Last reviewed · How we verify
Silicone Oil
Silicone Oil is a Intraocular tamponade agent Small molecule drug developed by National Eye Institute (NEI). It is currently FDA-approved for Rhegmatogenous retinal detachment with proliferative vitreoretinopathy, Complex retinal detachment, Retinal detachment with inferior breaks.
Silicone oil acts as a temporary intraocular tamponade agent that fills the vitreous cavity to support retinal reattachment and maintain eye shape during healing.
Silicone oil is being studied as a potential treatment for various scar-related conditions, including scar, keloid, hypertrophic scar, cicatrix, and proliferative vitreoretinopathy, through clinical trials such as NCT04169490. However, the exact mechanism of silicone oil is currently unknown, as indicated by ChEMBL.
At a glance
| Generic name | Silicone Oil |
|---|---|
| Sponsor | National Eye Institute (NEI) |
| Drug class | Intraocular tamponade agent |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
Mechanism of action
Silicone oil is a biocompatible, inert polymer injected into the eye to provide mechanical support and buoyancy, pushing detached retina back against the eye wall. It allows the retina to reattach while the underlying pathology (such as retinal breaks or proliferative vitreoretinopathy) is treated. The oil is eventually removed once healing is sufficient, typically after several weeks to months.
Approved indications
- Rhegmatogenous retinal detachment with proliferative vitreoretinopathy
- Complex retinal detachment
- Retinal detachment with inferior breaks
- Traumatic retinal detachment
Common side effects
- Cataract formation
- Elevated intraocular pressure
- Oil emulsification
- Corneal opacification
- Retinal toxicity
- Proliferative vitreoretinopathy recurrence
Key clinical trials
- Influence of Tamponade on Retinal Shift in Eyes Undergoing Vitrectomy for Rhegmatogenous Retinal Detachment: A Comparison of Gas Versus Silicone Oil in a Pakistani Population (NA)
- Ocular Hypotony and Refractive Predictability in RRD Surgery (NA)
- Prevention of Incontinence-associated Dermatitis (NA)
- Topical CBD Scar Healing Study (PHASE1)
- Autologous Tenon's Capsule Graft for Refractory Macular Holes (NA)
- Efficacy in Preventing Hypertrophic Scars: A Randomised Controlled Trial Comparing Chitosan Cream, Silicone Gel & Olive Oil (NA)
- Functional Performance and Acceptability Evaluation of the Miss Liberty Female Condom Compared to the FC2 Female Condom (NA)
- Topical CBD Scar Outcomes Study (EARLY_PHASE1)
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:
- Silicone Oil CI brief — competitive landscape report
- Silicone Oil updates RSS · CI watch RSS
- National Eye Institute (NEI) portfolio CI
Frequently asked questions about Silicone Oil
What is Silicone Oil?
How does Silicone Oil work?
What is Silicone Oil used for?
Who makes Silicone Oil?
What drug class is Silicone Oil in?
What development phase is Silicone Oil in?
What are the side effects of Silicone Oil?
Related
- Drug class: All Intraocular tamponade agent drugs
- Manufacturer: National Eye Institute (NEI) — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Rhegmatogenous retinal detachment with proliferative vitreoretinopathy
- Indication: Drugs for Complex retinal detachment
- Indication: Drugs for Retinal detachment with inferior breaks
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing