Sham Avastin Intravitreal Injection

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA · Phase 3 active Small molecule

Sham Avastin Intravitreal Injection is a Small molecule drug developed by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA. It is currently in Phase 3 development for Sham control arm in phase 3 trials (not a therapeutic indication). Also known as: Sham.

This is a sham (placebo) intravitreal injection used as a control in clinical trials, containing no active pharmaceutical ingredient.

This is a sham (placebo) intravitreal injection used as a control in clinical trials, containing no active pharmaceutical ingredient. Used for Sham control arm in phase 3 trials (not a therapeutic indication).

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

• 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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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 Avastin Intravitreal Injection
Also known as	Sham
Sponsor	Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Modality	Small molecule
Therapeutic area	Ophthalmology
Phase	Phase 3

Mechanism of action

Sham Avastin refers to a placebo comparator in phase 3 clinical trials evaluating intravitreal bevacizumab (Avastin). The sham injection mimics the administration procedure of the active drug but delivers an inert substance, allowing researchers to isolate the true therapeutic effect of bevacizumab from procedural and expectation effects in ophthalmologic conditions.

Approved indications

• Sham control arm in phase 3 trials (not a therapeutic indication)

Common side effects

No common side effects on file.

Key clinical trials

• A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy (PHASE3)
• Pre-operative Vabysmo in Patients With Non-clearing Vitreous Hemorrhage Secondary to Proliferative Diabetic Retinopathy (PHASE4)
• Initial Treatment With Bevacizumab in Choroidal Neovascularization Associated to High Myopia (PHASE3)
• Additional Effect of Subthreshold Micropulse Laser to Intravitreous Injection of Bevacizumab on Diabetic Macular Edema (PHASE2, PHASE3)
• Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO (PHASE3)
• Laser vs Bevacizumab Injection Alone in Treatment of Diabetic Macular Edema (PHASE2, PHASE3)
• Phase 2 Randomized Clinical Trial of Luminate® as Compared to Avastin® in the Treatment of Diabetic Macular Edema (PHASE2)
• Avastin for PDR (Proliferative Diabetic Retinopathy) (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 Avastin Intravitreal Injection CI brief — competitive landscape report
• Sham Avastin Intravitreal Injection updates RSS · CI watch RSS
• Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA portfolio CI

Frequently asked questions about Sham Avastin Intravitreal Injection

What is Sham Avastin Intravitreal Injection?

Sham Avastin Intravitreal Injection is a Small molecule drug developed by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA, indicated for Sham control arm in phase 3 trials (not a therapeutic indication).

How does Sham Avastin Intravitreal Injection work?

This is a sham (placebo) intravitreal injection used as a control in clinical trials, containing no active pharmaceutical ingredient.

What is Sham Avastin Intravitreal Injection used for?

Sham Avastin Intravitreal Injection is indicated for Sham control arm in phase 3 trials (not a therapeutic indication).

Who makes Sham Avastin Intravitreal Injection?

Sham Avastin Intravitreal Injection is developed by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA (see full Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA pipeline at /company/instituto-universitario-de-oftalmobiolog-a-aplicada-institute-of-applied-ophthal).

Is Sham Avastin Intravitreal Injection also known as anything else?

Sham Avastin Intravitreal Injection is also known as Sham.

What development phase is Sham Avastin Intravitreal Injection in?

Sham Avastin Intravitreal Injection is in Phase 3.

Related

• Manufacturer: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA — full pipeline
• Therapeutic area: All drugs in Ophthalmology
• Indication: Drugs for Sham control arm in phase 3 trials (not a therapeutic indication)
• Also known as: Sham