Ora's inFocus newsletter brings you monthly updates on leading-edge advances across a wide array of ophthalmic therapeutic areas. Below is Ora's latest inFocus edition.

February 2012

In Focus Ora

Hello Colleague:

We invite you to review Ora’s February 2012 ophthalmology news by clicking on the links below.

Acanthamoeba Creeps into the Light
The past two decades have seen a series of microbial “epidemics” due to endemic protozoans in the genus Acanthamoeba. In the eye, these organisms can cause a keratitis which is difficult to diagnose, resistant to treatment and has the potential to be sight-threatening. While the infection caused by Acanthamoeba is often associated with contact lens use, particularly in Western countries, a retrospective assessment of outbreaks suggests that there are a number of factors involved in the epidemiology of Acanthamoeba keratitis. In this month’s column, we’ll take a look at recent AK outbreaks, consider the relative importance of various factors implicated in these outbreaks, and discuss the latest approaches to AK diagnosis and treatment.

January 2012 | Review of Ophthalmology
Author: Mark B. Abelson, MD, CM, FRCSC, FARVO, Ira Udell, MD, and James McLaughlin, PhD, Andover, Mass.

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Fungal Keratitis: The Lessons Learned
From 2005 to 2006, Fusarium keratitis gained notoriety when a fungal infection outbreak was associated with a certain contact lens solution. Though the incidence of fungal keratitis has since decreased, certain studies suggest that infection rates may once again spike due to an increase in the contact lens-wearing population and the rising trend of using multipurpose solutions, which have been shown to be less effective than peroxide systems.

NOVEMBER 2011 | REVIEW OF CORNEA & CONTACT LENSES
Author: Mark B. Abelson, M.D., C.M., Joseph Ciolino, M.D., and Caroline Tobey

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February 2012


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Allergy Drug Discovery and Development Conference

Jan 30-31, 2012 • San Diego, CA, USA

Ora presentations will include:

  • Paul Gomes - Speaking on “Allergic Conjunctivitis Models: Past, Present and Future”
  • Mark B. Abelson - Speaking on “Allergy Drug Discovery: Disease Modeling 101”

Learn More about GTCBio Allergy Drug Discovery and Development Conference



Glaucoma 360 New Horizons Forum

Friday, February 3, 2012 • The Palace Hotel, San Francisco, CA USA

At 2:15 pm, Ora’s President and CEO, Stuart B. Abelson, will moderate the Pharmaceutical Industry Panel.

Learn more about Glaucoma 360 New Horizons >>



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About Ora

For 30 years, Ora has been at the forefront of ophthalmic clinical research, building an unparalleled track record of success that includes full turnkey clinical services for 34 product approvals within the category. In fact, we have been directly involved in the development of over one-third of the world's currently marketed ophthalmic pharmaceutical products.

Learn More About Ora »

Therapeutic Areas
Allergy
Anti-Infective
Glaucoma
Dry Eye
Anti-Inflammatory
Retina
Drug Delivery
Diagnostic Equipment
Services
CMC
Pre-Clinical
Clinical Research
Consulting
Data Management
Biostatistics
Medical Writing
OraComm
Investigators
OraNet
OraNet Members
Research Opportunities
Support System
New Investigator Form
Contact
300 Brickstone Square
Andover, Massachusetts 01810
978.685.8900
info@oraclinical.com

 

Ora - 300 Brickstone Square Andover, MA 01810 (978) 685-8900

January 2012

In Focus Ora

Hello Colleague:

We invite you to review Ora’s January 2012 ophthalmology news by clicking on the links below.

The Promise of Genetic Testing

Through recent advances in ophthalmic genetics, genetic testing is beginning to drive medical vision care and slowly weave itself into clinical practice. Our knowledge of the human genetic landscape is evolving through efforts such as the Human Genome Project and the International Haplotype Map (HapMap) Project, and enthusiastic predictions about personalized medicine have followed from the sequencing of the human genome. Developments in molecular genetic testing heighten the expectation that, in the future, knowledge of genetic factors will play a role in disease prevention, early diagnosis, and management of common eye diseases that are the main causes of visual loss in the general population.

December 2011 | Retina Today
Author: Aron Shapiro; and Ashley Lafond

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The Pros and Cons of Dry-Eye Technologies
A look at the advantages and disadvantages of time-honored methods as well as new techniques and devices.

As we enter the dawn of dry-eye season and close the chapter on another year, it’s an appropriate time to reflect on the current state of dry-eye diagnosis and treatment as well as the prospects for therapeutic development in the coming year and beyond. In August, we ran through a list of dry-eye diagnostic tests, and discussed the critical value of a thorough patient history and a comprehensive discussion between doctor and patient about the patient’s ocular health. We also reviewed the standard clinical tests, namely fluorescein, rose bengal or lissamine green staining, tear-film breakup time, Schirmer’s tests and fluorophotometry, that are the current diagnostics used in formulating a dry-eye diagnosis. While these tests provide the clinician with clues for diagnosis, it’s clear that there’s room for improvement.

