By: Paul M. Karpecki, OD, FAAO Clinical Director – PECAA

This is a question I receive often and seemed like a good feature for the mid-year newsletters. As I started researching this question it quickly became evident that a lot has happened in the world of dry eye/ ocular surface disease in a short time. It was so extensive we had to divide it into two parts.

Kala KPI-121

This drug is 0.25% loteprednol for the treatment of dry eye disease (DED) flare ups. The drug is in phase III clinical trials for a potential approval in late 2019 or early 2020.  It will be interesting to see if we have a new drug with a treatment for a critical component of DED. What you need to know:

  • Dry eye is a chronic inflammatory disease with flares that are characterized by acute exacerbations of signs and/or symptoms
  • A dry eye flare is a rapid onset, inflammation-driven response to a variety of triggers that typically cannot be adequately managed with the patient’s ongoing therapy
  • Regardless of dry eye severity, flares typically occur 4-6 times per year
  • The concentration is 0.25% and the vehicle involves mucous penetrating particles (MPPs) which are nanoparticle in size (<500 nm) to achieve efficacy and tissue penetration through mucus pores

VitalTears

Having access to autologous serum eye drops (ASEDs) is essential in managing dry eye within a practice.  Up to now there has not been easy access and patients can’t ship their blood far for processing etc. A new company called VitalTears has an affordable and extremely patient friendly approach to providing this essential treatment option. What you need to know:

  • Autologous serum has the same components as our tears but typically in higher concentrations. 
    Recall that our accessory lacrimal glands essentially take the serum in the blood supply to create tears. Patients who cannot make their own tears (KCS, Sjogrens’  Syndrome KCS, neurotrophic  keratitis) rely on this product enters nothing that completely substitute for a patient’s tears compared to autologous serum
  • Conditions that typically require ASEDs include KCS, NK, limbal stem cell deficiency, chronic corneal staining,  persistent epithelial defects and even recurrent corneal erosion to name a few

  • VitalTears has a phlebotomist that arrives at the patient’s home or work and draws the blood and the center processes it based on the doctors prescription for the optimal concentration

  • Most patients do well on a 25% concentration although doctors can prescribe up to 100%. Almost all my patients are on 25% concentration although I’ve used 40% in very advanced diseases such as significant neuotrophic ulcers

Acthar

Acthar is an corticotropin IM or SC injection, which allows the body to provide its own adrenal glucocorticosteroid response. It stimulates the body’s anti-inflammatory responses for treatment of conditions such Sjogrens KCS or uveitis. You need to know:

  • Acthar is approved for the treatment of severe acute and chronic inflammatory disorders of the eye
  • Acthar r binds to melanocortin receptors and elicits both steroid-dependent and independent properties
  • It has decades of clinical experience across multiple disease states since approval for use more than 65 years ago and when you prescribe this, an at home healthcare provider can dose the patient at home or wherever is convenient for them
  • Usual dose is 40 to 80 units every 24 to 72 hour but dose and duration of therapy should be individualized for each patient
  • Patient training and support available through Mallinckrodt Pharmaceuticals

CEQUA

This newest form of cyclosporine was actually approved by the FDA late last year, because of manufacturing issues it has not been available, until now. What you need to know:

  • This drug class is known as calcineurin inhibitor immunosuppressants indicated for increased tear production in patients with KCS
  • Dosing is b.i.d. and the concentration is 0.09%
  • The formulation involves a nanomicelle, which has a hydrophobic core where the cyclosporine is housed surrounded by a hydrophilic outer layer that allows for greater ocular penetration
  • This hydrophilic outer layer is compatible with the aqueous layer of the tear film allowing for transport to the ocular surface, where the drug is then released
  • The drug showed a statistically significant improvement in Schirmer scores and total corneal staining compared to vehicle at day 84. The most common adverse event was installation site pain in about 24% of patients

Oasis Tears and Oasis Tears Plus

New research reports1 have recently come out showing the incredible benefit of hyaluronic acid (HA) based drops. You need to know:

  • The highest concentration of HA currently available in a drop is Oasis Tears Plus, but HA is also found in Bio True contact lens solutions and artificial tears such as Blink
  • An interesting paper was recently published comparing cyclosporine eyedrops to drops containing HA
  • Administration of 0.1%, 0.15%, and 0.3% HA was effective in improving both the objective signs and subjective symptoms of dry eye. Those findings, in addition to the well-tolerated profile, show that it is an effective therapeutic option for dry eye
  • The results concluded noninferiority and in some cases better results

OcuSoft Lid Scrub Allergy Eyelid Cleanser

OcuSoft has long been a trusted and effective hygiene company with the largest market share of lid scrubs and hygiene cleansers. This month they introduced a novel allergy eyelid cleanser.  What you need to know:

  • It comes in premoistened pads
  • In addition to removing pollen, debris, allergens, oils and contaminants it also treats the itching, inflammation and redness
  • Inflammation is targeted via ingredients such as green tea extract, itching via tea tree oil and redness with PSG–2 (phytosphingosine) an ingredient used for redness in current rosacea treatments
Meibography of a healthy patient

 

Meibography of a patient with advanced dry eye and rosacea

Oculus Keratograph M5

Oculus has come out with a new approach to making one of the very best dry eye diagnostic technologies available to clinicians. What you need to know:

  • The technology is priced where other meibographer reside but has added technologies. For
    example you can get Oculus meibography with non-invasive tear break up time and tear meniscus height measurements in a single unit
  • Topography is available in a higher priced model and other dry eye features
  • There are three technology options and you can customize reports as needed to come up with your final Keratograph M5 package
  • This is truly one of the best systems for dry eye diagnosis and technically provides almost everything the TFOS DEWS II diagnostic committee recommends in one technology
  • The world of ocular surface disease continues to expand and advance.  These are indeed terrific opportunities for our practices and our patients.
Summary:
1.  Park Y. Et al. A Randomized Multicenter Study Comparing 0.1%, 0.15%,  and 0.3% Sodium Hyaluronate with 0.05% Cyclosporine in the Treatment of Dry Eye.  Journal of ocular pharmacology and therapeutics. 33(2):66-72

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