CLINICAL TRIALS PROFILE FOR NEVANAC

All Clinical Trials for NEVANAC

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00332774 ↗	Nevanac 3-Month Safety Study With QID Dosing	Completed	Alcon Research	Phase 3	2006-02-01	The purpose of this study is to determine the safety of Nevanac 0.1% compared to Acular LS 0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days following surgery.
NCT00333255 ↗	Nepafenac Opthalmic Suspension 0.1% Compared to Acular LS for Treatment of Inflammation After Cataract Surgery	Completed	Alcon Research	Phase 3	2005-09-01	The purpose of this study is to compare the effectiveness of Nepafenac Ophthalmic Suspension, 0.1% eye drops to Acular LS eye drops, used before and after cataract surgery, for treating inflammation in the eye.
NCT00347204 ↗	Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK	Completed	Allergan	Phase 4	2006-01-01	To determine the ability of two topical Nonsteroidal Anti-inflammatory drops (Acular LS & Nevanac) to help control pain following Photorefractive Keratectomy (PRK).
NCT00347204 ↗	Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK	Completed	Center For Excellence In Eye Care	Phase 4	2006-01-01	To determine the ability of two topical Nonsteroidal Anti-inflammatory drops (Acular LS & Nevanac) to help control pain following Photorefractive Keratectomy (PRK).
NCT00348582 ↗	Acular LS vs. Nevanac in Post op Inflammation Following Cataract Surgery	Completed	Innovative Medical	Phase 4	1969-12-31	The purpose of this study is to compare the clinical outcomes, safety and efficacy in patients randomized to receive either ketorolac or nepafanac following cataract surgery.
NCT00377546 ↗	Comparison of Vitreous Levels of Acular LS 0.04%, Xibrom 0.09%, and Nevanac 0.1%	Completed	Innovative Medical	Phase 4	1969-12-31	To compare the penetration of three different NSAIDs.
NCT00780780 ↗	Efficacy Study of Triamcinolone Associated With Nepafenac for Treatment of Diabetic Macular Edema	Completed	Federal University of São Paulo	Phase 3	2007-07-01	Diabetics retinopathy remains the major threat to sight in the working age population in the developed world. Furthermore, it is increasing as a major cause of blindness in other parts of the world, especially developing countries. Diabetic macular edema (DME) is a manifestation of diabetic retinopathy that produces loss of central vision. The triamcinolone intravitreal injection (1-4mg) is indicated to treatment of diabetic macular edema and it is considered an important treatment since it improves the visual acuity of patients with resolution of edema. Nepafenac is a non-steroidal anti-inflammatory drug (NSAID), usually sold as a prescription eye drop (0.1% solution). Nepafenac is manufactured by Alcon as Nevanac. It is approved by FDA as well as ANVISA. Pre-clinical studies suggest this medication showed efficacy to treat ocular posterior segment inflammation. The purpose of this study is evaluate the efficacy of intravitreal triamcinolone associated with nepafenac eye drops as treatment of diabetic macular edema.

Clinical Trial Conditions for NEVANAC

Condition Name

Condition Name for NEVANAC
Intervention	Trials
Cataract	7
Macular Edema	3
Intraocular Pressure	2
Cataracts	2

Condition MeSH

Condition MeSH for NEVANAC
Intervention	Trials
Cataract	10
Macular Edema	7
Edema	5
Inflammation	4

Clinical Trial Locations for NEVANAC

Trials by Country

Trials by Country for NEVANAC
Location	Trials
United States	9
Brazil	4
India	2
Mexico	2
Malaysia	2

Trials by US State

Trials by US State for NEVANAC
Location	Trials
Texas	3
Pennsylvania	2
California	1
Illinois	1
Michigan	1

Clinical Trial Progress for NEVANAC

Clinical Trial Phase

Clinical Trial Phase for NEVANAC
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	5
Phase 2	3

Clinical Trial Status

Clinical Trial Status for NEVANAC
Clinical Trial Phase	Trials
Completed	18
Unknown status	3
Recruiting	2

Clinical Trial Sponsors for NEVANAC

Sponsor Name

Sponsor Name for NEVANAC
Sponsor	Trials
Alcon Research	4
Allergan	3
Innovative Medical	2

Sponsor Type

Sponsor Type for NEVANAC
Sponsor	Trials
Other	22
Industry	11

Last updated: July 27, 2026

NEVANAC (nepafenac) clinical trials update, market analysis and generic/biosimilar outlook

NEVANAC is nepafenac ophthalmic solution, marketed for ocular pain and inflammation following cataract surgery. No new late-stage “NEVANAC-only” clinical development program can be stated from the provided information. Market and exclusivity risk also cannot be quantified without source-backed FDA and payer/revenue data.

What is NEVANAC (nepafenac) and what are its current FDA indications?

Answer: NEVANAC is an ophthalmic NSAID prodrug (nepafenac) used to reduce pain and inflammation associated with cataract surgery; it is not a systemic drug and is not part of a biosimilar class.

Which dosage form and dosing regimen define NEVANAC products?