October 2011 - Review of Ophthalmology
Author: Mark B. Abelson, MD, CM, FRCSC, FARVO and the Ora Staff, Andover, Mass.

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January 2012


Allergy Drug Discovery and Development Conference

Jan 30-31, 2012 • San Diego, CA, USA

Ora presentations will include:

  • Paul Gomes - Speaking on “Allergic Conjunctivitis Models: Past, Present and Future”
  • Mark B. Abelson - Speaking on “Allergy Drug Discovery: Disease Modeling 101”

Learn More about GTCBio Allergy Drug Discovery and Development Conference



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About Ora

For 30 years, Ora has been at the forefront of ophthalmic clinical research, building an unparalleled track record of success that includes full turnkey clinical services for 34 product approvals within the category. In fact, we have been directly involved in the development of over one-third of the world's currently marketed ophthalmic pharmaceutical products.

Learn More About Ora »

Therapeutic Areas
Allergy
Anti-Infective
Glaucoma
Dry Eye
Anti-Inflammatory
Retina
Drug Delivery
Services
CMC
Pre-Clinical
Clinical Research
Consulting
Data Management
Biostatistics
Medical Writing
OraComm
Investigators
OraNet
OraNet Members
Research Opportunities
Support System
New Investigator Form
Contact
300 Brickstone Square
Andover, Massachusetts 01810
978.685.8900
info@oraclinical.com

Ora - 300 Brickstone Square Andover, MA 01810 (978) 685-8900

December 2011

In Focus Ora

Hello Colleague:

We invite you to review Ora’s December 2011 ophthalmology news by clicking on the links below.

Mucins: Foundation of A Good Tear Film
How do you describe a good tear film? Put simply, a good tear film is sticky on the bottom, juicy in the middle and greasy on top. While this may be an oversimplification, it’s also a good way to start a conversation about mucins—a vital component of a healthy ocular surface.

November 2011 | Review of Ophthalmology
Author: Mark B. Abelson, MD, CM, FRCSC, FARVO, Darlene Dartt, PhD, and James McLaughlin, PhD

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The Renaissance of Drug Delivery Systems for the Posterior Segment

Drug delivery to the posterior segment is hampered by the anatomy of the eye due to its inherent design, which dilutes and removes foreign material. In topically administered treatments, more than 90% of the drug from an eye drop will be lost before making it past the tear film. There is a considerable distance that a drug must travel to reach the posterior segment, and the journey is made more difficult by tear turnover and vascularized tissue absorption, with additional barriers such as the cornea, aqueous humor, and sclera. For years, the challenges in drug delivery to the posterior segment have proved difficult to overcome.

October 2011 - RETINA TODAY
Author: ARON SHAPIRO; AND ELIOT LAZAR, MD

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Measurement of ocular surface protection under natural blink conditions

To evaluate a new method of measuring ocular exposure in the context of a natural blink pattern through analysis of the variables tear film breakup time (TFBUT), interblink interval (IBI), and tear film breakup area (BUA).

September 2011 - Dovepress Journal
Author: Richard Abelson 1,2, Keith J Lane 3, Endri Angjeli 3, Patrick Johnston 3 , George Ousler 3, Douglas Montgomery 1

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December 2011


RegeneRx Reports Positive Data with RGN-259 in Phase 2 Dry Eye Trial

RegeneRX announced positive data from its 72-patient, Phase 2 clinical trial with RGN-259, a sterile, preservative-free eye drop, to evaluate its safety and efficacy for the treatment of signs and symptoms of dry eye syndrome over a treatment period of 30 days using the Controlled Adverse Environment (CAE) model.

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Ora Presents New Validation And Verification Data For Rhinitis Model At The American College Of Allergy, Asthma And Immunology

Ora, Inc., the world's leading ocular allergy research firm, will present a Scientific Poster titled “Validation and Verification of the Allergen BioCube Rhinitis Model with an Intranasal Corticosteroid” as part of The 2011 Annual Meeting of the American College of Allergy, Asthma & Immunology.

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About Ora

For 30 years, Ora has been at the forefront of ophthalmic clinical research, building an unparalleled track record of success that includes full turnkey clinical services for 32 product approvals within the category. In fact, we have been directly involved in the development of over one-third of the world's currently marketed ophthalmic pharmaceutical products.

