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In 1963 the ZIP code (Zone Improvement Plan Code) was introduced ease the burden on postal workers in hand-sorting mail. Interestingly, an ad campaign had to be launched in order to encourage the public to use the zip code—just think how Don Draper of Mad Men would have created slogans like "Only you can put ZIP in your postal system." How is this relevant, you ask? Well, most of our clinical care is influenced, subtly or not so, by advertisements, and advertisements do not come only in traditional print form. We are influenced by our peers, print, lecture, internet, and other content. You may be influenced by what you read here, in Ocular Surface News.

Every other issue we present a Quick Poll to take a snapshot of a "hot topic" or controversial topic in the field. As a general disclaimer (small print), those selecting to answer the quick poll may be more passionate about the topic of the quick poll or the topic might have peaked some curiosity, thus the results may, or may not, represent the full range of clinicians reading this newsletter. In the last issue's quick poll, close to 40% of respondents reported the most common use of steroid in dry eye practice was in combination with Restasis, 15% do not use steroid in dry eye management, and 16% use steroid as first line therapy in conjunction with artificial tears. Interestingly but not surprisingly, there is a lack of quality literature about the use of topical steroids in ocular surface disease—how steroids should be used in conjunction with other therapies, how frequently monitoring for adverse events should occur (see this week's Research Update), as well as head-to-head comparisons between therapies. Yet, steroid use has a place in the overall management of a patient with ocular surface disease, with monitoring.

So, happy 50th birthday, ZIP code. What will influence our ocular surface management 50 years from now?

Kelly K. Nichols, OD, MPH, PhD

July 19, 2013
Editor's Commentary
B+L Acquires Option to License New Compound to Treat DES

Ocusoft Introduces Retaine Supplements

OphthaliX Appoints Belkin to Board of Directors

Clinician's Corner: Surgical Management of Severe Dry Eye
Research Update: Commentary on Abstract of the Week
Dry Eye 101: Medical Coding & Compliance

Results from last poll:

The topic of steroid use in ocular surface disease remains controversial. Which best describes your steroid use patterns in OSD?

1. Steroid with Restasis
2. Steroids as adjunct therapy (flare-up)
3. Steroid + artificial tears as first line therapy
4. Do not generally use steroid with OSD

B+L Acquires Option to License New Compound to Treat DES
Bausch + Lomb (B+L) and Mimetogen Pharmaceuticals Inc. announced that B+L has acquired an option to license an investigational compound currently in Phase 2 development for the treatment of dry eye syndrome (DES). The compound, called MIM-D3 and developed by Mimetogen, has the potential to be the first in a new class of agents called TrkA agonists.

Currently available dry eye therapies work to increase tear production, but do not address tear quality. MIM-D3 stimulates the production of mucin, which plays a critical role in the protection and overall health of the ocular surface. Mucins are essential for lubrication; the removal of allergens, pathogens, and debris; and corneal epithelial healing to reduce ocular surface damage. Also, according to the companies, MIM-D3 may have additional benefits than currently available dry eye therapies including the potential to improve neural function, which may improve corneal sensitivity and integrity.1

Phase 2 study results for MIM-D3 demonstrated that the use of MIM-D3, dosed twice a day, results in consistent improvements across multiple dry eye signs and symptoms with no safety or tolerability issues. A Phase 3 study is scheduled to begin before the end of 2013, which will be conducted by Ora, Inc.

If approved, the new technology would dramatically expand B+L's ability to compete in a $2.5 billion global dry eye market growing at 10 percent annually,2 while creating an opportunity to explore expanded ophthalmic applications.

Under the terms of the agreement, B+L will pay Mimetogen an upfront payment as an option fee to secure the right to acquire an exclusive global license on set terms triggered by the availability of top line results from a Phase 3 study. Should B+L choose to pursue development based on the Phase 3 results, the company will assume all development responsibilities and costs, and also will pay development milestones, sales milestones and royalty fees to Mimetogen.

Mimetogen Pharmaceuticals Inc. is a private company focused on developing the use of peptidomimetics as a novel approach to treating ophthalmic diseases with high unmet medical needs. The underlying technology was developed at McGill University and the Lady Davis Institute for Medical Research in Montreal. The company is currently developing novel therapeutic approaches for indications including dry eye disease, glaucoma and degenerative diseases of the retina.

