Jasek obtained his PhD in Medical Sciences (Pharmacology & Toxicology) at Texas A&M University Health Science Center and was a Postdoctoral Fellow at California Institute of Technology prior to entering industry in 1997. Fifteen years of his time in industry have been in the ophthalmic pharmaceutical and device space with positions spanning clinical affairs, medical affairs, technical sales training, and product management while at Allergan and Alcon. Previous leadership positions held include Senior Product Manager (Surgical Glaucoma) and Director, Global Medical Affairs (Glaucoma, Allergy and Glaucoma Surgery) at Alcon.

EBI-005, a topical IL-1 receptor antagonist for the treatment of ocular surface disease, is currently being evaluated in a pivotal Phase 3 clinical study in subjects with dry eye disease and a Phase 2 clinical study in subjects with allergic conjunctivitis. EBI-029, an IL-6 receptor antagonist for localized intravitreal treatment of back of eye disease, is currently in preclinical development for the treatment of diabetic macular edema.

• (Program #1062, Poster #B0200): Sunday, May 4, 2014, 3:15 p.m. to 5:00 p.m. ET, “Optimized IL-6 Blockade for the Treatment of Diabetic Macular Edema,” Mike Schmidt, Eleven Biotherapeutics, Poster Session #158, The Diabetic Retina: physiology and pharmacology.
• (Program #3672, Poster #A0186): Tuesday, May 6, 2014, 3:45-5:30 p.m. ET, “Reduced Rescue Artificial Tear Use in Subjects Using a Topical Interleukin-1 (IL-1) Receptor-1 (R1) Blocker for Ocular Treatment of Dry Eye Disease (DED),” Michael H. Goldstein, Eleven Biotherapeutics, Poster Session 376, Dry Eye Disease #2.
• (Program #3686, Poster #A0200): Tuesday, May 6, 2014, 3:45-5:30 p.m. ET, “Topical Interleukin-1 (IL-1) Receptor Inhibition Reduces Ocular Pain,” Eric S. Furfine, Eleven Biotherapeutics, Poster Session #376, Dry Eye Disease #2

Eleven Biotherapeutics’ most advanced product candidate is EBI-005, which was designed, engineered and generated using the Company’s AMP-Rx platform and is being developed as a topical treatment for dry eye disease and allergic conjunctivitis. In 2013, Eleven Biotherapeutics completed a Phase 1b/2a clinical trial of EBI-005 in patients with moderate to severe dry eye disease. The EBI-005 program is based on the role that elevated levels of the inflammatory cytokine interleukin-1, or IL-1, play in the initiation and maintenance of the inflammation and pain associated with dry eye disease and the redness and itching associated with allergic conjunctivitis.

In particular, the portfolio includes two artificial tear formulations, Eyestil and Lacrisifi, developed to treat dry eye conditions resulting from altered or reduced tear production. Additionally, Colbiocin, Nettavisc and Nettacin offer three antibiotic options, available in multiple dosage forms, for the treatment of external eye infections. Prenacid is a water-soluble corticosteroid indicated for treatment of inflammations, including post-surgical inflammations, and allergies. Octilia is an eye drop solution indicated for treatment of irritations, reddening, ocular congestion and pruritus due to allergic, chemical or physical causes. Lastly, Mirtilene Forte is a retinotrophic with a vasoprotective action helpful in cases of capillary fragility or vascular alterations due to diabetic retinopathy.

All the drugs have undergone clinical studies and are registered in Russia and the European Union. NovaMedica plans to initiate sales of some of these products in Russia later this year.

For more details visit www.novamedica.com and www.sifigroup.com.

In my practice, I do attempt to be proactive. Hopefully it doesn’t fall on deaf ears, but at least I know I am trying. I don’t know how many times I’ve informed someone with severe dry eye due to stage 3 or 4 meibomian gland dysfunction (MGD) that their condition has likely taken many years to develop, and their responses are always similar: “But I go to the eye doctor every year like I’m supposed to and they’ve never said anything!” We may not have data to tell us undeniably that early intervention will prevent or reduce the severity of MGD, however, I’m not willing to wait for it. Heat therapy has been the mainstay for MGD and studies have shown that lipid layer thickness is improved by both warm compresses andLipiflow (TearScience, Inc.), an automated system that provides simultaneous heat and lid massage.^1-3

Compliance with warm compress therapy is likely not very good. Perhaps this is partly because of how we ask patients to do them. Some of us ask for 5-10 minutes using a washcloth that will lose its heat in 30 seconds while others recommend food products such as hard-boiled eggs, rice and potatoes which might leave our patients questioning our sanity.

