Evaluation of Xibrom Bromfenac Ophthalmic Solution 0'09% for the Treatment of Corneal Ulcer Pain

1
Evaluation of Xibrom (Bromfenac Ophthalmic
Solution) 0.09 for the Treatment of Corneal
Ulcer Pain
B.A. Schechter Florida Eye Microsurgical
Institute, Boynton Beach, FL
Percentage of Patients Pain Free
INTRODUCTION
RESULTS

• Corneal Ulcer Pain Treatment
• Pain due to infectious keratitis may be quite
  debilitating
• Patients may have trouble sleeping and completing
  normal daily tasks
• If this pain was controlled, patients could
  return to work sooner and have less disruption of
  their daily activities
• Ophthalmic nonsteroidal anti-inflammatory drugs
  (NSAIDs), have been shown to provide effective
  pain relief for traumatic corneal abrasions1-4
• There is no published literature on the use of
  ophthalmic NSAIDs to control pain associated with
  corneal ulceration
• The use of topical steroids to treat corneal
  ulcers remains controversial5-6 and does little
  to relieve pain

Xibrom BID
N18
All 18 corneal ulcers healed
Days
2
3
7
72
0
Median Time to Pain Resolution
No corneal adverse events occured

• All eighteen corneal ulcers healed (range 7-72
  days)
• Associated ulcer pain was reduced from a range of
  2-4 to 0 without oral opiates
• Median time to pain resolution was 3 days
• Pain resolved as fast as treatment Day 1 in some
  patients
• Median time subjects resumed regular activity was
  2 days after treatment initiation
• Some patients returned to work or school after 1
  treatment day.
• No corneal adverse events occurred

Median Time to Resume Regular Activities
Figure 2. Fluorescein staining shows a large
epithelial defect
Figure 4. Final acuity of 20/200
PURPOSE
CONCLUSION

• To evaluate the efficacy and safety of bromfenac
  ophthalmic solution (Xibrom) 0.09 for treating
  pain associated with corneal ulcers

• Xibrom (bromfenac ophthalmic solution) 0.09
• was effective in treating pain associated with
• corneal ulceration and did not delay corneal
• epithelialization nor cause any corneal adverse
• events in this group of 18 patients.

METHODS
RESULTS (CASE STUDY)

• Eighteen eyes with corneal infiltrates (bacterial
  or fungal) were treated with topical
  anti-infectives
• Bromfenac (Xibrom) b.i.d. was started
  concurrently to treat the accompanying pain
• Follow-up was determined by the severity of
  disease
• Frequently in first 2 weeks
• Then at least weekly for 4 months or until
  infiltrates resolved
• Measurements
• Best corrected visual acuity (BCVA)
• Location, size, and density of corneal
  infiltrates
• Size and presence of a corneal epithelial defect
• Subjective eye pain (scale of 0-4) and time to
  pain resolution
• Ability to resume regular activity
• Adverse events recorded

Figure 3. 2/16/06 After one month of
anti-fungals and bromfenac, infiltrate resolving
REFERENCES

• Calder LA, Balasubramanian S, Fergusson D. Acad
  Emerg Med 2005l12(5)467-473.
• Jayamanne DGRm Fitt AWD, Dayan M, et al. Eye
  19971179-83.
• Goyal R, Shankar J, Fone DL, et al. Acta
  Ophthalmol Scand 200179177-9.
• Patrone G, Sacca SC, Macri A, et al.
  Ophthalmologica 1999213350-4.
• Bourcier T, Forgez P, Borderie V, et al Invest
  Ophthalmol Vis Sci 2000414133-4141.
• Baum J, Dabezies OH Jr. Cornea 200019777-781.

Figure 1. 17 year old, female had been treated
with tobramycin and Dexamethasone. Presented on
1/12/06 with corneal infiltrate and hypopyon
which grew out Fusarium
Presented at ASCRS, April 27-May 2, 2007, San
Diego, CA
Figure 5. Bromfenac did not hinder
epithelialization 3/02/06