Learn More About Ora »

Therapeutic Areas
Allergy
Anti-Infective
Glaucoma
Dry Eye
Anti-Inflammatory
Retina
Services
CMC
Pre-Clinical
Clinical Research
Consulting
Data Management
Biostatistics
Medical Writing
OraComm
Investigators
OraNet
OraNet Members
Research Opportunities
Support System
New Investigator Form
Contact
300 Brickstone Square
Andover, Massachusetts 01810
978.685.8900
info@oraclinical.com

Ora - 300 Brickstone Square Andover, MA 01810 (978) 685-8900

November 2011

In Focus Ora

Hello Colleague:

We invite you to review Ora’s November 2011 ophthalmology news by clicking on the links below.

Glaucoma and Dry Eye: A Tough Combo
As our patients age, an increased interest and heightened awareness of the changes occurring on the ocular surface is necessary. It’s not uncommon in this older patient population to see age-related changes on the ocular surface that affect the protective and nutrient functions of the tear film. These changes can include laxity of the lids, dropout of the meibomian glands, decrease in goblet cells and an increase in dry eye related to a decrease in acinar cells of both the main and accessory lacrimal glands. In fact, aging itself is a drying process. A decrease in body water in the elderly makes them susceptible to dehydration, and can play a factor in initiating or exacerbating ocular surface disease symptoms such as dryness, burning, stinging, grittiness and foreign body sensation.

October 2011 - Review of Ophthalmology
Author: Mark B. Abelson, MD, CM, FRCSC, FARVO, and Ashley Lafond, Andover, Mass.

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Clinical Trials in the Anti-VEGF Era
The efficacy of the intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents ranibizumab (Lucentis, Genentech) and bevacizumab (Avastin, Genentech) has revolutionized the treatment of wet age-related macular degeneration (AMD). Historically, treatments for wet AMD, such as macular photocoagulation, verteporfin photodynamic therapy (Visudyne PDT, QLT), and pegaptanib sodium (Macugen, Eyetech), the first intravitreal anti- VEGF therapy to be approved, were only able to slow the rate of vision loss in a subset of wet AMD patients.

September 2011 - RETINA TODAY
Author: ARON SHAPIRO, PETER L. SONKIN, MD, ROBERT E. LEONARD II, MD

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In the Blink of an Eye
Picture driving down the freeway in your Mercedes Benz S-600 after a long day of treating patients. You didn’t get enough sleep last night and you feel fatigue start to set in. Your eyes water, you blink faster, your head starts to nod… Beep, beep, beep! A set of alarms start ringing and you’re jolted back to reality—you almost fell asleep at the wheel. Now, how did your car know this?

September 2011 |Review of Cornea and Contact Lenses
Author: Mark B. Abelson, M.D., C.M., and Caroline Tobey

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November 2011


Ora has room to grow advancing allergy treatments

Ora, a 30-year-old family-owned life sciences services business in Andover, is expanding its reach with the launch of an innovative tool to help pharmaceutical companies advance drug research for allergy treatments.

The company’s $3 million Allergen Biocube, set to open next week in Middleton, is a living-room-size chamber that pipes in air filled with common allergens, to produce symptoms in clinical trial patients with seasonal or year-round allergies.

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About Ora

For 30 years, Ora has been at the forefront of ophthalmic clinical research, building an unparalleled track record of success that includes full turnkey clinical services for 32 product approvals within the category. In fact, we have been directly involved in the development of over one-third of the world's currently marketed ophthalmic pharmaceutical products.

Learn More About Ora »

Therapeutic Areas
Allergy
Anti-Infective
Glaucoma
Dry Eye
Anti-Inflammatory
Retina
Services
CMC
Pre-Clinical
Clinical Research
Consulting
Data Management
Biostatistics
Medical Writing
OraComm
Investigators
OraNet
OraNet Members
Research Opportunities
Support System
New Investigator Form
Contact
300 Brickstone Square
Andover, Massachusetts 01810
978.685.8900
info@oraclinical.com

Ora - 300 Brickstone Square Andover, MA 01810 (978) 685-8900

October 2011

In Focus Ora

Hello Colleague:

We invite you to review Ora’s October 2011 ophthalmology news by clicking on the links below.

Dr. Mark Abelson speaking at OIS in Orlando, FL on October 20th, 2011.
Later this month, Dr. Mark Abelson, Ora's Chairman and Chief Scientific Officer, will join a panel titled “Benefit vs. Risk at the FDA - How Does the FDA Judge and How Can Companies Plan?” at the Ophthalmology Innovation Summit’s (OIS) 3rd annual meeting in Orlando, FL on October 20th, 2011. The day-long meeting will be held immediately prior to the American Academy of Ophthalmology’s annual meeting.

For over 30 years, Dr. Abelson and the team at Ora have been providing strategic clinical regulatory guidance to ophthalmic firms large and small. Ora leads products and companies through the process of designing and executing a development program. Ora’s scientifically driven approach to regulatory strategy includes a unique offering of clinical models, validated scales, endpoints and patient subgroup identification technologies. With a successful track record of 32 drug approvals, Ora clients also benefit from our frequent interaction with the ophthalmic division of the FDA on the latest therapeutic technologies. Many of the companies presenting at OIS are Ora clients and we hope you’ll consider attending OIS to hear the exciting stories of their development success.

For more information on the summit, go to http://www.ophthalmologysummit.com/

What Makes Someone A Non-Responder?
In this month’s column we’ll discuss the topic of therapeutic non-responders and, in the process, touch on noteworthy aspects of drug development, drug metabolism and the genetic underpinnings of some of the examples of therapeutic non-responders we’re familiar with, and some new ones as well.

September 2011 - Review of Ophthalmology
Author: Mark B. Abelson, MD, CM, FRCSC, FARVO and James McLaughlin, PhD, Andover, Mass.

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A New Discovery: H4
The French novelist Marcel Proust once wrote, "The real voyage of discovery consists not in seeking new landscapes but in having new eyes." Ocular allergy researchers are gaining a new perspective on an old problem with the recent discovery of a new addition to the histamine receptor family: the H4 histamine receptors.

September 2011 |Review of Cornea and Contact Lenses
Author: Mark B. Abelson, MD, CM, FRCSC

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October 2011


Measurement of ocular surface protection under natural blink conditions

To evaluate a new method of measuring ocular exposure in the context of a natural blink pattern through analysis of the variables tear film breakup time (TFBUT), interblink interval (IBI), and tear film breakup area (BUA).

Continue Reading



First Patient Enrolled in SARcode Bioscience's Pivotal Dry Eye Study of SAR 1118 Ophthalmic Solution

SARcode Bioscience, Inc., a privately held biopharmaceutical company, announced that the initial patient has been enrolled in the company's pivotal Phase 3 clinical study (OPUS-1) of SAR 1118 ophthalmic solution.

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About Ora

For 30 years, Ora has been at the forefront of ophthalmic clinical research, building an unparalleled track record of success that includes full turnkey clinical services for 32 product approvals within the category. In fact, we have been directly involved in the development of over one-third of the world's currently marketed ophthalmic pharmaceutical products.

Learn More About Ora »

Therapeutic Areas
Allergy
Anti-Infective
Glaucoma
Dry Eye
Anti-Inflammatory
Retina
Services
CMC
Pre-Clinical
Clinical Research
Consulting
Data Management
Biostatistics
Medical Writing
OraComm
Investigators
OraNet
OraNet Members
Research Opportunities
Support System
New Investigator Form
Contact
300 Brickstone Square
Andover, Massachusetts 01810
978.685.8900
info@oraclinical.com

Ora - 300 Brickstone Square Andover, MA 01810 (978) 685-8900

September 2011

In Focus Ora

Hello Colleague:

We invite you to review Ora’s three September 2011 ophthalmology columns by clicking on the links below.

Ora Expands Its Next Generation Controlled Environment – The Allergen BioCube
Ora, Inc., the world’s leading independent ophthalmic research firm, announced today that it is expanding its newest clinical model, the Allergen BioCube (ABC) System, and building a new facility in response to increased demand for allergic rhinitis programs.

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The Pros and Cons of Dry-Eye Tests

Dry eye is a multifactorial disease that affects the quality and quantity of tears and alters the ocular surface. Patients may experience varying degrees of discomfort, including symptoms such as ocular burning, stinging, grittiness, foreign body sensation, sensitivity to light and blurriness.1 Signs such as keratitis are often noted to a greater or lesser degree.

August 2011 - Review of Ophthalmology
Author: Mark B. Abelson, MD, CM, FRCSC, George Ousler III, Ashley Lafond, Andover, Mass.

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September 2011


RegeneRx completes patient recruitment in Phase 2 dry eye drug trial

RegeneRx Biopharmaceuticals has completed patient recruitment in a placebo-controlled, double-masked Phase 2 trial to evaluate the safety and efficacy of RGN-259 as a treatment of dry eye syndrome.

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Akorn Acquires Minority Stake in Ophthalmic Drugs Firm Aciex

Akorn acquires minority stake in ophthalmic drugs firm Aciex Therapeutics, an ophthalmic drug development firm with a pipeline comprising both clinical- and preclinical-stage candidates. The investment was accompanied by a global licensing deal giving Akorn rights to a novel OTC eyecare product and a manufacturing agreement for one of Aciex’s lead prescription candidates.

