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Microsoft word - pharmaceutical update may.docx
Kristopher May, OD
Coldwater Vision Center
Southern College of Optometry (Adjunct)
The immediate future presents a significant shift in pharmaceuticals for Optometry and
Ophthalmology…but not only due to the products, due to industry changes. This course will cover all the
new developments from recent product launches to generic impact on our prescribing as well as what the
pipeline holds for the future.
I have served as a speaker for Alcon Labs, Addition Technologies, Sightpath Medical and Optos, Plc. I
serve on the advisory board for Sightpath Medical/Notal Vision and participate in clinical research trials
for Ciba Vision. Introduction
The immediate future presents a significant shift in pharmaceuticals as they pertain Optometry and
Ophthalmology…but not due to the products, due to industry changes.
FDA warning to Allergan (and $600M fine)
Shift to OTC as possible profit center for lower end Rx’s (Zaditor)
Soft Contact Lens Wetting Systems
2-(2-Hydroxy-3-(trimethylammonio) propoxy) ethyl cellulose (Polyquaterium-10)
Surface Acting Agents
EOBO Diblock Copolymer (?“HydraGlyde”)
Improves wettability and decreases hydrophobicity of the surface and bulk of SiHy lenses for up
Believed to act on both internal and external siloxane groups
Greiner, et al.
First clinical evaluation of Alcaftadine in treating the signs and symptoms of allergic conjunctivitis
Compared three concentrations of alcaftadine 0.05%, 0.1% and 0.25% with olopatadine hydrochloride
3,5 and 7 minutes c ocular itch and conj redness
Ocular Itch 16hr p Instillation
Is 16 hours long enough duration for complete all day symptom relief?
Percent Patients with ZERO Itch at Onset- CAC
BEPREVE* New to Brand Rxs Blepharitis – Clinical Presentation
Two primary forms:
Anterior Blepharitis – Affecting outer lid and lid margin. Often presents with acute symptoms
MGD – Meibomian gland dysfunction (Posterior Blepharitis). Typically a chronic progressive disorder
CURRENT STANDARD OF CARE
(Posterior Blepharitis / MGD / Meibomitis)
Nutrition Antibiotics* Artificial tears/lubricants
AzaSite: Off-Label Ideal for Blepharitis?
Broad-spectrum: active against most common bacteria responsible for blepharitis
Oral and intravenous azithromycin known for high tissue penetration2
Topical ophthalmic dosing results in sustained high levels in rabbit tear film and conjunctiva3
DuraSite is an adhesive matrix that stabilizes small molecules like azithromycin increases its
bioavalability in tissue2
Anti-Inflammatory Effects of Azithromycin
Anti-inflammatory effects which are dose dependent and independent of their antimicrobial effect
Reduce migration of neutrophils (Takeshita 1989)
Reduce production of pro-inflammatory cytokines (Hand 1990)
Phagocytosis (Kono 1994)
Anti-oxidant characteristics (Labro 1989)
MMP2/MMP9 Modulation in Human Corneal Epithelial Cells
Matrix metalloproteinases (MMPs) coordinate multiple processes in normal, damaged, and diseased
Over-expression of MMP-9 involves degradation of epithelial basement membrane and contributes to
failure of re-epitheliazation following injury, these elements can lead to repair defects and ulceration.
MMP-2 is elevated after wounding, collagen remodeling, and stromal repair.
The objective of this study was to determine the MMP modulatory effect of azithromycin (AzaSiteTM)
and its vehicle (DuraSite) on human corneal epithelial cells (HCEC) in vitro
Suppression of MMP9 in HCEC by AzaSite
Cultured human corneal epithelial cells secrete abundant pro-MMP-9 and pro-MMP-2.
AzaSite treatment suppressed pro-MMP-9 levels by 33% of the untreated control group, and showed a
suppressive effect greater than vehicle treatment.
FDA Letter to Inspire Pharmaceuticals
Journal Ad misbrands AzaSite in violation of the Act, 21 U.S.C. 352 (n); 321(n), and FDA implementing
regulations. 21 CFR 202.1(e)(5); (e)(6)(i); & (e)(7)(i) & (viii).
