With Age-related Wet Macular Degeneration (clinicaltrials.gov) - P1 | N=45 | Not yet recruiting | Sponsor: Caregen Co. Ltd.

Trial completion date • Trial initiation date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration