Last reviewed 2026-06-02 · How we verify

Prednefrin

Laboratorios Sophia S.A de C.V. · Phase 3 active Small molecule ✓ Verified Jun 2026

Prednefrin is a Small molecule drug developed by Laboratorios Sophia S.A de C.V.. It is currently in Phase 3 development. Also known as: Difluprednate.

Prednefrin is an ophthalmic emulsion used to treat inflammation and pain after phacoemulsification, a type of cataract surgery. It is administered in combination with difluprednate 0.05% in clinical studies.

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	Prednefrin
Also known as	Difluprednate
Sponsor	Laboratorios Sophia S.A de C.V.
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 3

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Clinical Study of the Efficacy of the Ophthalmic Emulsion PRO-145 for Inflammation and Pain After Phacoemulsification (PHASE3)

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:

Prednefrin CI brief — competitive landscape report
Prednefrin updates RSS · CI watch RSS
Laboratorios Sophia S.A de C.V. portfolio CI

Frequently asked questions about Prednefrin

What is Prednefrin?

Prednefrin is a Small molecule drug developed by Laboratorios Sophia S.A de C.V..

Who makes Prednefrin?

Prednefrin is developed by Laboratorios Sophia S.A de C.V. (see full Laboratorios Sophia S.A de C.V. pipeline at /company/laboratorios-sophia-s-a-de-c-v).

Is Prednefrin also known as anything else?

Prednefrin is also known as Difluprednate.

What development phase is Prednefrin in?

Prednefrin is in Phase 3.

Manufacturer: Laboratorios Sophia S.A de C.V. — full pipeline
Therapeutic area: All drugs in Other
Also known as: Difluprednate

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