首個針對瞼裂斑根源的藥物療法
拨康视云 批准的瞼裂斑藥物療法——該病症在全球範圍內影響超過 10 億人，且目前尚無獲批的藥理學選擇。我們的核心項目 CBT-004是一款專利 多激酶抑制劑 (MKI) 滴眼液，旨在同時針對驅動瞼裂斑異常纖維血管變化的多種信號通路，而非僅僅針對症狀。
多激酶抑制劑
針對整個疾病級聯反應，而非單一通路
目前瞼裂斑的處理旨在緩解症狀和控制眼表炎症，而非消除潛在的退行性病變。人工淚液潤滑、抗炎藥物和環境改善可以減輕刺激，但緩解通常不完全且短暫，且可見的病變通常仍然存在。在更困擾的情況下，患者可能仍受紅腫、不適或隱形眼鏡不耐受的困擾，僅有極少數人因持續性炎症或美容顧慮而接受手術，這突顯了對更優質、針對性療法的需求。
瞼裂斑是如何產生的
長期紫外線照射會引發結膜組織的一系列細胞損傷：
紫外線暴露： 結膜細胞和角膜緣成纖維細胞的 DNA 損傷
細胞活化： 炎性細胞因子（TNF-α、IL-6、IL-8）水平上升
生長因子釋放： VEGF、PDGF、FGF、TGF-β 的過表達
血管形成與纖維化： 異常纖維血管沉積物的形成
CBT-004 如何干預
由於瞼裂斑涉及多個重疊的信號通路， 單一靶向療法是不夠的。 當一個通路被阻斷時，其他通路會進行補償，從而導致疾病持續或進展。 Cloudbreak的 MKI 平台 通過 同時進行多通路抑制來防止這種情況。
CBT-004 的作用靶點：
VEGFRs：抑制病理性血管生成/血管形成
PDGFRs：減少成纖維細胞活化和結締組織重塑
FGFRs：抑制進一步的炎性細胞信號傳導
CBT-004：臨床概念驗證
CBT-004：臨床概念驗證
首個瞼裂斑疾病修飾的藥理學證明。
| 治療組 | 結膜充血分級變化 | 對照组（安慰劑）的 p 值 | |
|---|---|---|---|
| 對照組 | 0.30 | --- | N/A |
| CBT-004 0.05% | -0.68 | p = 0.043 | 具有統計學意義 |
| CBT-004 0.075% | -0.78 | p = 0.012 | 具有統計學意義 |
關鍵臨床亮點
DOSE RESPONSE
Clear relationship observed between dose and efficacy (0.075% > 0.05% > vehicle) for hyperemia grade change
EARLY ONSET
High dose showed a significant effect as early as Day 7
(p = 0.007)
CLEAR EFFICACY
Both doses superior to vehicle and are superior to current SOC options
WELL TOLERATED
No systemic effects; mild & transient local AEs only
The time course data illustrates that CBT-004’s effects emerge rapidly and are sustained through the primary endpoint. The 0.075% high-dose arm demonstrated a statistically significant separation from vehicle as early as Day 7 (p = 0.007) — a clinical indicator of rapid onset of pharmacological activity. Both doses continued to show significant benefit at Day 28, the primary endpoint. This early and sustained efficacy profile supports CBT-004’s potential as the first meaningful pharmacological therapy for vascularized pinguecula.
正在開發首個有望獲得 FDA 批准的瞼裂斑藥物療法——該病症在全球範圍內影響超過 10 億人，且目前尚無獲批的藥理學選擇。
Primary Complaint from People with Pinguecula
Why Measuring Both Hyperemia and Foreign Body Sensation (FBS) Matters Clinically:
A treatment that reduces observable vascular pathology (hyperemia) without improving how patients feel (FBS and related symptoms) would offer limited real-world therapeutic value. Conversely, a treatment that only masks symptoms without addressing underlying disease mechanisms would not represent true disease modification.
CBT-004’s dual impact — on both objective vascular signs and subjective symptom burden — validates its potential as a comprehensive, disease-modifying therapy that addresses the full spectrum of pinguecula pathology.
CBT-004 Phase 2 Results: Foreign Body Sensation (VAS Score, 0-100 Scale)
What Was Measured: Foreign body sensation was assessed using a Visual Analog Scale (VAS) where patients rated their current level of grittiness/discomfort on a 0-100 scale (0 = no discomfort; 100 = worst imaginable discomfort).
Key Clinical Findings:
- Rapid Onset of Symptom Relief: Both CBT-004 doses showed statistically significant FBS improvement as early as Day 7 — within just one week of treatment initiation
- Sustained Efficacy at Primary Endpoint: At Day 28, both doses demonstrated clinically meaningful and statistically significant FBS reduction compared to vehicle
- 0.05% dose: -23.11 points (p = 0.006) — represents ~56% improvement from baseline
- 0.075% dose: -18.76 points (p = 0.045) — represents ~51% improvement from baseline
- Persistent Benefit During Follow-Up: Even at Day 56 (4 weeks after treatment cessation), both doses maintained statistically significant symptom improvement, suggesting potential durability of effect
- Consistency Across All Time Points: FBS showed significant improvement at every measured time point (Days 7, 28, and 56) for both doses — one of the most consistent secondary endpoints in the study
Addressing a Critical Unmet Need
More Than a Billion Patients Waiting for a Real Treatment
1+ Billion Affected
Over 1 billion people globally
are affected by pinguecula
No Treatments
No FDA-approved drug therapies exist today
Phase 2 Complete
CBT-004 has achieved first-in-class
proof-of-concept
Despite its enormous global prevalence, pinguecula has been historically neglected in ophthalmic drug development.
The condition sits in a therapeutic gap, considered by many providers as “not serious enough” for intervention, yet causing real daily symptoms that affect patients’ comfort, vision quality, and quality of life. Eye care professionals currently lack any evidence-based, disease-modifying pharmacological tool to offer their patients.
Cloudbreak’s CBT-004 changes that. For the first time, a clinically validated approach that directly targets the vascular and fibrotic changes driving pinguecula could be offered with a well-tolerated topical formulation that fits seamlessly into existing eye care workflows.
One Platform,
Multiple Conditions
The same multi-kinase inhibitor mechanism that enables CBT-004’s activity in pinguecula positions Cloudbreak’s platform for broader application across anterior segment diseases characterized by abnormal fibrovascular activity. By targeting shared upstream signaling pathways — VEGF, PDGF, FGF, and TGF-β — the platform has potential utility in corneal neovascularization and other conditions where vascular and fibrotic dysregulation drives disease.
為何這對於瞼裂斑患者、專業人士
及投資者至關重要
瞼裂斑是一種慢性、有症狀的眼表疾病，影響數百萬成年人的舒適度、外觀和日常功能，它不僅僅是一個美容問題。將瞼裂斑視為一種真實的疾病狀態，而非偶然發現，突顯了它對患者的影響、對臨床實踐的需求，以及對醫療體系和支付方的更廣泛負擔。
對於患者而言，這意味著持續的刺激、紅腫和生活方式受限，且往往缺乏持久的治療選擇。對於眼科專業人員而言，它是患者頻繁就診和復診的原因，且目前主要依靠短期對症措施進行管理。對於投資者而言，龐大的未開發患者群體以及疾病修飾療法的匱乏，指向了一個意義重大的創新機會。
Cloudbreak Pharma正在推進專門設計的後期候選藥物，旨在更早地干預此疾病，目標是減輕症狀、穩定眼表，並最終減少隨著時間的推移對程序性或手術干預的需求。