transferrin-tumstatin (OCU200) / Ocugen - LARVOL DELTA

Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME) (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Ocugen | Trial completion date: Oct 2025 ➔ Jul 2026 | Trial primary completion date: Sep 2025 ➔ Jul 2026

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

Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME) (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Ocugen | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2023 ➔ Oct 2025 | Trial primary completion date: Sep 2023 ➔ Sep 2025

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

Data and Safety Monitoring Board Reviews Cohort 1 Safety Data and Approves Dosing Cohort 2 in the Clinical Trial of OCU200—a Novel Fusion Protein for Diabetic Macular Edema (GlobeNewswire) - "Ocugen, Inc...announced that the Data and Safety Monitoring Board (DSMB) for the OCU200 clinical trial recently convened and reviewed safety data following dosing of the first cohort in the dose-escalation portion of the Phase 1 study and approved continuation of dosing in the second cohort...'No serious adverse events related to OCU200 have been reported to date'....The Company intends to complete the Phase 1 OCU200 clinical trial in the second half of 2025 and to provide preliminary safety and efficacy updates throughout the year."

DSMB • P1 data • Trial status • Diabetic Macular Edema

Ocugen, Inc. Announces First Patient Dosed in Phase 1 Clinical Trial of OCU200-a Novel Integrin-Targeting Biologic for Diabetic Macular Edema (GlobeNewswire) - "Ocugen...announced that the first patient has been dosed in the OCU200 Phase 1 clinical trial for diabetic macular edema (DME)....The OCU200 Phase 1 clinical trial is a multicenter, open-label, dose-escalation study to assess drug safety via intravitreal injection in three cohorts: low dose (0.025 mg), medium dose (0.05 mg), and high dose (0.1 mg). All subjects will receive a total of two intravitreal injections of OCU200 six weeks apart. Patient follow-up will take place up to three months after the last injection."

Trial status • Diabetic Macular Edema

"@Ocugen @OcugenPE is ready to go on command! #OCU500 #OCU400 #OCU200 💪🏼 @US_FDA @BARDA" (@nrbarile)

Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME) (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: Ocugen

New P1 trial • Diabetic Macular Edema • Ophthalmology

Ocugen, Inc. Announces Submission of Investigational New Drug Application with U.S. FDA to Initiate a Phase 1 Clinical Trial Evaluating OCU200 for the Treatment of Diabetic Macular Edema (GlobeNewswire) - "Ocugen...announced that it has submitted an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial of OCU200, a fusion protein with a distinct mechanism of action (MOA), for the treatment of diabetic macular edema (DME)....The planned Phase 1 clinical study will assess the unilateral intravitreal administration of OCU200 alone or in combination with an approved anti-VEGF therapy in participants with DME. This is a multicenter, open-label, dose-ranging study with 3 cohorts in the dose-escalation portion of the study and 1 cohort in the combination therapy portion of the study....The Company intends to pursue additional indications for OCU200 to potentially treat diabetic retinopathy and wet age-related macular degeneration, which combined affect nearly 9.0 million Americans."

IND • New indication • New P1 trial • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Macular Edema • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Binding affinity: A measure of potency for OCU200, a potential therapeutic for the treatment of wet-AMD and DME (ARVO 2022) - "OCU200 binds to the transferrin receptor in a dose dependent manner, supporting our hypothesis that transferrin targets OCU200 to the choroid and retina mediated through the transferrin receptor. Binding affinity with receptor can be used a measure of potency for OCU200."

Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • Tumstatin

[VIRTUAL] OCU200 (transferrin-tumstatin fusion protein): A potential therapeutic for DME, DR, and wet-AMD (ARVO 2021) - "OCU200 acts on endothelial cells specifically to decrease cell proliferation, cell invasion, and tube formation. In addition, the in vivo results suggest that OCU200 is efficient in reducing neovascularization and damage to retina in mouse OIR model and has comparable/slightly improved activity to aflibercept. These findings demonstrate OCU200 as a potential therapeutic for the treatment of DME, DR, and wet-AMD."

Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • Tumstatin