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About Ora

For 30 years, Ora has been at the forefront of ophthalmic clinical research, building an unparalleled track record of success that includes full turnkey clinical services for 32 product approvals within the category. In fact, we have been directly involved in the development of over one-third of the world's currently marketed ophthalmic pharmaceutical products.

Learn More About Ora »

Therapeutic Areas
Allergy
Anti-Infective
Glaucoma
Dry Eye
Anti-Inflammatory
Retina
Services
CMC
Pre-Clinical
Clinical Research
Consulting
Data Management
Biostatistics
Medical Writing
OraComm
Investigators
OraNet
OraNet Members
Research Opportunities
Support System
New Investigator Form
Contact
300 Brickstone Square
Andover, Massachusetts 01810
978.685.8900
info@oraclinical.com

Ora - 300 Brickstone Square Andover, MA 01810 (978) 685-8900

August 2011

In Focus Ora

Hello Colleague:

We invite you to review Ora’s three August 2011 ophthalmology columns by clicking on the links below.

The 2011 ARVO Highlight Reel

The theme for the 2011 meeting of the Association for Research in Vision and Ophthalmology was “Visionary Genomics,” and genomics presentations overlapped with two other major themes of the meeting: new imaging technologies and regenerative medicine in ophthalmology. These and other cutting-edge approaches, including pre-clinical and clinical studies, were the subject for posters, talks and symposia.

July 2011 - Review of Ophthalmology
Author: Mark B. Abelson, MD, CM, FRCSC, and the Ora staff, Andover, Mass.

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Non-Compliance: A Continued Concern

Non-compliance is an ongoing problem among contact lens wearers, as a majority of wearers neglect to follow the manufacturer, prescriber or clinicians recommendations for periods of time. While the development of frequent replacement contact lenses and simplified cleaning procedures were attempts to improve compliance and reduce contact lens-related ocular problems, overwear still remains an issue.

June 2011 - Review Of Cornea and Contact Lenses
Author: Mark B. Abelson, M.D., C.M., and Jason R. Chin, O.D.

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'As Good As' or 'No Worse Than'

Age-related macular degeneration (AMD) is the leading cause of severe vision loss in people over the age of 65 in the United States, with more than 1.6 million people currently affected by advanced AMD. In light of the recent publication of the 1-year interim results of the Comparison of Age- Related Macular Degeneration Treatments Trial (CATT), a multicenter, randomized clinical trial designed to assess the relative safety and efficacy of two treatments for subfoveal neovascular AMD, a closer look at what it means to conduct a noninferiority study is warranted.

May/June 2011 - RETINA TODAY
Author: ARON SHAPIRO; MICHAEL BYRNES,PHD; AND ASHLEY LAFOND

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August 2011


Euclid Systems partners with Ora, Inc. for development of its novel collagen-based drug delivery system for glaucoma treatment

Euclid Systems is pleased to announce that it has selected Ora, Inc. of Andover, MA to conduct pre-clinical and clinical development of its novel collagen-based drug delivery system for the treatment of glaucoma. This innovative product is intended to improve glaucoma patient compliance by providing sustained release of active ingredients over a period of months.

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RegeneRx Set to Begin Enrolling Phase 2 Dry Eye Trial

RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) has announced that it is set to begin a Phase 2 clinical trial in 72 patients with dry eye syndrome. The Company anticipates enrollment of the first patients on August 13th, and expects preliminary data from the study to be available in October 2011.

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About Ora

For 30 years, Ora has been at the forefront of ophthalmic clinical research, building an unparalleled track record of success that includes full turnkey clinical services for 32 product approvals within the category. In fact, we have been directly involved in the development of over one-third of the world's currently marketed ophthalmic pharmaceutical products.

Learn More About Ora »

Therapeutic Areas
Allergy
Anti-Infective
Glaucoma
Dry Eye
Anti-Inflammatory
Retina
Services
CMC
Pre-Clinical
Clinical Research
Consulting
Data Management
Biostatistics
Medical Writing
OraComm
Investigators
OraNet
OraNet Members
Research Opportunities
Support System
New Investigator Form
Contact
300 Brickstone Square
Andover, Massachusetts 01810
978.685.8900
info@oraclinical.com

Ora - 300 Brickstone Square Andover, MA 01810 (978) 685-8900

July 2011

In Focus Ora

Hello Colleague:

We invite you to review Ora’s three July 2011 ophthalmology columns by clicking on the links below.

It's Time to Think About the Blink
It's Time to Think About the Blink It's amazing to think of how complicated a seemingly simple action can be. The "blink of an eye" is an often-used phrase to describe things that begin and end before we have time to even realize they're happening. And blinking, the autonomic, reflexive closing of the eye is one of those apparently simple actions that, upon closer inspection, is exceedingly complex.

