OTT166 / OcuTerra Therap - LARVOL DELTA

RNA-seq suggests integrins as a potential therapeutic target in epiretinal membrane pathogenesis (ARVO 2024) - "The identification of upregulation of integrins α-1, α-3, α-11 and β-4 in epiretinal membranes is a new and exciting finding. Integrins have a critical role in linking the cell and extracellular matrix and play a role in cell migration and transition from quiescent to proliferative states. Anti-integrin therapies, including risuteganib, THR-687 and SF-0166 are being investigated for use in retinovascular diseases including diabetic macular oedema and age-related macular degeneration, but this study suggests that epiretinal membrane is another possible indication for these therapies."

Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Macular Edema • Ophthalmology • Retinal Disorders

Nesvategrast (OTT166) in Diabetic Retinopathy (DR) (clinicaltrials.gov) - P2 | N=225 | Completed | Sponsor: OcuTerra Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

OTT166 in Diabetic Retinopathy (DR) (clinicaltrials.gov) - P2 | N=225 | Active, not recruiting | Sponsor: OcuTerra Therapeutics, Inc. | Trial completion date: May 2024 ➔ Jan 2024 | Trial primary completion date: May 2024 ➔ Jan 2024

Trial completion date • Trial primary completion date • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

OTT166 in Diabetic Retinopathy (DR) (clinicaltrials.gov) - P2 | N=210 | Active, not recruiting | Sponsor: OcuTerra Therapeutics, Inc. | Trial completion date: Jan 2024 ➔ May 2024 | Trial primary completion date: Jan 2024 ➔ May 2024

Trial completion date • Trial primary completion date • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

OTT166 in Diabetic Retinopathy (DR) (clinicaltrials.gov) - P2 | N=210 | Active, not recruiting | Sponsor: OcuTerra Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

OTT166 in Diabetic Retinopathy (DR) (clinicaltrials.gov) - P2 | N=210 | Recruiting | Sponsor: OcuTerra Therapeutics, Inc. | Trial completion date: Dec 2023 ➔ Mar 2024 | Trial primary completion date: Dec 2023 ➔ Mar 2024

Trial completion date • Trial primary completion date • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

The Safety and Biological Activity of OTT166, a Novel Topical Selective Integrin Inhibitor for the Treatment of Diabetic Eye Disease: A Phase 1b Study. (PubMed, Ophthalmic Surg Lasers Imaging Retina) - "OTT166 eyedrops were safe, well-tolerated, and demonstrated biological activity in 37% of responders. These results warrant further evaluation of OTT166 eyedrops. [Ophthalmic Surg Lasers Imaging Retina 2022;53:553-560.]."

Journal • P1 data • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

OTT166 in Diabetic Retinopathy (DR) (clinicaltrials.gov) - P2 | N=210 | Recruiting | Sponsor: OcuTerra Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

OTT166 in Diabetic Retinopathy (DR) (clinicaltrials.gov) - P2 | N=210 | Not yet recruiting | Sponsor: OcuTerra Therapeutics, Inc. | Trial completion date: May 2023 ➔ Dec 2023 | Trial primary completion date: May 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

OTT166 in Diabetic Retinopathy (DR) (clinicaltrials.gov) - P2 | N=210 | Not yet recruiting | Sponsor: OcuTerra Therapeutics, Inc.

New P2 trial • Diabetic Retinopathy • Ophthalmology • Retinal Disorders

Anti-Integrin therapy for retinovascular diseases. (PubMed, Expert Opin Investig Drugs) - "Clinical candidates include risuteganib, THR-687, SF-0166, which have shown promise in treating diabetic macular edema (DME) and non-neovascular AMD in early clinical studies. Preclinical candidates include SB-267268, JNJ-26076713, Cilengitide and Lebecetin, which exhibit a decrease in retinal permeability, angiogenesis and/or choroidal neovascularization (CNV)...Anti-integrin agents tackle the multi-factorial nature of DR and AMD and show promise as injectable and topical agents in preclinical and early clinical studies. Integrin inhibition has potential to serve as primary therapy, adjunctive therapy to anti-vascular endothelial growth factor agents, or secondary therapy in refractory cases."

Journal • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Diabetic Macular Edema • Diabetic Retinopathy • Fibrosis • Gene Therapies • Immunology • Ophthalmology • Retinal Disorders

Pharmacodynamics and Pharmacokinetics of SF0166, a Topically Administered αvβ3 Integrin Antagonist, for the Treatment of Retinal Diseases. (PubMed, J Pharmacol Exp Ther) - P1/2; "In the vascular endothelial growth factor-induced early neovascularization and vascular leakage model, topical ocular application of SF0166 resulted in a dose-dependent reduction in vascular leakage; the highest ocular doses tested showed comparable activity to a bevacizumab injection. In summary, SF0166 was safe and efficacious in animal models of ocular neovascularization and Phase I/II clinical trials in patients with diabetic macular edema (NCT02914613) and neovascular age-related macular degeneration (NCT02914639) have recently completed."

Journal • PK/PD data