Eyeworld

12 EW ASCRS NEWS December 2016 A retrospective on EyeWorld's news coverage as part of the 20th anniversary celebration F rom its start, EyeWorld has provided practitioners with top-notch practical insights for improving ophthalmic care. While this remains constant, EyeWorld's news coverage has evolved over the years under the guidance of its medical editors. Here, we take a closer look at how EyeWorld has grown since 1996. EyeWorld's early days When Stephen Obstbaum, MD, became chief medical editor in 2002, joining Marguerite McDonald, MD, who had been the medical editor from the 1996 inaugural issue, the idea was to broaden EyeWorld's cover- age. "The feeling was that we wanted to give greater exposure to glaucoma and cataract," Dr. Obstbaum said. "Don Long, EyeWorld publisher, and Dave Karcher, ASCRS executive director, felt that bringing someone else in to complement Marguerite's strengths in cornea and refractive surgery would be beneficial." The idea was to include arti- cles featuring more of the anterior segment in EyeWorld. "Rather than just talking about cornea, refractive, and, of course, cataract—which was pervasive in everything that we did—we also sought to emphasize glaucoma, and to support the newly formed Glaucoma Clinical Commit- tee," Dr. Obstbaum said, adding that EyeWorld would be a vehicle for in- dividuals to present their work and give other practitioners the opportu- nity to learn about it. At the time, most of the other ophthalmic periodicals were ave- nues for information that in many instances were derived from com- mercial interests, Dr. Obstbaum noted. "For example, if a company wanted to promulgate information on a new drug or device, it might request to publish an article report- ing the results of the study in one or more of the periodicals. Our feeling was that it was important to present this information to our readers and we weren't going to put the kibosh on that as a resource, but whatever we wrote would be commented on by several sources," he said. "Some- times this was unpopular with the sponsoring group, but they came around to it because we tried to do it in an even-handed manner." Over time, the EyeWorld lead- ership continued to change. "After Marguerite retired as medical editor, I joined with Stephen Lane, MD, and Edward Holland, MD, who are INDICATIONS AND USAGE PROLENSA ® (bromfenac ophthalmic solution) 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. DOSAGE AND ADMINISTRATION Recommended Dosing One drop of PROLENSA ® ophthalmic solution should be applied to the affected eye once daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 14 days of the postoperative period. Use with Other Topical Ophthalmic Medications PROLENSA ophthalmic solution may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta- blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart. CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Sulfite Allergic Reactions 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 non- asthmatic people. Slow or Delayed Healing All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including bromfenac, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. Potential for Cross-Sensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including bromfenac. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs. Increased Bleeding Time With some NSAIDs, including bromfenac, there exists the potential for increased bleeding time due to interference with platelet aggregation. There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that PROLENSA ® ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. Keratitis and Corneal Reactions Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including bromfenac, and should be closely monitored for corneal health. Post-marketing experience with topical NSAIDs suggests that 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 also 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. Contact Lens Wear PROLENSA should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of PROLENSA. The preservative in PROLENSA, benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of PROLENSA. ADVERSE REACTIONS Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The most commonly reported adverse reactions following use of PROLENSA ® ophthalmic solution following cataract surgery include: anterior chamber inflammation, foreign body sensation, eye pain, photophobia and vision blurred. These reactions were reported in 3 to 8% of patients. USE IN SPECIFIC POPULATIONS Pregnancy Treatment of rats at oral doses up to 0.9 mg/kg/day (systemic exposure 90 times the systemic exposure predicted from the recommended human ophthalmic dose [RHOD] assuming the human systemic concentration is at the limit of quantification) and rabbits at oral doses up to 7.5 mg/kg/day (150 times the predicted human systemic exposure) produced no treatment-related malformations in reproduction studies. However, embryo-fetal lethality and maternal toxicity were produced in rats and rabbits at 0.9 mg/kg/day and 7.5 mg/kg/day, respectively. In rats, bromfenac treatment caused delayed parturition at 0.3 mg/kg/day (30 times the predicted human exposure), and caused dystocia, increased neonatal mortality and reduced postnatal growth at 0.9 mg/kg/day. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the known effects of prostaglandin biosynthesis- inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of PROLENSA ® ophthalmic solution during late pregnancy should be avoided. Nursing Mothers Caution should be exercised when PROLENSA is administered to a nursing woman. Pediatric Use Safety and efficacy in pediatric patients below the age of 18 have not been established. Geriatric Use There is no evidence that the efficacy or safety profiles for PROLENSA differ in patients 70 years of age and older compared to younger adult patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis and Impairment of Fertility Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up to 0.6 mg/kg/day (systemic exposure 30 times the systemic exposure predicted from the recommended human ophthalmic dose [RHOD] assuming the human systemic concentration is at the limit of quantification) and 5 mg/kg/day (340 times the predicted human systemic exposure), respectively, revealed no significant increases in tumor incidence. Bromfenac did not show mutagenic potential in various mutagenicity studies, including the reverse mutation, chromosomal aberration, and micronucleus tests. Bromfenac did not impair fertility when administered orally to male and female rats at doses up to 0.9 mg/kg/day and 0.3 mg/kg/day, respectively (systemic exposure 90 and 30 times the predicted human exposure, respectively). PATIENT COUNSELING INFORMATION Slowed or Delayed Healing Advise patients of the possibility that slow or delayed healing may occur while using NSAIDs. Sterility of Dropper Tip Advise patients to replace bottle cap after using and to not touch dropper tip to any surface, as this may contaminate the contents. Advise patients that a single bottle of PROLENSA ® ophthalmic solution, be used to treat only one eye. Concomitant Use of Contact Lenses Advise patients to remove contact lenses prior to instillation of PROLENSA. The preservative in PROLENSA, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of PROLENSA. Concomitant Topical Ocular Therapy If more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart. Rx Only Manufactured by: Bausch & Lomb Incorporated, Tampa, FL 33637 Under license from: Senju Pharmaceuticals Co., Ltd. Osaka, Japan 541-0046 Prolensa is a trademark of Bausch & Lomb Incorporated or its affiliates. © Bausch & Lomb Incorporated. 9317600 US/PRA/14/0024 PROLENSA ® (bromfenac ophthalmic solution) 0.07% Brief Summary S:7" S:10" T:7.75" T:10.75" B:7.75" BAUS2534 PROLENSA Journal Ad OSN B/W Island Page Live: .25" from trim File Format: PDF/X-1a Carling Communications 3/9/2016 by Maxine Lipner EyeWorld Senior Contributing Writer EyeWorld growing, changing, and evolving over time

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