Last reviewed 2026-04-22 · How we verify

Bromfenac Ophthalmic Solution A

Bausch & Lomb Incorporated · Phase 3 active Small molecule

Bromfenac Ophthalmic Solution A is a Nonsteroidal anti-inflammatory drug (NSAID) Small molecule drug developed by Bausch & Lomb Incorporated. It is currently in Phase 3 development for Postoperative inflammation and pain following ocular surgery, Ocular itching associated with allergic conjunctivitis.

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis and inflammation in the eye.

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis and inflammation in the eye. Used for Postoperative inflammation and pain following ocular surgery, Ocular itching associated with allergic conjunctivitis.

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	Bromfenac Ophthalmic Solution A
Sponsor	Bausch & Lomb Incorporated
Drug class	Nonsteroidal anti-inflammatory drug (NSAID)
Target	Cyclooxygenase (COX-1 and COX-2)
Modality	Small molecule
Therapeutic area	Ophthalmology
Phase	Phase 3

Mechanism of action

As a topical ophthalmic NSAID, bromfenac penetrates ocular tissues and suppresses COX-1 and COX-2 activity, thereby decreasing prostaglandin-mediated inflammatory mediators. This reduces ocular inflammation, pain, and swelling associated with surgical procedures and inflammatory conditions of the eye.

Approved indications

Postoperative inflammation and pain following ocular surgery
Ocular itching associated with allergic conjunctivitis

Common side effects

Ocular irritation or stinging
Conjunctival hyperemia
Headache
Corneal adverse events (rare)

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.

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:

Bromfenac Ophthalmic Solution A CI brief — competitive landscape report
Bromfenac Ophthalmic Solution A updates RSS · CI watch RSS
Bausch & Lomb Incorporated portfolio CI

Frequently asked questions about Bromfenac Ophthalmic Solution A

What is Bromfenac Ophthalmic Solution A?

Bromfenac Ophthalmic Solution A is a Nonsteroidal anti-inflammatory drug (NSAID) drug developed by Bausch & Lomb Incorporated, indicated for Postoperative inflammation and pain following ocular surgery, Ocular itching associated with allergic conjunctivitis.

How does Bromfenac Ophthalmic Solution A work?

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis and inflammation in the eye.

What is Bromfenac Ophthalmic Solution A used for?

Bromfenac Ophthalmic Solution A is indicated for Postoperative inflammation and pain following ocular surgery, Ocular itching associated with allergic conjunctivitis.

Who makes Bromfenac Ophthalmic Solution A?

Bromfenac Ophthalmic Solution A is developed by Bausch & Lomb Incorporated (see full Bausch & Lomb Incorporated pipeline at /company/bausch-lomb-incorporated).

What drug class is Bromfenac Ophthalmic Solution A in?

Bromfenac Ophthalmic Solution A belongs to the Nonsteroidal anti-inflammatory drug (NSAID) class. See all Nonsteroidal anti-inflammatory drug (NSAID) drugs at /class/nonsteroidal-anti-inflammatory-drug-nsaid.

What development phase is Bromfenac Ophthalmic Solution A in?

Bromfenac Ophthalmic Solution A is in Phase 3.

What are the side effects of Bromfenac Ophthalmic Solution A?

Common side effects of Bromfenac Ophthalmic Solution A include Ocular irritation or stinging, Conjunctival hyperemia, Headache, Corneal adverse events (rare).

What does Bromfenac Ophthalmic Solution A target?

Bromfenac Ophthalmic Solution A targets Cyclooxygenase (COX-1 and COX-2) and is a Nonsteroidal anti-inflammatory drug (NSAID).

Drug class: All Nonsteroidal anti-inflammatory drug (NSAID) drugs
Target: All drugs targeting Cyclooxygenase (COX-1 and COX-2)
Manufacturer: Bausch & Lomb Incorporated — full pipeline
Therapeutic area: All drugs in Ophthalmology
Indication: Drugs for Postoperative inflammation and pain following ocular surgery
Indication: Drugs for Ocular itching associated with allergic conjunctivitis

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