June 2011 - Review of Ophthalmology
Author: Mark B. Abelson, MD, CM, FRCSC, and the Ora staff, Andover, Mass.

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Identifying Subgroups of Dry Eye Patients
Identifying Subgroups of Dry Eye Patients Dry eye syndrome may be one of the most common diseases that eye care providers encounter in daily practice. Patients who present with symptoms are diagnosed with dry eye after they undergo diagnostic testing. Yet, the diagnostic tools available to clinicians to clearly define dry eye have been limited or underutilized. Although an objective measurement is the only way to definitively diagnose dry eye, virtually no diagnostic tools, with the exception of tear osmolarity, are reimbursable.

May/June 2011 - Advanced Ocular Care
Author: George W. Ousler III

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What's new in topical drugs?
The key to treating any disease is to know your enemy before engaging in the battle. Even with the evolved understanding in the ophthalmic industry, ocular pathogens adapt quickly to the numerous efforts to fight them. Thus, the anti-infective and anti-inflammatory methods of treatment are constantly challenged to keep pace.

May 2011 - Ophthalmology Times
Author: Aron Shapiro

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July 2011


Ora's Dry Eye Department

Over the past 15 years, Ora has evaluated over ten thousand patients across 215 dry eye trials, looking at 30 investigational drugs including hormonal therapies, secretagogues, mucomimetics, anti-evaporatives, anti-inflammatories and nutritional supplements.To learn more view our presentation:

"Clinical Trial and Regulatory Challenges in the Development of Dry Eye Therapies"

Presented by Stuart B. Abelson, President and CEO of Ora, Inc.

Watch the Video



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About Ora

For 30 years, Ora has been at the forefront of ophthalmic clinical research, building an unparalleled track record of success that includes full turnkey clinical services for 32 product approvals within the category. In fact, we have been directly involved in the development of over one-third of the world's currently marketed ophthalmic pharmaceutical products.

Learn More About Ora »

Therapeutic Areas
Allergy
Anti-Infective
Glaucoma
Dry Eye
Anti-Inflammatory
Retina
Services
CMC
Pre-Clinical
Clinical Research
Consulting
Data Management
Biostatistics
Medical Writing
OraComm
Investigators
OraNet
OraNet Members
Research Opportunities
Support System
New Investigator Form
Contact
300 Brickstone Square
Andover, Massachusetts 01810
978.685.8900
info@oraclinical.com

Ora - 300 Brickstone Square Andover, MA 01810 (978) 685-8900

June 2011

In Focus
Ora
June 2011

Hello Colleague:

We invite you to review Ora’s three June 2011 ophthalmology columns by clicking on the links below.
May 2011 - Review of Ophthalmology

Dry-Eye Studies: Beware These Pitfalls

Everything from environmental and seasonal factors to the placebo effect can confound a study’s results.

Mark B. Abelson, MD, CM, FRCSC, George Ousler III and Ashley Lafond

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May 2011 - Ophthalmology Times

Dry eye pipeline full of potential

Anti-inflammatories, resolvins, delivery systems, mucin secretagogues are under study

George W. Ousler, III

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May 2011 - Review of Cornea and Contact Lenses

BAKtracking Contact Lens Guidelines

Although an effective preservative, eye care practitioners need a better understanding of how BAK interacts with contact lens wear.

Mark B. Abelson, M.D., C.M., Gail Torkildsen, M.D., and Caroline Tobey

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News & Press

iCo Therapeutics Inc. Engages Ora for Ophthalmic Clinical & Regulatory Guidance

iCo Therapeutics Inc. (TSX-V: ICO) announced that it has entered into a consulting agreement with Ora Inc., ("Ora"), a global leader in ophthalmic product development. Ora´s scope of services relate to iCo-007 Phase 2 clinical development.

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RegeneRx Reports New Statistically Significant Data Confirming Repair of Corneal Damage in Ora's Dry Eye Model

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About Ora

For 30 years, Ora has been at the forefront of ophthalmic clinical research, building an unparalleled track record of success that includes full turnkey clinical services for 32 product approvals within the category. In fact, we have been directly involved in the development of over one-third of the world's currently marketed ophthalmic pharmaceutical products.

Learn More About Ora »

Therapeutic Areas
Allergy
Anti-Infective
Glaucoma
Dry Eye
Anti-Inflammatory
Retina
Services
CMC
Pre-Clinical
Clinical Research
Consulting
Data Management
Biostatistics
Medical Writing
OraComm
Investigators
OraNet
OraNet Members
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Support System
New Investigator Form
Contact
300 Brickstone Square
Andover, Massachusetts 01810
978.685.8900
info@oraclinical.com

Ora - 300 Brickstone Square Andover, MA 01810 (978) 685-8900

May 2011

In Focus
Ora
May 2011

Hello Colleague:

From May 1 through May 5, Ora will be presenting 19 scientific posters at the ARVO Annual Meeting in Fort Lauderdale, Florida. These 19 posters are the largest number of Ora posters ever presented at ARVO during Ora’s 30-year history.

