What Cloudbreak Pharma does

Cloudbreak Pharma, Inc. is a clinical-stage ophthalmology biotechnology company founded in 2015 and headquartered in Irvine, California, with a regional office in Hong Kong and a listing on the Hong Kong Stock Exchange (HKEX: 2592). The company is developing a pipeline of first-in-class and best-in-class ophthalmic drugs targeting diseases with no FDA-approved pharmacological therapies, including pterygium, vascularized pinguecula, juvenile myopia, and presbyopia. As of mid-2025 it had four clinical-stage candidates — CBT-001 (nintedanib-based multi-kinase inhibitor eye drop for pterygium, Phase 3), CBT-004 (MKI eye drop for pinguecula, Phase 2 complete with Phase 3 readiness), CBT-009 (non-aqueous atropine for juvenile myopia, Phase 3), and CBT-199 (pupil-constricting formulation for presbyopia) — supported by four pre-clinical programs.

The company's scientific differentiation rests on two proprietary platforms: a Multi-Kinase Inhibitor (MKI) platform that simultaneously targets VEGFR, PDGFR, and FGFR to inhibit the angiogenesis and fibrosis driving pterygium and pinguecula; and a Semi-Fluorinated Alkanes (SFA+) drug-delivery platform providing non-aqueous, preservative-free formulations with improved stability and bioavailability for assets such as CBT-009 and CBT-199. The SFA+ carrier system directly addresses the long-standing stability limitation of aqueous low-dose atropine products.

Cloudbreak is pre-commercial and currently monetizes through regional licensing agreements rather than direct sales. In August 2024 it signed a licensing deal with Santen Pharmaceutical for CBT-001 across Japan and seven other Asia Pacific markets, worth up to US$91 million in upfront and milestone payments plus double-digit royalties on net sales. A 2020 agreement with Grand Pharmaceutical Group grants exclusive Greater China commercialization rights for CBT-001. The company is preparing for direct U.S. commercialization, evidenced by a new U.S. website launched in April 2026, appointment of Michael Rowe as Chief Business Officer in December 2025, and an experienced commercial leadership bench drawn from Allergan, Santen, Pfizer, Bayer, and Eyenovia.

Name

Cloudbreak Pharma

Legal name

Cloudbreak Pharma, Inc.

Website

https://cloudbreakpharma.com

Company type

Public

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Cloudbreak Pharma is a clinical-stage ophthalmology biotech developing first-in-class eye drops for pterygium, pinguecula, myopia, and presbyopia using proprietary multi-kinase inhibitor and SFA+ delivery platforms, monetizing via regional licensing with Santen and Grand Pharmaceutical pending FDA approval.

Ownership category

akta.pro rank

Product category

Ophthalmic Pharmaceuticals

NAICS

Pharmaceutical and Medicine Manufacturing (3254), Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Ophthalmology Pharmaceuticals (HLAIAAAL)

akta.pro secondary industries

Ophthalmology Specialty Pharmaceuticals (HLAIACAK), Ocular Drug Delivery Devices (Eye Droppers/Inserts) (HLAHAIAL)

Keywords

• Ophthalmic pharmaceuticals
• Biotechnology drug development
• Clinical-stage therapeutics
• Ophthalmic drug pipeline
• Eye disease treatments

Headquarters

HQ city

Irvine

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel

Revenue model

1. Licensing and Royalty Revenue: Pre-commercial biotech company generating revenue through licensing agreements. Received up to US$91 million in upfront and milestone payments from Santen Pharmaceutical for CBT-001 licensing in Japan and Southeast Asia. Also receives royalty payments as a percentage of future net sales.
2. Milestone Payments: Company receives milestone payments upon achievement of development and regulatory milestones from licensing partners such as Santen Pharmaceutical and Grand Pharmaceutical Group.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Cloudbreak Pharma is a clinical-stage biotechnology company developing first-in-class and best-in-class ophthalmic drug candidates for chronic eye diseases. Its pipeline includes CBT-001 (multi-kinase inhibitor eye drop for pterygium), CBT-004 (for vascularized pinguecula), CBT-009 (non-aqueous atropine for juvenile myopia), and CBT-199 (pupil-constricting formulation for presbyopia), enabled by proprietary MKI and SFA+ technology platforms. The company monetizes through regional licensing partnerships with pharmaceutical companies for commercialization.

Product overview

Cloudbreak Pharma is a clinical-stage ophthalmology biotechnology company developing a pipeline of novel first-in-class and best-in-class ophthalmic drugs. Its portfolio is anchored by two Phase 3-ready assets: CBT-001 (nintedanib-based multi-kinase inhibitor eye drop for pterygium) and CBT-004 (multi-kinase inhibitor eye drop for vascularised pinguecula), alongside CBT-009 (non-aqueous atropine formulation for juvenile myopia, Phase 3) and CBT-199 (pupil-constricting formulation for presbyopia, in development). The pipeline is enabled by two proprietary technology platforms: the MKI (Multi-Kinase Inhibitor) Platform targeting the root pathophysiology of fibrovascular eye diseases, and the SFA+ (Semi-Fluorinated Alkanes+) Platform providing a non-aqueous drug delivery carrier for improved stability and bioavailability.

