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Valeant Completes Acquisition of B+L
Valeant Pharmaceuticals International, Inc. completed its acquisition of Bausch + Lomb (B+L) on August 5, 2013. Bausch + Lomb will retain its name and become a division of Valeant. Valeant's existing ophthalmology businesses will be integrated into the B+L division, creating a global eye health platform with estimated pro forma 2013 net revenue of more than $3.5 billion. The united business has a vast eyecare product portfolio and an array of late stage over-the-counter, prescription and ophthalmic surgery products in the development pipeline.
In a separate release from Valeant on its second quarter results, the company noted that to finance the transaction and add to their liquidity, Valeant raised $9.6 billion by issuing 27.1 million common shares, $3.2 billion in senior unsecured notes and $4.1 billion in senior secured credit facilities. Valeant expects to realize significantly more than $800 million of cost synergies from the combined company, with a run rate north of $500 million by year-end 2013 and a run rate significantly more than $800 million by year-end 2014.
Upon the completion of the acquisition, Valeant began to implement its previously announced plans to downsize the combined company global workforce by up to 15% (potentially almost 2,900 positions worldwide) by announcing the immediate layoff of 200 employees in the Rochester B+L facilities. According to information released by New York Gov. Andrew Cuomo's office, Valeant plans to cut an additional 200 B+L employees by early 2014. Valeant also plans to locate the new B+L division headquarters somewhere in New Jersey.
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CLINICIAN'S CORNER:
MANAGEMENT OF SEVERE DRY EYE
Victor Perez, MD
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Dry Eyes and Menopause: But Don't Forget Men
How many of us encounter in our clinical practice the chief complaint and clinical presentation of "I have dry eye" and "it started getting worst after menopause"? In fact, this is not surprising, as the incidence of keratoconjunctivitis sicca is 2-4 times higher in women than in men especially around the menopause age. This indicates that hormonal changes that accompany menopause may play a role in the pathogenesis of dry eye disease.1
Women with premature ovarian failure exhibit more dry eye symptoms than age-matched controls2 and patients with Sjogren's syndrome also have low plasma androgens, which are thought to result in decreased tear secretion and increased inflammation.1,3 Studies have shown that androgen deficiency results in meibomian gland dysfunction and evaporative dry eye.4,5 Thus, androgen and estrogens treatments are considered as alternate clinical therapies—and we are starting to see clinical research in this area. In one case report, topical androgen therapy improved the tear lipid layer.6 In a randomized control study, estrogen eye drops improved subjective symptoms of dry eyes and tear production in menopausal women.7
Controversy exists over the effects of hormone replacement therapy (HRT) on dry eye syndrome with some studies showing improvement of dry eye, others worsening, and another with no effect of using HRT.8 Interesting, we should not forget that older men also get dry eye. Our studies in older veteran men at the United States Veteran Affairs Hospital demonstrate that aged men also have significant symptoms of dry eye; however, the tempo of onset is longer compared to the female population.9 This raises the question regarding which hormonal changes are significant in our male patients or where there is another etiology for the causes of dry eye syndrome in men. Therefore, as clinicians we need to be very aware of the correlation between dryness and menopause in our female patients, while not forgetting our male patients. More studies are needed to elucidate the relationship between dry eye and local and systemic hormonal changes associated with dry eye in order to find new modalities of treatment.
Acknowledgement: This column was prepared by Zaina Al-Mohtaseb, MD, Anat Galor, MD and Victor L Perez, MD.
References
1. Versura P, Campos EC. Menopause and dry eye. A possible relationship. Gynecol Endocrinol. 2005 May;20(5):289-98.
2. Smith JA, Vitale S, Reed GF, Grieshaber SA, Goodman LA, Vanderhoof VH, Calis KA, Nelson LM. Dry eye signs and symptoms in women with premature ovarian failure. Arch Ophthalmol. 2004;122:151-6.