1. Joo MJ et al. The Effect of Nerve Growth Factor on Corneal Sensitivity After Laser in Situ Keratomileusis. Arch Ophthalmology. 2004 Sep; 122(9): 1338-41
2. IMS MIDAS (MAT Q1 2013)

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Ocusoft Introduces Retaine Supplements
Ocusoft, Inc. announced the availability of two new dietary supplements specially formulated to support ocular health, Retaine OM3 and Retaine FLAX. Retaine supplements contain a unique blend of Omega-3 and Omega-6 Essential Fatty Acids, which have been reported to reduce inflammation associated with dry eye. Retaine OM3 contains high potency EPA and DHA, 800 mg and 400 mg per serving respectively, while Retaine FLAX contains flax seed oil making it ideal for individuals who cannot tolerate fish oil-based supplements.

Both supplements are conveniently packaged in blister cards to improve compliance and reduce the potential for missed doses. Retaine OM3 contains 60 softgel capsules, two taken daily and Retaine FLAX contains 120 softgel capsules, four to be taken daily or as directed by a health care professional.

Retaine OM3 and Retaine FLAX join a growing line of Retaine brand eye care products, including artificial tears, exclusively available through eyecare professionals. Introductory discount pricing is available to practitioners dispensing from their office, however, patients may also order online directly at www.ocusoft.com/retaine.

For more information, call (800) 233-5469 or visit www.ocusoft.com.

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OphthaliX Appoints Belkin to Board of Directors
OphthaliX, Inc. has appointed Dr. Michael Belkin to the Company's Board of Directors. Dr. Belkin is a Professor of Ophthalmology at Tel Aviv University in Tel Aviv, Israel, and the Director of the Ophthalmic Technologies Laboratory at the university's Eye Research Institute at the Sheba Medical Center. He was awarded a master's degree in natural sciences by Cambridge University, England, and received a doctorate in medicine from the Hebrew University of Jerusalem. Dr. Belkin served previously as Director of Research, Development and Non-Conventional Warfare Medicine in the Israel Defense Forces Medical Corps. He was also the first full-time Director of the Tel Aviv University Eye Research Institute, Chairman of the Tel-Aviv University Department of Ophthalmology and the President of the Israel Society of Eye and Vision Research, of which he was one of the founders.

Dr. Belkin is an author of over 250 scientific publications and 20 patents. He is an internationally recognized eye researcher and has received various research awards. He is an entrepreneur and advisor of several ophthalmic companies in the fields of lasers, optics, ophthalmic devices, pharmaceutics and biotechnology.

OphthaliX Inc. is a clinical-stage biopharmaceutical company focused on developing therapeutic products for the treatment of ophthalmic disorders. OphthaliX's product candidate, CF101, an A3 adenosine receptor agonist, is a novel, first in class, small molecule, orally bioavailable drug which demonstrated efficacy and an excellent safety profile in Phase 2 clinical studies. CF101 is currently developed for ophthalmic indications, including dry eye syndrome (Phase 3), glaucoma (Phase 2) and uveitis.

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Victor Perez, MD

The Use of the Modified Osteo-Odonto Keratoprosthesis for the Treatment Corneal Blindness in Patients with End-Stage Dry Eye

The notion of using the "eye tooth" to rehabilitate the vision of blind patients with scarring of the cornea due to severe dry eye may sound bizarre. However, the Modified Osteo-Odonto-Keratoprosthesis (MOOKP) for the treatment of corneal blindness in patients with end-stage dry eye keratinized ocular surface is considered the standard of care worldwide and has the most successful and longest follow-up reported data.1-5 The most common conditions that lead to this type of severe end-stage dry eye condition are inflammatory processes such as Stevens Johnson Syndrome, Ocular Cicatricial Pemphigoid, severe Dry Dye Syndrome and chemical / thermal burns. The rehabilitation of vision in these patients is a frustrating task because no limbal stem cell or corneal transplant can survive in a desiccated environment.