“DDMAC requests that Inspire immediately cease the dissemination of violative promotional materials
for AzaSite that contain violations such as those described above. Please submit a written response to
this letter on or before April 28, 2011, stating whether you intend to comply with this request, listing all
promotional materials (with the 2253 submission date) for AzaSite that contain violations such as those
described above, and explaining your plan for discontinuing use of such violative materials” OTC Options
MOA – Upon Instillation
MOA – On-The-Eye
Tear Film Break-up Time
SYSTANE® BALANCE Lubricant Eye Drops n = 40 Added 1 µl of NaFl Measurements: 15, 30, 60, and 120 minutes after a single-drop instillation
Wanting to use lubricant eye drops at least “some of the time” TFBUT < 5 sec MGD patients (either dropout or poor quality secretion)
“FreshKote’s unique patented blending and strengths of the following polymers achieves superior Dry Eye relief.”
2% Polyvinyl pyrrolidone .9% Polyvinyl alcohol (87% hydrolyzed) 1.8% Polyvinyl alcohol (99% hydrolyzed) Also contains Amisol® CLEAR
Amisol CLEAR, the phospholipid found in FreshKote, helps replenish and restore the lipid layer.
Lipid Layer is creating a barrier to evaporation and helps to stablize the tear film.
With its oncotic pressure, FreshKote normalizes the inward osmotic flow of water, slowing the
absorption of tears.
TOBRADEX® ST (tobramycin/dexamethasone ophthalmic suspension) 0.3%/0.05%
TOBRADEX® ST Suspension was designed to enhance bioavailability to the target tissues by increasing
the retention time on the ocular surface
In a randomized clinical study, mean aqueous dexamethasone concentrations of TOBRADEX® ST
Suspension and TOBRADEX® Suspension were statistically equivalent
Delivery Platform: Xanthan Gum In the bottle
Xanthan Gum and tobramycin form an ionic interaction
Reduces settling of dexamethasone in bottle On the ocular surface
Tears interrupt ionic interaction …Viscosity increases, Increases retention time
TOBRADEX® ST Suspension: increased 7-fold from bottle to tears in-vitro 80x compared to original Tobradex Suspension on the ocular surface
DUREZOL™ Emulsion Indication
DUREZOL™ (difluprednate ophthalmic emulsion) 0.05% approved June 23, 2008
Indication is for the treatment of inflammation and pain associated with ocular surgery
Dosage and administration beginning 24 hours after surgery is QID for 14 days, BID for 7 days, then
Developed by Mitsubishi as a dermatological preparation
Categorized as a “very strong” steroid in dermatology
Developed by Senju as an ophthalmic emulsion
June 2006, Licensed by Sirion Therapeutics
Percent of Subjects with Clearing of Anterior Chamber Cell Data
Mean Intraocular Pressure Data Gancyclovir Gel (Zirgan)
First innovation in the topical ophthalmic antiviral class in the U.S. in over 30 years.
Enhanced dosing regimen over current topical therapies.
Indicated for the treatment of acute herpetic keratitis (dendritic ulcers). The recommended dosing is
one drop five times
per day until the corneal ulcer heals, and then one drop three times
per day for
seven days Initial Antimicrobials in Eyecare
Morning of Tuesday, September 28, 1928 Alexander Fleming discovered penicillin
Cecil George Paine treated ophthalmia neonatorum and achieved the first cure on November 25, 1930.
Zymaxid (Gatifloxacin 0.5%)
“Patients 1 year of age or older: Instill one drop every two hours in the affected eye(s) while awake, up
to 8 times on Day 1. Instill one drop two to four times daily in the affected eye(s) while awake on Days 2
Often used bid as post-op dosing (Off Label)
Maximal Conjunctival Tissue Concentrations Future Anti-Infectives
Ocular bacterial infections: current and future treatment options
Expert Rev Anti Infect Ther. 2005 Feb ;3 (1):131-9 15757463
“Ophthalmologists are fortunate to be able to choose between an array of old and new antibiotics in
order to treat bacterial ocular infections…There is no immediate need for new ophthalmic antibiotics,
but increasing resistance is being seen with the widely used fluoroquinolone antibiotics
MRSA ocular isolates exhibited high resistance to all fluoroquinonlones (even 4th generation)
Found to be highly sensitive to vancomycin and gentamycin
Virtually 100% of systemic MRSA isolates are susceptible to trimethoprim (Septra) and sulfamethoxazole
Polytrim may be a good ocular choice
Currently in pipeline
Non-antibiotic, direct-acting therapy
“Broad Spectrum Anti-Microbial”
Anti-bacterial, viral, and fungal
Includes adenoviruses, herpes viruses and multidrug resistant species
Kill directly by destroying cell walls, proteins & nucleic acids
NVC-422 shows promise & is currently in human
Main issue is not systemic or farm use Pipeline Preview: What’s Up Next
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