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Sham injection + laser
Sham injection + laser is a Small molecule drug developed by Jaeb Center for Health Research. It is currently in Phase 3 development for Treatment of psoriasis. Also known as: placebo.
This drug combines a sham injection with laser therapy, which is a non-pharmacological treatment approach.
Sham injection is a control intervention used in clinical trials for conditions such as Weiss Ring, Floaters, and Diabetic Retinopathy, often in conjunction with laser treatment. The exact mechanism of Sham injection is unknown, as it is classified as a compound solution of sodium chloride, similar to Ringer's injection, but its specific formulation and effects are not well-documented.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Sham injection + laser |
|---|---|
| Also known as | placebo |
| Sponsor | Jaeb Center for Health Research |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
The sham injection serves as a placebo control, while the laser therapy is used to stimulate tissue repair or reduce inflammation. The exact mechanism of action is not well understood, but it is thought to involve the activation of various cellular pathways that promote healing.
Approved indications
- Treatment of psoriasis
Common side effects
- Skin irritation
Key clinical trials
- A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma (PHASE3)
- Comparing Intravitreal Aflibercept Monotherapy vs Aflibercept Combined With Reduced Fluence PDT in PCV Treatment (NA)
- Nd:YAG Laser Vitreolysis for Symptomatic Vitreous Floaters (NA)
- Efficacy of a Combination of Ultrasound-guided Intra-articular Injections of Hyaluronic Acid, High-power Laser Therapy and Rehabilitation on Functioning in Patients Affected by Hip Osteoarthritis. (NA)
- A Study of BI 765128 in Patients With an Eye Condition Called Diabetic Macular Ischemia Who Have Received Laser Treatment (PHASE1, PHASE2)
- Photobiomodulation and the Intralesional Administration of Corticoid in the Keloid Surgery. (NA)
- Extracorporeal Shock Wave Therapy Versus High Power LASER Therapy for the Treatment of Females With Calcaneal Spur (NA)
- Photobiomodulation for Controlling Pre-Local Anesthetic Injection Pain (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sham injection + laser CI brief — competitive landscape report
- Sham injection + laser updates RSS · CI watch RSS
- Jaeb Center for Health Research portfolio CI
Frequently asked questions about Sham injection + laser
What is Sham injection + laser?
How does Sham injection + laser work?
What is Sham injection + laser used for?
Who makes Sham injection + laser?
Is Sham injection + laser also known as anything else?
What development phase is Sham injection + laser in?
What are the side effects of Sham injection + laser?
Related
- Manufacturer: Jaeb Center for Health Research — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Treatment of psoriasis
- Also known as: placebo
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing