CLINICAL TRIALS PROFILE FOR XIBROM

All Clinical Trials for Xibrom

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00438243 ↗	Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-operative Cystoid Macular Edema.	Withdrawn	Johns Hopkins University	Phase 2	2008-05-01	This research is being done to look at the effects of Bromfenac, also called Xibrom for the treatment of swelling in the retina (the light sensitive tissue in the back of the eye) called "macular edema" that occurs after cataract surgery. Swelling in the retina can lead to blurry vision. The most commonly used treatment is eyedrops that decrease inflammation and may help stop some of the swelling. The investigators want to see if the drug Bromfenac(Xibrom) can decrease the swelling in the retina after cataract surgery and improve vision in these patients.
NCT00698724 ↗	Comparing Optical Coherence Tomography (OCT) and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Sta	Completed	Bp Consulting, Inc	Phase 4	2008-06-01	To compare the efficacy of twice-daily topical bromfenac (Xibrom) ophthalmic solution alone versus twice-daily topical Xibrom with prednisolone acetate 1% three-times daily on visual acuity and OCT measurements.
NCT00758199 ↗	Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery	Completed	Bp Consulting, Inc	Phase 4	2008-07-01	The objective of this study is to determine if an extension of bromfenac BID monotherapy is effective in the decreasing retinal thickening post cataract IOL placement surgery. No studies exist on how long to treat with an NSAID post cataract IOL placement surgery. Currently, NSAID therapy post IOL placement surgery is in conjunction with steroid treatment, lasting approximately 3 weeks. This study is designed to examine if there is benefit to extending NSAID monotherapy in regards to macular thickening and the incidence of CME.
NCT00758628 ↗	Randomized, Double Blind Trial of Bromfenac BID (0.09%) as an Adjunct to Argon Laser Therapy in the Treatment of Diabetic Macular Edema.	Completed	Bp Consulting, Inc	Phase 4	2008-08-01	: The objective of this study is to determine if bromfenac reduces diabetic macular edema (DME) as an adjunct to argon laser therapy (ALT). Leading cause of Blindness in the working-aged population in the United States. 60% of patients with Type-II DM, and nearly all with Type-I DM progress to Diabetic Retinopathy (DR) in twenty years. Diabetic Macular Edema is the principal cause of vision loss in DR. Approximately 50% of patients with DME will experience a loss of >=2 lines of best-corrected visualacuity (VA) after 2 years of follow-up. The pathogenesis of DME is multifactorial and complex, but intervention stratagem have tended to be singular. Photocoagulation laser applied directly to leaking microaneurysms and a "grid" of laser has been the mainstays of treatment since the publication of the Early Treatment Diabetic Retinopathy Study (ETDRS). This landmark clinical trial was an NIH sponsored, multicenter, controlled study that demonstrated efficacy of laser for diabetic macular edema. It also demonstrated that 20% of patients did not respond. Recent efforts to improve the results are focusing on pharmaceutical interventions injected into the vitreous cavity. The route of administration and lack of substantiated efficacy are problematic.
NCT00828477 ↗	Evaluation of Comfort With Xibrom (Bromfenac Ophthalmic Solution)0.09% and Nevanac (Nepafenac Ophthalmic Suspension) 0.1% Following Selective Laser Trabeculoplasty (SLT)	Completed	Bp Consulting, Inc	Phase 4	2009-01-01	The objective of this study is to evaluate and compare the comfort of bromfenac or nepafenac following SLT.

Clinical Trial Conditions for Xibrom

Condition Name

Condition Name for Xibrom
Intervention	Trials
Cataracts	4
Cystoid Macular Edema	1
Diabetic Macular Edema	1
Intraocular Pressure	1

Condition MeSH

Condition MeSH for Xibrom
Intervention	Trials
Cataract	5
Macular Edema	2
Edema	2
Inflammation	1

Clinical Trial Locations for Xibrom

Trials by Country

Trials by Country for Xibrom
Location	Trials
United States	7

Trials by US State

Trials by US State for Xibrom
Location	Trials
Pennsylvania	1
Michigan	1
New York	1
California	1
Florida	1

Clinical Trial Progress for Xibrom

Clinical Trial Phase

Clinical Trial Phase for Xibrom
Clinical Trial Phase	Trials
Phase 4	7
Phase 2	1
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Xibrom
Clinical Trial Phase	Trials
Completed	8
Withdrawn	1

Clinical Trial Sponsors for Xibrom

Sponsor Name

Sponsor Name for Xibrom
Sponsor	Trials
Bp Consulting, Inc	4
Allergan	2
Frank A. Bucci, Jr., M.D.	2

Sponsor Type

Sponsor Type for Xibrom
Sponsor	Trials
Other	7
Industry	5

Xibrom (Bromfenac Ophthalmic Solution): Clinical Trials, Market Analysis, and Projections

Introduction to Xibrom

Xibrom, also known as bromfenac ophthalmic solution, is a nonsteroidal anti-inflammatory drug (NSAID) specifically designed for ophthalmic use. It is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery[1][4].

