From the Editor: Medicine Needs the National Labor Relations Board

Most of us are aware that recently, the National Labor Relations Board (NLRB) looked at college football at Northwestern University and essentially opened the door to organized labor representation of student athletes. Despite generous scholarships, it appeared that the NLRB regarded these athletes as indentured servants of the universities they played for, helping make countless dollars for their respective institutions.

This made me think that although there were certainly differences, one could draw an analogy to the relationship physicians have with Medicare. As a physician, I receive monetary support from the U.S. government for meeting the obligations I signed on for—namely providing care to Medicare recipients who have for decades paid into a system via taxes, expecting care in the future. The NLRB review observed that student athletes put in significant hours on a weekly basis and essentially brought greater value to their institutions than the value of their scholarships. Sounds somewhat like what physicians (who accept Medicare) offer our government. Realistically, Medicare represents a significant portion of most physicians' revenue. That is a fact, but without adequate participation by America’s physicians, the government would fall well short of meeting its obligations to Medicare recipients. If we view matters in that light, we may just possibly be subjected to fewer shenanigans than what recently took place in Congress with the “SGR repeal” attempt.

Maybe we need to have the NLRB take a look at our situation. You never know what the outcome may be. What do we have to lose?

Stephen Pascucci, MD, FACS

Use of Intravitreal Aflibercept Injection for the Treatment of Macular Edema due to CRVO

The authors of the following randomized, double-masked, Phase III trial included 188 patients with macular edema secondary to central retinal vein occlusion (CRVO) to evaluate the efficacy and safety of intravitreal aflibercept injection (IAI) for the treatment of macular edema secondary to CRVO.

Patients received IAI 2 mg (IAI 2.q.4.) (n=114) or sham injections (n=74) every four weeks up to week 24. During weeks 24 to 52, patients from both arms were evaluated monthly and received IAI p.r.n. (IAI 2Q4 + p.r.n. and sham + IAI p.r.n.). During weeks 52 to 100, patients were evaluated at least quarterly and received IAI p.r.n. The primary efficacy endpoint was the proportion of patients who gained ≥15 letters in best-corrected visual acuity (BCVA) from baseline to week 24. This study reports week 100 results.

The study authors reported that the proportion of patients gaining ≥15 letters was 56.1% versus 12.3% (p<0.001) at week 24, 55.3% vs. 30.1% (p<0.001) at week 52, and 49.1% vs. 23.3% (p<0.001) at week 100 in the IAI 2Q4 + p.r.n. and sham + IAI p.r.n. groups, respectively. The mean change from baseline BCVA was also significantly higher in the IAI 2Q4 + p.r.n. group compared with the sham + IAI p.r.n. group at week 24 (+17.3 vs. –4.0 letters; p<0.001), week 52 (+16.2 vs. +3.8 letters; p<0.001), and week 100 (+13.0 vs. +1.5 letters; p<0.0001). The mean reduction from baseline in central retinal thickness was 457.2 vs. 144.8 µm (p<0.001) at week 24, 413.0 vs. 381.8 µm at week 52 (p=0.546), and 390.0 vs. 343.3 µm at week 100 (p=0.366) in the IAI 2Q4 + p.r.n. and sham + IAI p.r.n. groups, respectively. The mean number (standard deviation) of p.r.n. injections in the IAI 2Q4 + p.r.n. and sham + IAI p.r.n. groups was 2.7 ± 1.7 vs. 3.9 ± 2.0 during weeks 24 to 52 and 3.3 ± 2.1 versus 2.9 ± 2.0 during weeks 52 to 100, respectively. The most frequent ocular serious adverse event from baseline to week 100 was vitreous hemorrhage (0.9% vs. 6.8% in the IAI 2.q.4. + p.r.n. and sham + IAI p.r.n. groups, respectively).

The visual and anatomic improvements after fixed dosing through week 24 and p.r.n. dosing with monthly monitoring from weeks 24 to 52 were diminished after continued p.r.n. dosing, with a reduced monitoring frequency from weeks 52 to 100.

SOURCE: Heier JS, Clark WL, Boyer DS, et al. Intravitreal aflibercept injection for macular edema due to central retinal vein occlusion: two-year results from the COPERNICUS study. Ophthalmology. 2014;Mar 27. [Epub ahead of print].

Changes in Choroidal Thickness Following Trabeculectomy in PACG

Chinese investigators evaluated changes in choroidal thickness (CT) in advanced or late-stage primary angle-closure glaucoma (PACG) patients who underwent trabeculectomy.

The study included 23 eyes with PACG that required trabeculectomy. The investigators used enhanced depth imaging optical coherence tomography (EDI-OCT) to measure CT before and seven days after trabeculectomy. They also explored the relationships between changes in CT and changes in intraocular pressure (IOP) and axial length (AL).