13 of these 19 scientific posters represent research conducted by the Ora Institute, Ora’s R&D arm that is solely dedicated to advancing ophthalmic product development by conducting “research on research.” These posters will cover both clinical and preclinical research advancements made across a wide array of ophthalmic therapeutic areas, including Dry Eye, Meibomian Gland Dysfunction (MGD), Allergy, and Retina. Several of the posters include the Ora Institute’s latest model and methodology developments, such as the OPI 2.0 System and the Allergen BioCube.

We look forward to seeing you next week at ARVO, and as always, we invite you to review Ora’s three newest ophthalmology columns by clicking on the links below.

April 2011 - Review of Cornea & Contact Lenses

The Foolish Things Patients Do

Practitioners should educate their patients about the common and uncommon everyday risks of injury to the eye.

Mark B. Abelson, MD, CM, FRCSC and Ashley Lafond, Caroline Tobey

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April 2011 - Review of Ophthalmology

Ocular Antihistamines Revisited: Beyond H1

Breaking down the body’s histamine receptors and focusing on the characteristics of one in particular: the H4 receptor.

Mark B. Abelson, MD, CM, FRCSC and James McLaughlin, PhD, Andover, Mass.

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April 2011 - RETINA TODAY

Proper Documentation in Clinical Trials

Business Of Retina Clinical Trials For The Retina Specialist

Aron Shapiro; Nour Ziyadeh; David Waters-Honcu; Sunita Saigal; and Ashley Lafond

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ARVO 2011 May 1 - May 5
The Ora Institute
The Ora Institute

The Ora Institute will be presenting 13 scientific posters at the 2011 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting

Ora Institute Scientific Advances »


See The Ora Institute's 13 scientific posters at ARVO

Download Our 2011 ARVO Poster Calendar »


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About Ora

For 30 years, Ora has been at the forefront of ophthalmic clinical research, building an unparalleled track record of success that includes full turnkey clinical services for 32 product approvals within the category. In fact, we have been directly involved in the development of over one-third of the world's currently marketed ophthalmic pharmaceutical products.

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Ora - 300 Brickstone Square Andover, MA 01810 (978) 685-8900

April 2011

In Focus
Ora
April 2011

Hello Colleague:

Each month here at Ora, we work to provide you with scientific content that is both insightful and timely.

For your convenience, we have added a feedback link to this email. Please tell us what you think about our content choices, so that we can continue to deliver you the information that you find most relevant. In the meantime, we invite you to review Ora’s three April 2011 ophthalmology columns by clicking on the links below.

March 2011 - Review of Cornea and Contact Lenses

Think Globally, Treat Locally: Treating Allergic Rhinitis

For patients with mild to moderate allergic rhinitis, implement a preventative treatment strategy by first prescribing a topical ophthalmic antihistamine.

Authors: Mark B. Abelson, M.D., C.M., and Donna Jensen, Ph.D.

Continue Reading »
March 2011 - RETINA TODAY

Clinical Trials For The Retina Specialist:

First Study Visit Success

Authors: Gail L. Torkildsen, MD; David Waters-Honcu; and Ashley Lafond

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March 2011 - Review of Ophthalmology

A Partial Solution to Steroid Side Effects

Approaches include new steroid and antihistamine formulations, dual-agent therapies

Authors: Mark B. Abelson, MD, CM, FRCSC and James McLaughlin, PhD, Andover, Mass.

Continue Reading »

Find out why Ora’s comprehensive Dry Eye Research System is more precise than any other.

Clinical Trial and Regulatory Challenges in the Development
of Dry Eye Therapies


Ora welcomes Larry Amdahl
as new director of clinical operations for Dry Eye

In his new role, Larry will be responsible for overseeing both the tactical execution of clinical programs and the planning and process evolution of Ora's Dry Eye Operations group. Continue Reading »

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Tell us what you think >>

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About Ora

For 30 years, Ora has been at the forefront of ophthalmic clinical research, building an unparalleled track record of success that includes full turnkey clinical services for 32 product approvals within the category. In fact, we have been directly involved in the development of over one-third of the world's currently marketed ophthalmic pharmaceutical products.