Differentiator

Problem solved

Functional benefit

Products and services

• CBT-001 An emulsified nintedanib ophthalmic eye drop formulation (multi-kinase inhibitor) targeting VEGFRs, PDGFRs, and FGFRs for the treatment of pterygium. It inhibits neovascularization and tissue fibrosis, with the potential to become the first FDA-approved drug therapy for pterygium.
• CBT-004 A multi-kinase inhibitor eye drop targeting VEGFRs and PDGFRs for the treatment of vascularised pinguecula. It aims to reduce abnormal angiogenesis by blocking VEGF signaling and inhibit fibroblast activation via PDGFR suppression.
• CBT-009

Quantifiable outcome

• Pterygium vascularity reduction: -0.8 grade (p<0.001); 68% responder rate (≥1 grade improvement)
• +3 more outcomes

Segments4 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Three partnerships are on record, tiered core and minor.

• Santen Pharmaceutical Co., Ltd. (参天制药)coreOEM/ Whitelabel/ Licensing Partner · 6 August 2024Licensing agreement for CBT-001 (nintedanib eye drops for pterygium treatment). Santen receives rights to develop, manufacture and commercialize CBT-001 in Japan, South Korea, Vietnam, Thailand, Malaysia, Philippines, Singapore, and Indonesia. Cloudbreak receives up to US$91 million in upfront and milestone payments plus double-digit royalties on net sales. Santen is a specialist ophthalmology company with 140+ years of history serving approximately 50 million people in 60+ countries.
• Centre for Eye and Vision Research Ltd. (CEVR)minorStrategic or Co-development Partner · 17 May 2023Strategic cooperation memorandum of understanding signed at Asia Healthcare Summit in Hong Kong. CEVR is established under Hong Kong's InnoHK initiative as a collaboration between Hong Kong Polytechnic University and University of Waterloo, Canada. The partnership aims to pursue further research in ophthalmic science development, aligned with Cloudbreak's CBT-006 clinical pipeline research direction.
• Grand Pharmaceutical Group Limited (远大医药)coreOEM/ Whitelabel/ Licensing Partner · 1 April 2020Commercialization license agreement granting Grand Pharmaceutical Group (00512.HK) exclusive, sublicensable rights with royalty for production and commercialization of CBT-001 in Mainland China, Hong Kong SAR, Macau SAR, and Taiwan region. The license covers the investigational indications of prevention of pterygium growth and reduction of conjunctival congestion.

Scale indicators8 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• AbbVie (Allergan Aesthetics / Eye Care): Inheritor of Allergan's ophthalmology franchise (RESTASIS, LUMIGAN, BOTOX). Broad incumbent comparable because Allergan's former leadership now sits in Cloudbreak's C-suite, and Allergan historically dominated the anterior-segment ophthalmic prescription market Cloudbreak is targeting.
• Alcon: World's largest dedicated ophthalmology company spanning surgical, vision care, and pharmaceuticals. Broad incumbent with portfolio capabilities that overlap Cloudbreak's surface eye-disease therapeutic focus, providing a benchmark for end-stage commercial scale.
• Bausch + Lomb (Bausch Health): Major diversified ophthalmology company across pharmaceuticals, surgical devices, and contact lenses. Broad incumbent with overlapping therapeutic focus on chronic anterior-segment conditions and an established global commercialization footprint.
• Santen Pharmaceutical: Japan-headquartered global specialist ophthalmology company and Cloudbreak's licensing partner for CBT-001 across APAC. Direct incumbent comparator: established commercial infrastructure, broad ophthalmic portfolio, and Asia-Pacific regulatory reach that materially exceeds Cloudbreak's.

Direct peers

• Eyenovia: Clinical-stage ophthalmology biotech focused on micro-dose array print (MAP) drug delivery. Closely comparable in stage, size, and therapeutic focus; Cloudbreak's newly hired CBO Michael Rowe was previously CEO of Eyenovia, evidencing deep familiarity with the comparable's strategy and challenges.
• Aldeyra Therapeutics: Clinical-stage biotech developing novel small-molecule therapies for ocular and systemic inflammatory diseases. Comparable as a small-cap, pre-commercial, platform-based ophthalmology developer with multiple Phase 2/3 assets in chronic eye conditions.
• Ocuphire Pharma: Clinical-stage ophthalmology biotech focused on small-molecule therapies for refractive and retinal indications. Comparable size and stage, with similar reliance on licensing or strategic transactions to advance pipeline assets in underserved ocular indications.
• EyePoint Pharmaceuticals: Clinical and early-commercial ophthalmology biotech developing sustained-release ocular drug delivery using bioerodible Durasert and Yutiq platforms. Directly comparable in targeting chronic anterior- and posterior-segment eye diseases with proprietary delivery platforms.
• Ocular Therapeutix: Clinical/commercial ophthalmology company developing sustained-release drug formulations (intracameral implants, topical hydrogels). Highly comparable business model of proprietary drug-delivery platforms (akin to Cloudbreak's SFA+) applied to ophthalmic indications with high unmet need.

Emerging players

• Adverum Biotechnologies: Clinical-stage gene therapy company targeting ophthalmic diseases (wet AMD, diabetic macular edema). Adjacent emerging player rather than direct competitor (different modality), but comparable in size, stage, and the strategy of pursuing high-unmet-need ocular indications with novel platforms.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Cloudbreak Pharma