3. Suzuki T, Schaumberg DA, Sullivan BD, Liu M, Richards SM, Sullivan RM, Dana MR, Sullivan DA. Do estrogen and progesterone play a role in the dry eye of Sjogren's syndrome? Ann N Y Acad Sci. 2002;966:223-5.
4. Sullivan DA, Sullivan BD, Evans JE, Schirra F, Yamagami H, Liu M, Richards SM, Suzuki T, Schaumberg DA, Sullivan RM, et al. Androgen deficiency, Meibomian gland dysfunction, and evaporative dry eye. Ann N Y Acad Sci. 2002;966:211-22.
5. Khandelwal P, Liu S, Sullivan DA. Androgen regulation of gene expression in human meibomian gland and conjunctival epithelial cells. Mol Vis. 2012;18:1055-67. Epub 2012 Apr 27.
6. Worda C, Nepp J, Huber JC, Sator MO. Treatment of keratoconjunctivitis sicca with topical androgen. Maturitas. 2001;37:209-12
7. Sator MO, Joura EA, Golaszewski T, Gruber D, Frigo P, Metka M, Hommer A, Huber JC. Treatment of menopausal keratoconjunctivitis sicca with topical oestradiol. Br J Obstetr Gynaecol. 1998;105:100-2.
8. Schaumberg DA, Buring JE, Sullivan DA, Dana MR. Hormone replacement therapy and dry eye syndrome. J Am Med Assoc. 2001;286:2114-19.
9. Galor A, Feuer W, Lee DJ, Florez H, Venincasa VD, Perez VL. Ocular surface parameters in older male veterans. Invest Ophthalmol Vis Sci. 2013 Feb 19;54(2):1426-33.
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RESEARCH UPDATE:
COMMENTARY ON ABSTRACT OF THE WEEK
Blair Lonsberry, MS, OD, MEd., FAAO
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Ocular surface inflammation is known to contribute to ocular surface disease. Gamma-linolenic acid (GLA) and omega-3 polyunsaturated fatty acids (PUFAs) have been found to decrease the production of inflammatory mediators that are linked to the development of chronic dry eye. The purpose of this study was to evaluate the effect of a supplement containing both GLA and n-3 PUFAs on signs and symptoms of moderate-to-severe keratoconjunctivitis sicca in postmenopausal patients.
This study was a multicenter, double-masked placebo-controlled clinical trial with tear dysfunction patients randomized to supplemental GLA + n-3 PUFAs or placebo for 6 months. The supplement is a proprietary blend of Omega-3 and Omega-6 fatty acids, vitamins and minerals. Four softgels were taken daily. Disease parameters included: OSDI, Schirmer test, TBUT, conjunctival fluorescein and lissamine green staining, and topographic corneal smoothness indexes, and were assessed at baseline and at 4, 12, and 24 weeks. Dendritic cell CD11c integrin and HLA-DR expression were also measured with conjunctival impression cytology (increased levels of these markers have been linked to chronic dry eye).
OSDI score improved and both OSDI and surface asymmetry index with supplementation and were significantly lower than placebo after 24 weeks. The placebo treatment group demonstrated significantly greater HLA-DR intensity and CD11c when compared with the supplement treatment group. Neither treatment had any effect on tear production, tear breakup time, or corneal/conjunctival staining. The results of this study indicate that nutritional supplementation with GLA (source was black currant seed oil) and fish oil (PUFAs) should be considered in the treatment of patients suffering from tear dysfunction to help alleviate symptoms of irritation, prevent exacerbations in ocular surface inflammation and corneal epithelial disease.
Limitations of the study include the effects of individual nutrients were not separately evaluated and patient compliance was obtained by counting the number of pills dispensed and returned. Improved symptoms in the absence of improvement in clinical signs, but with positive changes in biomarkers, poses a problem in monitoring treatment effects. In the clinical setting, accurately assessing symptomatic change can be difficult, unless the change is clinically meaningful to the patient.