Learn More About Ora »

Therapeutic Areas
Allergy
Anti-Infective
Glaucoma
Dry Eye
Anti-Inflammatory
Retina
Services
CMC
Pre-Clinical
Clinical Research
Consulting
Data Management
Biostatistics
Medical Writing
OraComm
Investigators
OraNet
OraNet Members
Research Opportunities
Support System
New Investigator Form
Contact
300 Brickstone Square
Andover, Massachusetts 01810
978.685.8900
info@oraclinical.com

Ora - 300 Brickstone Square Andover, MA 01810 (978) 685-8900

March 2011

In Focus
Ora
March 2011

Hello Colleague:

We hope to see you at the AAAAI Annual Meeting in San Francisco this month, as a number of our Ora professionals will be in attendance. In the meantime, we invite you to
review Ora’s three March 2011 ophthalmology columns by clicking on the links below.

February 2011 - Review of Ophthalmology

A Guide for Breaking Down Blepharitis

An attempt to nail down a treatment and diagnosis for a disease that defies clean definitions.

Authors: Mark Abelson, MD, CM, FRCSC, Aron Shapiro and Caroline Tobey, Andover, Mass.

Continue Reading »
January 2011 - RETINA TODAY

Clinical Trials For The Retina Specialist:

Recruiting for the Long Run

Authors: Avner Ingerman, MD, MSc; Ashley Lafond; David Waters-honcu; And Sunita Saigal

Continue Reading »
February 1, 2010 - Ophthalmology Times

What’s next in ocular allergy?

Approaches include new steroid and antihistamine formulations, dual-agent therapies

Authors: Paul J. Gomes, MS

Continue Reading »
Future Events:
AAAAI, San Francisco, California
AAAAI, San Francisco, California

March 18 - 22
Schedule your meeting with Shreelekha Mandal at this event. »
call: 978.332.9415

View all upcoming events »

AAAAI Poster

Sat, Mar 19, 9:45 - 10:45 AM
193 - Development of a Standardized Clinician-Graded Scale for Assessment of Nasal Turbinate Inflammation Induced by Exposure to the Allergen BioCube

P. Gomes1, M. B. Abelson1,2, K. Lane1, E. Angjeli1;


Mimetogen Pharmaceuticals
Read Mimetogen's press release that describes the role of Ora’s CAE Dry Eye Model in their Phase II trial.
Read More »


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About Ora

For 30 years, Ora has been at the forefront of ophthalmic clinical research, building an unparalleled track record of success that includes full turnkey clinical services for 32 product approvals within the category. In fact, we have been directly involved in the development of over one-third of the world's currently marketed ophthalmic pharmaceutical products.

Learn More About Ora »

Therapeutic Areas
Allergy
Anti-Infective
Glaucoma
Dry Eye
Anti-Inflammatory
Dermatology
Retina
Services
CMC
Pre-Clinical
Clinical Research
Consulting
Data Management
Biostatistics
Medical Writing
OraComm
Investigators
OraNet
OraNet Members
Research Opportunities
Support System
New Investigator Form
Contact
300 Brickstone Square
Andover, Massachusetts 01810
978.685.8900
info@oraclinical.com

Ora - 300 Brickstone Square Andover, MA 01810 (978) 685-8900

February 2011


February 2011

Hello Colleague:

Below you will find the latest releases from Ora. Follow us on Twitter and get the latest content releases.
January 2011 - Review of Cornea and Contact Lenses

Diagnose that Disease: Blepharitis

Accurately diagnosing blepharitis and prescribing the most fitting treatment remains a challenge.

Authors: Mark B. Abelson, M.D., C.M., Aron Shapiro and Caroline Tobey

Continue Reading »
December 2010 - Review of Ophthalmology

Do Your Homework Before Treating CME

When using a drug off-label, it's crucial to amass as much knowledge as possible.

Authors: Mark B. Abelson, MD, FRCSC, Ashley Lafond

Continue Reading »
November / December 2010 - Retina Today

Clinical Trials For the Retina Specialist: Clinical Trial Site Start-Up

Authors: Avner Ingerman, MD, MSC; Ashley Lafond; David Waters-Honcu; and Sunita Saigal

Continue Reading »
Future Events:
About Ora

For 30 years, Ora has been at the forefront of ophthalmic clinical research, building an unparalleled track record of success that includes full turnkey clinical services for 32 product approvals within the category. In fact, we have been directly involved in the development of over one-third of the world's currently marketed ophthalmic pharmaceutical products.

Learn More About Ora »

Therapeutic Areas
Allergy
Anti-Infective
Glaucoma
Dry Eye
Anti-Inflammatory
Dermatology
Retina
Services
CMC
Pre-Clinical
Clinical Research
Consulting
Data Management
Biostatistics
Medical Writing
OraComm
Investigators
OraNet
OraNet Members
Research Opportunities
Support System
New Investigator Form
Contact
300 Brickstone Square
Andover, Massachusetts 01810
978.685.8900
info@oraclinical.com

Ora - 300 Brickstone Square Andover, MA 01810 (978) 685-8900

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