At all nine macular locations, CT was significantly higher after trabeculectomy, with the exception of two sites, the investigators reported. They noted that CT at locations close to the macula exhibited a greater increase after surgery (except the inferior location), although there were no significant differences when compared to locations farther from the macula. They also found that mean CT (standard deviation) under the fovea before and after the surgery was 282.3 (42.4) µm and 311.6 (59.9) µm, respectively. Additionally, the study investigators observed that the mean IOP (standard deviation) decreased from 25.9 (11.0) mmHg (with 5.0 [1.2] kinds of anti-glaucomatous medications) to 11.8 (3.2) mmHg (without antiglaucomatous medications), which positively related to the shortened axial length after surgery (p=0.019). However, the changes in CT were not correlated with either IOP or AL.

To conclude, short-term CT increased following trabeculectomy in PACG, but it was not related to decreased IOP or shortened AL. The potential role and the significance of CT increase after trabeculectomy remains to be interpreted.

SOURCE: Chen S, Wang W, Gao X, et al. Changes in choroidal thickness after trabeculectomy in primary angle-closure glaucoma. Invest Ophthalmol Vis Sci. 2014; Mar 27. [Epub ahead of print].

Link Between Genetic Polymorphisms of the Prostaglandin F2α Receptor Gene and Response to Latanoprost in Patients with Glaucoma + OH

Researchers in Japan examined whether intraocular pressure (IOP) reduction by latanoprost correlates with single nucleotide polymorphisms (SNPs) of the prostaglandin F2α (FP) receptor gene in patients with glaucoma and ocular hypertension (OH). They found an association between SNPs of the FP receptor gene and the response to latanoprost in patients with glaucoma or OH.

The researchers determined the genotype of nine SNPs in the FP receptor gene by direct DNA sequencing, or other techniques, in 82 patients with glaucoma or OH who were treated with latanoprost monotherapy in one eye. They evaluated IOP reduction by the percent IOP reduction (%ΔIOP), estimated by subtracting IOP fluctuations in the untreated fellow eye. They also classified subjects by %ΔIOP into low responders (% ΔIOP<10%) and others (% ΔIOP ≥10%). Finally, the researchers analyzed the correlation between % ΔIOP and SNPs in the FP receptor gene.

According to the study researchers, multiple regression analysis demonstrated that the rs12093097 was the only significant factor that correlated with %ΔIOP (p=0.039). Among estimated haplotypes, one haplotype that contained the minor allele only in rs3753380, was significantly correlated with low responders even after correction for multiple test (permutation test, p=0.037).

The FP receptor genetic polymorphism may influence the degree of IOP reduction by latanoprost in these patients.

SOURCE: Sakurai M, Higashide T, Ohkubo S, et al. Association between genetic polymorphisms of the prostaglandin F2α receptor gene, and response to latanoprost in patients with glaucoma and ocular hypertension. Br J Ophthalmol. 2014;98(4):469–473.

Prevalence, Risk Factors and Health-Related Quality of Life in Dry Eye

The purpose of this cohort study was to estimate dry-eye prevalence in the Beaver Dam Offspring Study (BOSS), including a young adult population, and investigate associated risk factors and impact on health-related quality of life.

The BOSS (2005 to 2008) is a study of aging in the adult offspring of the population-based Epidemiology of Hearing Loss Study cohort. Questionnaire data on health history, medication use, risk factors, and quality of life were available for 3,275 participants. Dry eye was determined by self-report of frequency of symptoms and the intensity of those symptoms. Associations between dry eye and risk factors were analyzed using logistic regression.

It was reported that the prevalence of dry eye in the BOSS was 14.5%: 17.9% of women and 10.5% of men. In a multivariate model, statistically significant associations were found with female sex (odds ratio [OR], 1.68; 95% confidence interval [CI], 1.33 to 2.11), current contact lens use (OR, 2.01; 95% CI, 1.53 to 2.64), allergies (OR, 1.59; 95% CI, 1.22 to 2.08), arthritis (OR, 1.44; 95% CI, 1.12 to 1.85), thyroid disease (OR, 1.43; 95% CI, 1.02 to 1.99), antihistamine use (OR, 1.54; 95% CI, 1.18 to 2.02), and steroid use (OR, 1.54; 95% CI, 1.16 to 2.06). Dry eye was also associated with lower scores on the Medical Outcomes Study Short Form 36 (β=–3.9, p<0.0001) as well as on the National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25) (β=–3.4, p<0.0001) when controlling for age, sex and comorbid conditions.

In conclusion, the prevalence of dry eye and its associated risk factors in the BOSS were similar to previous studies. In this study, dry eye was associated with lower quality of life on a health-related quality-of-life instrument and the vision-specific NEI VFQ-25.

SOURCE: Paulsen AJ, Cruickshanks KJ, Fischer ME, et al. Dry eye in the Beaver Dam Offspring Study: prevalence, risk factors, and health-related quality of life. Am J Ophthalmol. 2014;157(4):799–806.

  • IND FILED FOR PHASE I/IIA CLINICAL STUDY OF CONTROLLED-RELEASE LATANOPROST INSERT FOR GLAUCOMA. BioLight Israeli Life Sciences Investments Ltd.'s wholly owned subsidiary, ViSci, has filed an Investigational New Drug (IND) application with the FDA to conduct a Phase I/IIa clinical study with its subconjunctival latanoprost controlled-release insert for the treatment of glaucoma. The three-month study in 68 glaucoma patients is designed to prove the safety and efficacy of different doses of the insert containing its proprietary form of latanoprost. Pending approval, the study will be conducted at up to seven investigative sites in the United States. Read more at
  • SPARK THERAPEUTICS AND GENABLE TECHNOLOGIES TO COLLABORATE ON A GENE THERAPY TREATMENT FOR RP. Spark Therapeutics and Genable Technologies have entered into a collaboration agreement for Genable's lead therapeutic to treat rhodopsin-linked autosomal dominant retinitis pigmentosa (RHO adRP), GT038. Under the terms of the collaboration, Genable with license certain adeno-associated virus (AAV) vector manufacturing patents from Spark. The parties have entered into a broad agreement in which Spark will be the exclusive manufacturer of the product and provide development advice and expertise to Genable to help in the ongoing development of GT038. Spark will receive milestone payments and royalties on future sales of GT038, as well as near-term revenue from the manufacture and supply of product. For more information, click here.
  • SANTEN PHASE III STUDY FOR TX OF NONINFECTIOUS POSTERIOR SEGMENT UVEITIS MEETS PRIMARY ENDPOINT. According to Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co. Ltd. the Study Assessing double-masKed Uveitis tReAtment (SAKURA) Study 1, the first of two global Phase III studies evaluating intravitreal injections of sirolimus in patients with noninfectious posterior segment uveitis (NI-PSU), met its primary endpoint. SAKURA is an ongoing multinational, multicenter, randomized, double-masked study assessing the safety and efficacy of sirolimus in which 347 patients with noninfectious posterior, intermediate or panuveitis were enrolled at approximately 150 sites. Eligible patients were randomized into three treatment arms, each receiving different doses of sirolimus by intravitreal injection. The primary endpoint was the proportion of patients achieving a vitreous haze score of zero at month five (Standardized Uveitis Nomenclature [SUN] Photographic scale). SAKURA Study 2 continues to enroll patients under the same protocol.
  • ESSILOR INTRODUCES NEW DISPENSING PLATFORM AND EXTENDED MATERIAL OPTIONS FOR DIGITAL SINGLE VISION LENSES, PLUS CONTINUED EXPANSION OF NONPROFIT ARM. Essilor of America recently introduced Visioffice 2, a dispensing platform that allows eye-care professionals to provide their patients with comprehensive vision care with a full range of accurate patient measurements, detailed and consumer-friendly patient education modules and access to exclusive Varilux lenses. The Visioffice 2 has been expanded by 18 inches to accommodate more patients and also features a new measurement option for Fitting Height Optimization to ensure natural and accurate fitting for every patient.

    The company also now offers extended material options for Essilor 360°, Essilor FIT, Essilor Azio and Essilor Eyecode Digital Single Vision lenses. In addition to previously offered material options, Essilor Digital Single Vision lenses are now available in Trexa Clear and Transitions Signature VII, Airwear Polycarbonate Transitions Vantage and Airwear Polycarbonate Transitions XTRActive.

    Finally, the Essilor Vision Foundation, the non-profit arm of Essilor of America, has launched a new website to accept online donations and provide volunteers with a simple way to sign up to help with various events across the country. The Foundation also recently kicked off service of a new mobile clinic in central Texas and continues to expand its staff.

  • NOVALIQ LAUNCHES PHASE I STUDY OF CYCLASOL EYE DROPS. Novaliq GmbH has begun a Phase I study for CyclASol (cyclosporine solution) following U.S. and European approval of the solution for the treatment of dry-eye syndrome. Unlike conventional emulsion formulas, CyclASol is a 0.05% clear cyclosporine solution that's available in multi-dose and preservative-free bottles. According to Novaliq, it has demonstrated long-term stability plus superior wettability, pharmacokinetics and biocompatibility compared to conventional emulsions.

  • IRIDEX AND SALIENT ENTER DISTRIBUTION AGREEMENT FOR CANADA. Iridex Corp. and Salient Medical Solutions have signed a distribution agreement that allows Salient to sell Iridex's full line of products, including MicroPulse laser systems, EndoProbe, GreenTip Membrane Scraper and G-Probe Glaucoma Device, throughout Canada.

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