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Long-term Supplementation with n-6 and n-3 PUFAs Improves Moderate-to-Severe Keratoconjunctivitis Sicca: A Randomized Double-Blind Clinical Trial
Sheppard JD Jr, Singh R, McClellan AJ, Weikert MP, Scoper SV, Joly TJ, Whitley WO, Kakkar E, Pflugfelder SC. Cornea. 2013 Jul 23. [Epub ahead of print]
PURPOSE: Supplementation with gamma-linolenic acid (GLA) and omega-3 (n-3) polyunsaturated fatty acids (PUFAs) has been found to decrease the production of disease-relevant inflammatory mediators that are implicated in the pathogenesis of chronic dry eye. This study evaluated the effect of a supplement containing both GLA and n-3 PUFAs on signs and symptoms of moderate-to-severe keratoconjunctivitis sicca in postmenopausal patients.
METHODS: This multicenter, double-masked placebo-controlled clinical trial enrolled 38 patients (both eyes) with tear dysfunction who were randomized to supplemental GLA + n-3 PUFAs or placebo for 6 months. Disease parameters, including Ocular Surface Disease Index, Schirmer test, tear breakup time, conjunctival fluorescein and lissamine green staining, and topographic corneal smoothness indexes (surface asymmetry index and surface regularity index), were assessed at baseline and at 4, 12, and 24 weeks. The intensity of dendritic cell CD11c integrin and HLA-DR expression was measured in conjunctival impression cytologies.
RESULTS: The Ocular Surface Disease Index score improved with supplementation and was significantly lower than placebo (21 ± 4 vs. 34 ± 5) after 24 weeks (P = 0.05, n = 19 per group). The surface asymmetry index was significantly lower in supplement-treated subjects (0.37 ± 0.03, n = 15) than placebo (0.51 ± 0.03, n = 16) at 24 weeks (P = 0.005). Placebo treatment also significantly increased HLA-DR intensity by 36% ± 9% and CD11c by 34% ± 7% when compared with supplement treatment (n = 19 per group, P = 0.001, 24 weeks). Neither treatment had any effect on tear production, tear breakup time, or corneal or conjunctival staining.
CONCLUSIONS: Supplemental GLA and n-3 PUFAs for 6 months improved ocular irritation symptoms, maintained corneal surface smoothness, and inhibited conjunctival dendritic cell maturation in patients with postmenopausal keratoconjunctivitis sicca.
Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00883649.
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DRY EYE 101:
MEDICAL CODING & COMPLIANCE
John Rumpakis, OD, MBA
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Question: I just bought a Oculus Keratograph 5 for the "tear film suite" and meibography...can I get paid for that?
Answer: According to the Oculus website (http://www.oculus.de/en/sites/detail_ger.php?page=610, last accessed 8/1/2013), Oculus states the following:
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The Keratograph 5M - More than a topographer!
The new Keratograph 5M technology is a revolution in corneal topography and Dry Eye analysis. The high-resolution color camera and the integrated magnification changer offer a new perspective to the tear film assessment procedure.
- Corneal Topography
- Real Keratometry
- Meibography
- Tear Film Assessment (NIKBUT and Tear Meniscus Height measurement)
- Color Photos and Videos
- Keratoconus Detection
- Contact Lens Fitting
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While technology continues to advance to assist us in providing clinical care to our patients, it is not always a method of generating additional income through the billing of new procedures or tests. If I look at the bulleted list of functions this instrument provides, the only separately billable procedures are corneal topography (CPT 92025) and color photos (92285). While other valuable information is provided by this technology, it is not separately billable outside of the office visit itself. So any assessments of the tear film, or meibomian gland structure, keratoconic detection, etc., are simply components contained in the definition of either the 920XX or 992XX codes.
Also realize that since 92025 and 92285 are both special ophthalmological procedures, you must meet the requirements for medical necessity in the medical record and complete an Interpretation and Report properly to complete these services.
Technology adds a lot to the patient care that we deliver on a daily basis, providing better data to augment our clinical skills, however it doesn't necessarily add additional billable services to increase revenue for the practice. Always be sure to do your due diligence independently to make sure you are aware of the rules as you evaluate adding any technology to your practice.
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