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Sham subtenon block

King Saud University · Phase 3 active Small molecule Under review

Sham subtenon block is a Small molecule drug developed by King Saud University. It is currently in Phase 3 development for Control of pain and inflammation in the eye.

Sham subtenon block is a procedure that mimics the administration of a local anesthetic to the eye, but does not actually administer any medication.

A sham subtenon block is a procedure used in clinical trials, specifically in the study of subtenon anesthesia for vitreoretinal surgery. The sham subtenon block typically involves the administration of either 2% lidocaine and 0.5% bupivacaine or a placebo, as part of a study to compare the effects of subtenon anesthesia with general anesthesia.

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 nameSham subtenon block
SponsorKing Saud University
ModalitySmall molecule
Therapeutic areaOphthalmology
PhasePhase 3

Mechanism of action

This procedure is used to control pain and inflammation in the eye, and is often used in conjunction with other treatments. The exact mechanism of action is not well understood, but it is thought to involve the release of natural pain-relieving chemicals in the body. By mimicking the administration of a local anesthetic, the procedure can help to reduce pain and inflammation without the need for actual medication.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Sham subtenon block

What is Sham subtenon block?

Sham subtenon block is a Small molecule drug developed by King Saud University, indicated for Control of pain and inflammation in the eye.

How does Sham subtenon block work?

Sham subtenon block is a procedure that mimics the administration of a local anesthetic to the eye, but does not actually administer any medication.

What is Sham subtenon block used for?

Sham subtenon block is indicated for Control of pain and inflammation in the eye.

Who makes Sham subtenon block?

Sham subtenon block is developed by King Saud University (see full King Saud University pipeline at /company/king-saud-university).

What development phase is Sham subtenon block in?

Sham subtenon block is in Phase 3.

What are the side effects of Sham subtenon block?

Common side effects of Sham subtenon block include Eye irritation.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing