Volume 9, Number 13
Monday, April 6, 2009



In this issue: (click heading to view article)
From the Editor: Medical Care Versus Health Care
Monitoring Treatment Progress with Anterior Segment OCT
Glitazone Use and Diabetic Macular Edema
Interferon Alpha Treatment for Chronic CME
Briefly





When your PGA patients need a change







From the Editor: Medical Care Versus Health Care


One of the great things about living in Southwest Florida is that I get to go to the beach whenever I want. Recently, I was enjoying a sunny day at the beach and, as it turned out, it was Spring break. Needless to say, there were scores of teens and what really struck me was the number of them that smoked. Maybe someone could actually quote a statistic that indicates that less teens smoke today than in previous generations, but why does this still continue, given the potential health risks?

This observation brought me back to a book I am reading, “Applied Economics,” by Thomas Sowell. This book looks at the long-term economic impact of previous and potential future political decisions, both domestic and international. Sowell has an interesting chapter on the economics of health care in which he makes a distinction between medical care and health care. Essentially, and in his view, medical care is what we physicians provide to patients who have medical or surgical diseases in an effort to make them healthy. Health care is more so a practice whereby risk factors for future health disease (such as smoking) are identified and recommendations are made or steps implemented to overt or minimize heath risks for an individual in the future.

Sowell goes on to say that governmental provision of medical care is politically expedient and possesses mass appeal, but it provides minimal if any foundation to improve the health of any nation or minimize the financial burdens of a society in the long run. Let's face it, preventative medicine is not that sexy, but can be very effective over time. I think it is time for this nation to have an honest discussion about addressing the uninsured as well as the inevitable financial burden that will come when Baby Boomers age. Part of the plan should be a program for minimization of health risks. This will require politicians to look beyond the next election and actually do the right thing for generations to come. Physicians must join the discussion in order to educate politicians and citizens in general about the potential long-term impact of their myopic decisions.

Stephen Pascucci, MD, FACS
















Monitoring Treatment Progress with Anterior Segment OCT

This Polish study evaluated the usefulness of anterior segment optical coherence tomography (AS OCT) for initial diagnosis and monitoring treatment results in eye injury cases. A total of 38 eyes of 34 patients (mean age = 33.8 years) with different types of ocular injuries (penetrating injury [8 eyes], perforating injury [2 eyes], intraocular foreign body [4 eyes], ocular burn [9 eyes], contusion [13 eyes] and lamellar laceration [2 eyes]) were examined and AS OCT examination was performed at the initial visit, directly after injury and repeated as treatment progressed. Both anterior chamber components and corneal pachymetry were evaluated.

Slit lamp exam did not provide a clear diagnosis in three eyes after contusion because of a nontransparent cornea. In one case of a 44-year-old male patient, only corneal edema was noticed during slit lamp exam, whereas AS OCT revealed Descemet's membrane detachment. And in a 17-year-old male patient with blood infiltrating the cornea, OCT revealed acute angle closure with a pupillary block. OCT was valuable for monitoring the corneal healing progress after amniotic membrane application in patients with corneal burns and was also useful for determining whether a lamellar or penetrating technique should be applied in patients who qualified for corneal transplantation. Additionally, AS OCT was helpful in establishing the localization and size of foreign bodies in patients with foreign bodies.

AS OCT was determined to be a very valuable tool for early diagnosis and monitoring treatment progress in ophthalmic departments dealing with ocular trauma.

SOURCE: Wylegala E, Dobrowolski D, Nowinska A, Tarnawska D. Anterior segment optical coherence tomography in eye injuries. Graefes Arch Clin Exper Ophthalmol 2009; 247(4):451-455.






http://www.restasisprofessional.com/








Glitazone Use and Diabetic Macular Edema

To determine the ocular safety of glitazones (a class of oral hypoglycemics) in diabetic patients, researchers conducted a prospective cohort study to investigate the association of diabetic macular edema (DME) in a large population of glitazone users.

They identified approximately 170,000 patients with diabetes using the Diabetes Case Identification Database and obtained information on glitazone drug use from the pharmacy database. The main outcome measure was the development of macular edema (ME). The researchers used the x2 test to compare proportions and t tests for means. Additionally, they used logistic regression analysis to adjust for potential confounding variables.

A total of 996 new cases of ME cropped up in 2006 and the researchers found that glitazone users were more likely to develop ME in 2006 (odds ratio [OR], 2.6; 95% confidence interval [CI], 2.4 to 3.0). After excluding patients who did not have the drug benefit, did not have an eye exam and had an HgA1c <7.0, glitazone use was still associated with an increased risk of developing ME (OR, 1.6; 95% CI, 1.4 to 1.8).

According to the researchers, their study appears to show that the glitazone class of drug is associated with DME and that, even after adjusting for confounding factors of age, glycemic control and insulin use, glitazones are still modestly associated with DME. A more in-depth study is needed to evaluate the role of other confounding factors. The researchers advise that when treating DME patients, ophthalmologists consider the role of the glitazones.


SOURCE: Fong DS, Contreras R. Glitazone use associated with diabetic macular edema. Am J Ophthalmol 2009;147(4):583-586.






Interferon Alpha Treatment for Chronic CME

In a retrospective analysis of an interventional case series, the authors aimed to assess the efficacy and tolerability of interferon (IFN) alpha in chronic cystoid macular edema (CME) due to non-infectious uveitis. They found that their data demonstrate IFN alpha to be an effective and well-tolerated therapy for chronic refractory uveitic CME.

IFN alpha-2a was administered at an initial dose of 3 or 6 million IU per day subcutaneously and tapered afterwards to the lowest possible dose to maintain the absence of CME. Efficacy of treatment was assessed using optical coherence tomography.

A total of 24 patients with chronic CME (median duration 36.0 months) due to noninfectious anterior (n=2), intermediate (n=18) or posterior (n=4) uveitis have been analyzed. According to the authors, ineffective pre-treatment included systemic corticosteroids (all patients), acetazolamide (22 patients) and at least one immunosuppressive drug (18 patients). IFN therapy was shown to be effective (= complete resolution of CME within 3 months, able to taper IFN) in 15 patients (62.5%), partly effective (= incomplete resolution of CME, unable to taper IFN) in 6 patients (25.0%) and not effective (= no response or recurrence of CME) in 3 patients (12.5%).

The study authors concluded that IFN treatment was generally well tolerated. Common side effects, including flu-like symptoms; fatigue or increased liver enzymes, were dose-dependent and led to discontinuation of IFN in only 1 patient.

SOURCE: Deuter CME, Kötter I, Günaydin I, et al. Efficacy and tolerability of interferon alpha treatment in patients with chronic cystoid macular edema due to non-infectious uveitis. Br J Ophthalmol 2009; Mar 24 [Epub ahead of print].




  • POSITIVE RESULTS FOR LUMINATE PHASE 3 PROGRAM OF LUVENIQ. Lux Biosciences, Inc. recently announced the results from the three phase 3 Luminate trials of its LX211 (Luveniq, voclosporin oral capsule) drug candidate for the treatment of uveitis. The three randomized, double-masked, dose-ranging and placebo-controlled trials comprising the Luminate Program enrolled 558 patients at 56 sites in 7 countries (United States, Canada, United Kingdom, France, Germany, Austria and India). The trials included 218 patients with active non-infectious uveitis with posterior manifestation of the disease (LX211-01), 232 patients with clinically quiescent disease (LX211-02) and 108 patients with active uveitis with anterior manifestation of the disease (LX211-03). According to the company, the data show a positive effect on ocular inflammation and a safety profile consistent with the expected use of LX211 in this indication. Read more about the trial results here.
  • FDA PANEL RECOMMENDS APPROVAL OF PMA FOR IMPLANTABLE TELESCOPE. According to VisionCare Ophthalmic Technologies, Inc., the FDA Ophthalmic Devices Advisory Panel has unanimously recommended that the FDA approve, with conditions such as post-approval surveillance and labeling suggestions, the premarket application (PMA) for its implantable telescope for end-stage AMD. Smaller than a pea, the investigational Implantable Miniature Telescope is designed to be a solution for moderate to profound vision loss due to advanced, end-stage forms of AMD that have no current surgical or medical treatment options. VisionCare Ophthalmic Technologies, Inc. explains that the prosthetic device is implanted during an outpatient surgical procedure in one eye, where it renders enlarged central vision images over a wide area of the retina to improve central vision, while the non-operated eye provides peripheral vision for mobility and orientation.
  • SARCODE ANNOUNCES RESULTS AND PLANS FOR SAR 118. SARcode Corporation recently announced the results of its Phase 1 randomized, double-masked, placebo-controlled trial of the safety, tolerability and pharmacokinetics of single- and multiple-escalating doses of SAR 1118 Ophthalmic Solution in healthy adult subjects. The trial was designed to evaluate the local and systemic safety and pharmacokinetic parameters of SAR 1118 Ophthalmic Solution in the plasma and tear of 28 healthy adults at four dose strengths (0.1, 0.3, 1.0 and 5.0%). SAR 118 was well tolerated and demonstrated a favorable safety profile when administered by topical ocular instillation up to three times daily at dose strengths of up to 5%. Furthermore, the pharmacokinetic parameters demonstrated adequate ocular exposure at all three dose schedules with minimal systemic exposure. Based on the results of the trial, SARcode has selected dose strengths and schedules for its Phase 2 programs in allergic conjunctivitis and dry eye. Data for these programs is expected in 2009. For additional information, visit the company"s website.