Technology

Innovative drug therapies to treat ophthalmic diseases

Cloudbreak Pharma has formulated a potent multi-kinase inhibitor to block angiogenesis (development of new blood vessels) and fibrosis (formation of excess fibrous connective tissue) into a topical eye drop to treat anterior segment ophthalmic diseases.

MULTIKINASE INHIBITOR (MKI)

Our lead technology, Multi-Kinase Inhibitor (MKI), is de-risked with human clinical results and uniquely suitable for both front-of-eye and back-of-eye diseases. We formulated a potent multi-kinase inhibitor which can block VEGFR (1-3), PDGFR (,), FGFR (1-3) into a topical eye drop to treat pterygium, pinguecula, glaucoma filtration surgery, and adjunct therapy for cornea transplant surgery following 505b(2) regulatory pathway.

First to Enter a Potential $1 Billion Opportunity

There are currently no approved drug therapies that address hyperemia and the pterygium lesion

May delay or eliminate need for surgery

Pharmacologically targeting the angiogenic and fibrovascular pathogenesis of pterygium with promising clinical trial results

Desirable safety profile versus off-label options

In clinical studies, no systemic effects and ocular AEs were mild and transient; may be used safely well beyond duration limits for corticosteroids

SFA+ PLATFORM

Cloudbreak’s proprietary SFA+ platform is a semi‑fluorinated alkane–based, non‑aqueous delivery system with novel moieties that enables comfortable, multi‑dose, preservative‑free eye drops with long shelf life, providing a stable formulation option for otherwise “unstable” drugs and creating multiple new ophthalmic product opportunities through improved safety, comfort, and innovative life‑cycle management.

First to Enter a Potential $1 Billion Opportunity

There are currently no approved drug therapies that address the basis of the pinguecula lesion

Only option that is disease-modifying

Surgery is not typically an option; CBT-004 has demonstrated sustained effect after dosing is stopped unlike off-label corticosteroids

Desirable safety profile versus off-label options

In clinical studies, no systemic effects and ocular AEs were mild and transient; no treatment-limiting side effects (unlike corticosteroids)