Recently, we started recommending the Bruder Eye Hydrating Compress with MediBeads (Bruder Healthcare Co., Alpharetta, GA) in our Dry Eye Center. The reusable mask is microwaved for 20-30 seconds which provides heat for a 3-5 minute interval. We sell it in our office and also show patients where to purchase it on-line if they prefer. Since recommending the Bruder mask, we have certainly seen improved compliance with warm compress therapy. It could be that we are inadvertently spending more time on patient education because we have a physical product to discuss, or it may be that we are finally recommending a “professional” device for warm compress therapy and patients are taking us more seriously. It may also be that patients are simply more likely to use something they have spent money on. Whatever the reason, it seems to be working.

1. Olson MC, Korb, DR, Greiner JV. Increase in tear film lipid layer thickness following treatment with warm compresses in patients with meibomian gland dysfunction. Eye Contact Lens. 2003 Apr;29(2):96-9.
2. Blackie CA, Solomon JD, Greiner JV, et al. Inner eyelid surface temperature as a function of warm compress methodology. Optom Vis Sci. 2008 Aug;85(8):675-83.

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Lissamine Green (LG) is an organic dye, which is used for demonstrating ocular surface staining. LG preferentially stains membrane-damaged or devitalized cells.¹ This dye is mainly used to assess staining in the conjunctiva. LG is normally available for ophthalmic use as individually packaged, sterile strips. However, they (GreenGlo Ophthalmic strips) are no longer available in several countries including USA, Canada, Australia and UK. Liquid LG dye can serve as a good alternative until the LG strips make their way back to our shelves.

This week’s abstract focuses on a study that determined the optimal parameters of LG instillation for the examination of ocular surface in dry eye patients.² This study was conducted as a prospective and observational study that evaluated 16 eyes from eight dry eye patients with different levels of dry eye severity. Three volumes (5, 10, and 20 µl) of liquid LG (1%), was instilled using a pipette and four observers with different levels of clinical expertise examined the patients with and without red filter. All the investigators were masked. Oxford scale was used to document staining pattern of the conjunctiva and cornea within four minutes of dye instillation. Inter observer reliability and optimal volume of LG dye was assessed.

The results of this study show that ocular surface examination with instillation of 10 µl of 1% LG had good inter-observer reliability and was well tolerated, and was superior to 5 and 20 µl. Experienced observers preferred 10 µl of LG because of the ease of examination and accuracy. This study further showed that the use of red filter facilitates the examination of LG staining.

As highlighted in this week’s editorial and the above study, liquid LG is a good alternative to LG strips and can be ordered from a compounding pharmacy (e.g. Leiter's Compounding Pharmacy, San Jose). These pharmacies offer compounding medication, custom prescriptions and specialty compounding. Liquid LG can be administered using a pipette. If pipette is not available, 10 µl microcapillary tubes (Wiretol-Micropipettes, Drummond Scientific Co., Broomall, PA, USA) can be used to dispense the LG dye on to the ocular surface.

1. Kim J. The use of vital dyes in corneal disease. Curr Opin Ophthalmol 2000;11:241-247.
2. Hamrah P, Alipour F, Jiang S, Sohn JH, Foulks GN. Optimizing evaluation of Lissamine Green parameters for ocular surface staining. Eye (London, England) 2011;25:1429-1434.

PURPOSE: The recently published seminal dry eye workshop proceedings defined Lissamine Green (LG), an organic dye, as a gold standard for demonstrating ocular surface staining. The purpose of the current study was to determine the optimal parameters of 1% LG instillation for the ocular surface examination in dry eye patients. Design Prospective and observational quality improvement study.

METHODS: A quality improvement study evaluated 16 eyes from eight dry eye patients with different levels of severity. LG (1%), in three volumes (5, 10, and 20 µl) was instilled into the conjunctival cul-de-sac, and four masked observers with different levels of clinical expertise examined the patients with and without red filter. The staining pattern of the conjunctiva and cornea was documented with the Oxford scale within 4 min of LG instillation. Optimal volume and inter-observer reliability were assessed.

RESULTS: All dye volumes were tolerated well by all patients. Experienced observers preferred 10 µl volume because of the ease of examination and accuracy. Although instillation of 20 µl yielded similar scores as 10 µl, it resulted in overflow of the lid and facial skin staining. The use of red filter significantly improved reading scores (p>0.01). Inter-observer reliability was higher for conjunctival scores than for corneal scores for all patients. The highest reliability was demonstrated with 10 µlL volume and increased with greater experience of the observer.

CONCLUSIONS: Ocular surface examination with instillation of 10 µl 1% LG has good inter observer reliability and is well tolerated.

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Question: I want to give my patients better instructions about lid hygiene. Is there an update to baby shampoo?

Answer: Baby shampoo has long been recommended as a means to clean the eyelids due to its gentle surfactant properties and affordability. Many clinicians doubt its efficacy, and patients almost always neglect our “as directed” recommendations, which beg the question of what is considered efficacious (and realistic). If we only want to recommend general wellness to the non-disease-bearing patient, then it may be enough—it has to be better than nothing! For the patient with lid disease though, baby shampoo fails to sufficiently reduce the microbial load, and more aggressive hygiene is needed.