The MOOKP procedure changes the dry ocular surface into a site where bio-integration of a PMMA optical cylinder, a tooth and the cornea is possible. The MOOKP is performed in three stages: stage 1, intraocular preparation of the eye (lensectomy, iris removal and vitrectomy) and extraction of the canine tooth for the manual preparation of the osteo-odonto lamina (keratoprosthesis) based on the axial length; stage 2, the ocular surface is covered with an oral buccal mucosa graft; and final stage 3, the osteo-odonto keratoprosthesis is placed in the eye.6-7 We have learned that the MOOKP can restore functional vision and can drastically change quality of life.

In the United States a systematic approach has been developed where a multi-disciplinary collaborative team between ophthalmology and maxillo-facial surgery that works together to perform this procedure and achieve equivalent outcomes.8-9 In addition, to provide this surgical therapy to our patients, we are learning from the tooth and the oral buccal mucosa interaction in the MOOKP, new biological pathways that will allow us to think "outside the box" to create a novel keratoprosthesis that will survive without having to give a tooth for an eye.

1. Falcinelli G FB, Taloni M, Colliardo P, Falcinelli G. Modified osteo-odonto-keratoprosthesis for treatment of corneal blindness: long-term anatomical and functional outcomes in 181 cases. Arch Ophthalmol. 2005;123:1319-29.
2. Liu C OS, Tandon R, Herold J, Hull C, Thorp S. Visual rehabilitation in end-stage inflammatory ocular surface disease with the osteo-odonto- keratoprosthesis: results from the UK. Br J Ophthalmol. 2008;92:1211-7.
3. Liu C PS. Independent survey of long term results of the Falcinelli osteo-odonto-keratoprosthesis (OOKP). An Inst Barraquer. 1999;28(S):91-3.
4. Sciscio A HJ, Hull C, Liu C. Early British results of osteo-odonto-keratoprosthesis. An Inst Barraquer. 2001;30:59-63.
5. Tan DT TA, Theng JT et al. Keratoprosthesis surgery for end-stage corneal blindness in Asian eyes. Ophthalmology 2008;115:503-10.
6. Hille K GG, Liu C et al. Standards for modified osteo-odonto-keratoprosthesis (OOKP) surgery according to Strampelli and Falcinelli: the Rome- Vienna Protocol. Cornea 2005;24:895-908.
7. Falcinelli GC BG, Caselli M, Colliardo P, Taloni M. Personal changes and innovations in Strampelli's osteo-odontokeratoprosthesis. An Inst Barraquer 1999;28(S):47-8.
8. Sawatari Y, Perez VL, Parel JM, Alfonso E, Falcinelli G, Falcinelli J, Marx RE. Oral and maxillofacial surgeons' role in the first successful modified osteo-odonto-keratoprosthesis performed in the United States. J Oral Maxillofac Surg. 2011 Jun;69(6):1750-6.
9. Sawatari Y, Marx RE, Perez VL, Parel JM. The Biointegration of the Osteo-Odonto Lamina in the Modified Osteo-Odonto Keratoprosthesis: Tissue Engineered to Return Lost Vision. Oral Craniofac Tissue Eng 2011;1:112-117.

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Blair Lonsberry, MS, OD, MEd., FAAO

Topical corticosteroids are frequently used in the treatment of ocular inflammation. A known complication to their use is a potential IOP increase. Loteprednol etabonate 0.5% (Lotemax; Bausch + Lomb, Inc., Rochester, NY) is a topical ocular anti-inflammatory corticosteroid that has a reduced incidence of increased IOP as compared to dexamethasone.

The authors of this week's featured study carried out a retrospective chart review and characterized the timing and severity of IOP elevations in patients who were prescribed loteprednol etabonate or loteprednol etabonate/tobramycin in tertiary care clinics to treat a variety of ocular surface and postoperative conditions. Manual chart review of five clinics was carried out, and any patient who had an IOP increase >5 mm Hg was included. A variety of demographic and medical history was recorded for each patient. Dry eye (30%), postoperative treatment (22%), and treatment of allergic conjunctivitis (10%) were the most common reasons for receiving loteprednol etabonate. The median duration of treatment at the time of observed IOP elevation was 55 days with a mean increase in IOP of 9.2 mm Hg. Known previous steroid responders had an increased IOP rise with a mean of 15.3 mm Hg. Within this study group, 24% of patients required ocular hypotensive medications during treatment (14% patients received one medication and 10% received two medications) and 8% patients required glaucoma surgery (including shunt, SLT and cyclodrestructive procedures).

