Eyeworld Weekly Update

RESEARCH BRIEFS

• A preliminary study on a Tie2 activator administered subcutaneously for 28 days as monotherapy in patients with diabetic macular edema (DME) was well-tolerated and produced clinically meaningful reductions in retinal thickness, correlating with improved visual acuity, according to study authors. Peter Campochiaro, MD, and colleagues evaluated AKB-9778, a first-in-class inhibitor of human protein tyrosine phosphatase beta (HPTPβ) that activates the Tie2 pathway to promote vascular stability, preventing abnormal blood vessel growth and vascular leakage, in 4 dose cohorts. Six patients in each cohort self-administered subcutaneous injections of 5 mg, 15 mg, 22.5 mg, or 30 mg AKB-9778 twice daily for 4 weeks. All doses were well tolerated. At 1 month, 7 out of 18 patients receiving doses of 15 mg or higher demonstrated a reduction in central subfield thickness (CST) in the study eye of greater than 50 µm, and 13 out of 18 patients gained 5 or more letters of visual acuity in the study eye as measured by the best corrected visual acuity (BCVA) assessment. Among 18 patients receiving 15 mg or more twice daily, CST decreased by more than 100 μm in 5 patients and by 50 to 100 μm in 2 patients. There was a significant correlation between reduction in CST and improvement in BCVA. The study is published in Ophthalmology.
• The Global Delphi Panel of Keratoconus and Ectatic Diseases has published its recommendations on keratoconus and ectatic diseases in Cornea. The panel stated that despite extensive knowledge regarding the diagnosis and management of keratoconus and ectatic corneal diseases, many controversies still exist, and that led to the development of these guidelines. Numerous agreements (defined as a 2/3 majority among subpanel members) were generated in definitions, methods of diagnosing, and management of keratoconus and other ectatic diseases. Nonsurgical and surgical treatments for these conditions, including the use of corneal crosslinking and corneal transplantations, were presented in a stepwise approach. A flowchart describing a logical management sequence for keratoconus was created.
• Femtosecond pretreatment caused a greater transient rise in intraocular pressure (IOP) after treatment and a higher residual IOP after vacuum undocking in glaucomatous eyes than in non-glaucomatous eyes, according to Erica Darian-Smith and colleagues. In their nonrandomized, interventional, prospective case series, they compared results from 143 eyes (97 patients). Pretreatment was performed using a fluid-filled optical docking system (Liquid Optics Interface). With the patient supine, the IOP was measured at 4 time points using a rebound tonometer (Icare Pro). Forty-three eyes (30.1%) had documented glaucoma. The mean baseline IOP was 20.2 mm Hg±4.2 in glaucomatous eyes and 18.9±4.0 mm Hg in non-glaucomatous eyes (P=.06). The mean change in IOP values between each timeframe and baseline was as follows: vacuum-on, 13.8±9.9 mm Hg and 11.1±6.9 mm Hg, respectively (P=.06); after treatment, 17.4±7.4 mm Hg and 14.1±7.2 mm Hg, respectively (P=.014); after undocking of vacuum, 9.9±5.4 mm Hg and 8.7±5.7 mm Hg, respectively (P=.24). The study authors cautioned that longer term implications remain unknown. The study is published in the Journal of Cataract & Refractive Surgery.

Important Safety Information about PROLENSA® 

• PROLENSA® contains sodium sulfite, a sulfite that may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
• All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including bromfenac, may slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
• There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including bromfenac. Use with caution in patients who have previously exhibited sensitivities to these drugs. 
• There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. Use with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. 
• Use of topical NSAIDs may result in keratitis. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including bromfenac, and should be closely monitored for corneal health. Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Post-marketing experience with topical NSAIDs suggests that use more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events. 
• PROLENSA® should not be instilled while wearing contact lenses. The preservative in PROLENSA®, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of PROLENSA®. 
• The most commonly reported adverse reactions in 3%-8% of patients were anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and blurred vision.