Clinical Trials and Efficacy

Mechanism of Action and Pharmacokinetics

Bromfenac works by inhibiting cyclooxygenase 1 and 2, which are enzymes responsible for prostaglandin synthesis. Prostaglandins are mediators of intraocular inflammation, and by blocking their production, bromfenac reduces ocular inflammation and pain[1].

Key Clinical Trials

Several clinical trials have demonstrated the efficacy of Xibrom in reducing ocular inflammation and pain post-cataract surgery. Two randomized, double-masked, vehicle-controlled U.S. trials involved patients with a summed ocular inflammation score ≥ 3 after cataract surgery. These trials showed that Xibrom significantly reduced ocular inflammation compared to the vehicle group (62-66% vs. 40-48%)[1][4].

In another set of Phase III clinical trials, a once-daily formulation of Xibrom was evaluated against a placebo in over 500 patients. The results indicated that the once-daily formulation was superior to the placebo in achieving the primary efficacy endpoint of absence of ocular inflammation 15 days following surgery and the secondary endpoint of elimination of ocular pain at day one[3].

Safety and Tolerability

The clinical trials also highlighted the safety profile of Xibrom. The drug produced a lower overall incidence of ocular adverse events compared to the placebo. However, it is recommended to use Xibrom with caution in patients with known bleeding tendencies or those receiving other medications that may prolong bleeding time[4].

Market Analysis

Market Position and Prescription Trends

As of the fall of 2010, Xibrom was the most prescribed branded ocular NSAID in the United States for use following cataract surgery, according to data from IMS Health[5].

Transition to Once-Daily Formulation

In November 2010, ISTA Pharmaceuticals launched a once-daily formulation of Xibrom, which quickly gained traction. By the end of January 2011, 46% of new prescriptions for the twice-daily formulation had been converted to the once-daily formulation. This transition was facilitated by the company's decision to discontinue the twice-daily formulation, with a limited supply available until inventory was depleted[5].

Pricing and Availability

Xibrom is available in various packaging options, including 5ml and 2.5ml bottles. The pricing varies, with a 5ml bottle costing around $289.59 and a 2.5ml bottle costing approximately $148.56[2].

Market Projections

Market Demand and Growth

The demand for ocular NSAIDs like Xibrom is expected to grow due to the increasing number of cataract surgeries performed globally. The aging population and advancements in surgical techniques are driving this trend.

Competitive Landscape

Xibrom competes with other ocular NSAIDs such as diclofenac and ketorolac. However, its once-daily formulation and strong clinical trial data have positioned it favorably in the market. The exclusive marketing rights granted by the FDA for the once-daily formulation have further strengthened its market position[3][5].

Future Developments

Given the success of the once-daily formulation, it is likely that ISTA Pharmaceuticals and other manufacturers will continue to innovate and improve their products. This could include further research into long-term efficacy, safety in broader patient populations, and potential applications in other ophthalmic conditions.

Regulatory Considerations

Pregnancy and Nursing Mothers

Xibrom should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as there are no adequate and well-controlled studies in pregnant women. Caution is also advised when administering Xibrom to nursing mothers due to the potential effects on the fetal cardiovascular system[1][4].

Pediatric and Geriatric Use

The safety and efficacy of Xibrom in pediatric patients below the age of 18 have not been established. There is no evidence that the efficacy or safety profiles differ in patients 65 years and older[4].

Key Takeaways

• Clinical Efficacy: Xibrom has demonstrated significant efficacy in reducing ocular inflammation and pain post-cataract surgery.
• Market Position: It was the most prescribed branded ocular NSAID in the U.S. for cataract surgery as of 2010.
• Formulation Transition: The once-daily formulation has been well-received and has largely replaced the twice-daily formulation.
• Safety Profile: Xibrom has a favorable safety profile but should be used with caution in certain patient groups.
• Market Growth: The demand for Xibrom is expected to grow with the increasing number of cataract surgeries.

FAQs

What is Xibrom used for?

Xibrom is used for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery[1].

How is Xibrom administered?

Xibrom is administered as one drop to the affected eye, twice daily, beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period[1].

What are the potential side effects of Xibrom?

Xibrom can cause ocular adverse events, and its use should be cautious in patients with known bleeding tendencies or those receiving other medications that may prolong bleeding time[4].

Can Xibrom be used during pregnancy?

Xibrom should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as there are no adequate and well-controlled studies in pregnant women[1][4].

Is Xibrom safe for pediatric patients?

The safety and efficacy of Xibrom in pediatric patients below the age of 18 have not been established[4].

Sources

1. RxList: Xibrom (Bromfenac Ophthalmic Solution) - RxList.
2. DrugBank: Bromfenac: Uses, Interactions, Mechanism of Action - DrugBank.
3. Biospace: ISTA Pharmaceuticals, Inc. Presents Results from Two Phase III Clinical Trials of Xibrom(TM) QD.
4. FDA: XIBROM™ (bromfenac ophthalmic solution) 0.09% - FDA.
5. Ophthalmology Times: BID bromfenac discontinued - Ophthalmology Times.