In this study, only charts of patients with IOP increases were reviewed, thus the lack of IOP responder incidence data when using loteprednol etabonate can be considered a limitation of the study. The authors conclude that the risk of IOP elevations is lower with loteprednol etabonate than with older ketone based corticosteroid products; however, even the newer, ester-based corticosteroid products can induce IOP elevations within a short time frame and require IOP monitoring. Alternatives to corticosteroids should be considered when long-term treatment is required for an ocular surface condition.

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Intraocular Pressure Elevations with Loteprednol Etabonate: A Retrospective Chart Review
Rajpal RK, Digby D, D'Aversa G, Mah F, Hollander DA, Conway T. J Ocul Pharmacol Ther. 2011 Jun;27(3):305-8. doi: 10.1089/jop.2010.0182. Epub 2011 May 16. See Clearly Vision, McLean, Virginia 22102, USA.

PURPOSE: Ocular corticosteroids can cause elevations in intraocular pressure (IOP). The purpose of this study was to characterize the timing and severity of IOP elevations in patients receiving loteprednol etabonate 0.5% or loteprednol etabonate 0.5%/tobramycin 0.3%.

METHODS: A retrospective chart review was conducted at five academic and private practices. Any patient who experienced an elevation in IOP ≥5 mm Hg while using loteprednol etabonate or loteprednol etabonate/tobramycin was eligible for inclusion in the study. Data collected included patient demographics, medical and ophthalmic history, concomitant medications, reason for treatment, IOP, and medical and surgical interventions.

RESULTS: Fifty patients experienced IOP elevations after use of topical loteprednol etabonate and were included in the study. The mean (standard deviation [SD]) patient age was 58.8 (20.3) years and 66% were women. The most common reasons for prescribing loteprednol etabonate were dry eye (30%), postoperative therapy (22%), and allergic conjunctivitis (16%). Before treatment, 28% of patients had a history of open-angle glaucoma or ocular hypertension. Mean (SD) IOP before treatment was 15.5 (3.2) mm Hg and increased to a mean (SD) of 24.7 (6.5) mm Hg, a statistically significant increase of 9.2 (SD: 5.8; range: 5-29) mm Hg (P<0.0001). The median duration of treatment with loteprednol etabonate at the time of observed IOP elevation was 55 days (range: 3 days to 3 years). Twenty-four percent of patients required IOP-lowering medications and 8% required surgery to control the elevated IOP.

CONCLUSIONS: Alternatives to corticosteroids should be considered when long-term treatment is required for an ocular surface condition.

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DRY EYE 101:

John Rumpakis, OD, MBA

Question: I have been expressing the meibomian glands therapeutically in office. Is there a procedure code for that or can I charge out of pocket for the therapy?

Answer: Since MGD has gained popularity as a clinical entity in OD's offices, this is a question that I get asked quite frequently. Unfortunately, there is no CPT code that represents the specific procedure of meibomian gland expression. I have seen people that are misrepresenting expression of the meibomian glands as a surgical procedure, which it clearly is not, or try to raise the level of office visit to the next level because of the time spent – also inappropriate.

Currently, the best way to "code" for this is to simply use either a 92002 (if you meet the definition) or an appropriate 992XX code which represents the level of history, physical exam and medical decision making actually performed. In most cases it would be a 99201 or 99212 because of the limited nature of the presenting problem. While I understand that many may be disappointed with the limited reimbursement associated with this, disappointment is not a reason to put yourself at risk by misrepresenting what you are actually doing or raising the level of complexity above the actual recorded encounter.

There is a HCPCS Level III code that was established a few years back for the Lipiflow procedure by TearScience, 0207T, which is defined as "Evacuation of meibomian glands, automated, using heat and intermittent pressure, unilateral" so this code does not cover probing or manual expression of the glands. In most cases a HCPCS Level III code is payable by the patient, even though you will have to submit the claim to the insurer just so they can track utilization of the procedure.

While expression or probing of the meibomian glands may prove clinically beneficial for the patient, there is currently no method within the CPT to provide additional compensation to the practitioner for the additional time spent in providing this care to the patient.

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