Answer: NEVANAC is a topical ophthalmic solution with dosing tied to perioperative cataract surgery schedules (initiation before surgery and continued postoperatively).

What is the product label target endpoint in cataract trials?

Answer: Reduction of postoperative ocular pain and anterior segment inflammation assessed clinically after cataract surgery.

What is the clinical trials update for NEVANAC (latest studies, results, and trial phases)?

Answer: No NEVANAC-specific “latest clinical trials update” (phase, endpoints, results, recruitment status, or readouts) can be produced from the available input.

What trial designs have historically been used for nepafenac ophthalmics?

Answer: Randomized, controlled postoperative studies in cataract surgery patients evaluating anterior chamber inflammation and pain scores, typically with active comparator arms and vehicle controls.

Are there new combination or formulation studies for NEVANAC?

Answer: Cannot be stated from the provided information.

How big is the NEVANAC ophthalmic NSAID market and who buys it?

Answer: A quantified market size, share, and buyer segment profile cannot be produced from the provided information.

Where does revenue typically concentrate for topical ophthalmic anti-inflammatories?

Answer: Prescribing concentrates around cataract surgery throughput and physician preferences for perioperative pain control.

Which channels drive demand for cataract-related ophthalmic NSAIDs?

Answer: Ophthalmology clinics and retail distribution tied to cataract surgery schedules.

What are the competitive products to NEVANAC and how does nepafenac compare?

Answer: A sourced competitive set and comparative efficacy/safety ranking cannot be produced from the provided information.

Which drug classes compete with NEVANAC?

Answer: Topical ophthalmic NSAIDs compete head-to-head on pain/inflammation control after cataract surgery.

How do formulation and dosing differences affect switching risk?

Answer: Switching risk depends on dosing convenience, bottle size, formulary placement, and copay dynamics, but those inputs are not provided.

When does NEVANAC lose exclusivity and what is the patent expiration timeline?

Answer: A patent expiration and exclusivity timeline cannot be generated without Orange Book listing data and patent numbers.

What exclusivity protections typically matter for ophthalmic small molecules?

Answer: Patents covering drug substance, formulations, and methods of use; plus FDA exclusivities tied to regulatory milestones. Exact dates require listing data.

What patents protect NEVANAC (nepafenac) and which companies hold them?

Answer: The NEVANAC patent estate cannot be listed from the provided information.

Which patent types usually cover nepafenac ophthalmics?

Answer: Composition-of-matter, formulation-specific patents (concentration, excipients, preservatives), and method-of-use patents for perioperative dosing regimens.

What is the Orange Book status of NEVANAC, and are there ANDA Paragraph IV challenges?

Answer: Orange Book listings and any Paragraph IV challenges cannot be stated from the provided information.

Do generics exist for nepafenac ophthalmic solution?

Answer: Cannot be concluded from the provided information.

What generic entry risks exist for NEVANAC and what would a launch scenario look like?

Answer: A launch scenario with timing, likelihood, and likely at-risk claims cannot be produced without FDA- and litigation-backed inputs.

What are typical barriers to generic entry for ophthalmic solutions?

Answer: Formulation patent coverage, method-of-use claims, and regulatory data exclusivity if applicable, plus patent litigation stay/settlement structures.

What patent litigation affects NEVANAC (and who are the parties)?

Answer: No NEVANAC litigation can be identified from the provided information.

Have there been settlements or consent decrees involving nepafenac generics?

Answer: Cannot be stated.

Is NEVANAC exposed to biosimilar risk or substitution for biologics?

Answer: No. NEVANAC is a small-molecule ophthalmic NSAID and is not a biologic.

Regulatory and lifecycle risks: what could change the NEVANAC commercial outlook?

Answer: Without label-change history, safety communications, and enforcement actions, specific regulatory risks cannot be stated.

How do label updates or safety signals affect ophthalmic NSAID demand?

Answer: Demand typically declines after safety-related label restrictions, but quantified effects require sourced events.

Market projection: what is the NEVANAC demand outlook over the next 3–5 years?

Answer: A sourced 3–5 year projection cannot be produced from the provided information.

What drivers normally shape ophthalmic NSAID growth and decline?

Answer: Cataract surgery volumes, competitive intensity (including generics), formulary dynamics, and channel inventory cycles.

Key Takeaways

• NEVANAC is nepafenac ophthalmic solution for perioperative cataract pain and inflammation.
• A clinical trials update with phases, readouts, and statuses cannot be delivered from the provided information.
• A patent/exclusivity timeline, Orange Book status, Paragraph IV activity, and litigation status cannot be delivered from the provided information.
• Market size, competitive ranking, and 3–5 year projections cannot be quantified from the provided information.

FAQs

1. Is NEVANAC a steroid or an NSAID for cataract inflammation?
2. Does nepafenac require dosing before cataract surgery or only after?
3. Are ophthalmic NSAIDs like nepafenac interchangeable at the pharmacy level?
4. What data endpoints do cataract ophthalmic NSAID trials use to measure effectiveness?
5. What are the main regulatory milestones that determine ophthalmic drug competitiveness in the US?

References

No sources were provided in the prompt, so no cited references can be listed.