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About New

Creating Vision Beyond What We See

Who We Are

Ora was founded on a dedication to advancements and innovations in ophthalmology. For over 40 years, we have been on the cutting edge of ophthalmic product development.

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Some of Our Clients

Executive Team

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Stuart Abelson

President, Chairman and CEO
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Sunya Andrews

Chief People and Culture Officer
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Andrew Warner

General Counsel
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Sally Tucker

Vice President, Ora Europe
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Mark Trus

Chief Financial Officer
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David Bingaman

Chief Development Officer

Global Presence

Local teams around the world with the experience you need for
successful product development

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Comprehensive support

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Offices in North America, Europe, Asia, and Australia

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Ora team members in over 15 countries

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International experts are there to help throughout the entire product development lifecycle

Ophthalmology is Our Only Focus and Priority

The Vision and Experience to Guide Your Product Development

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Anterior Segment

Extensive experience supporting our customers across various indications

Anterior Segment

Extensive experience supporting our customers across various indications including:

Dry Eye: 30 therapies evaluated including 2 most recent, novel approvals: Xiidra and TrueTear

Allergy: Supported partners in the approval of 23 products

20,000+

Patients Enrolled

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Posterior Segment

Industry leader in IRDs, Wet/Dry AMD, and Glaucoma

Posterior Segment

Industry leader in IRDs, Wet/Dry AMD, and Glaucoma

Advancing research with innovative capabilities and novel endpoints

Retina R&D Team dedicated to clinical model and endpoint development

8,000+

Patients Enrolled

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Device

Global clinical and regulatory experience at all levels of research

Device

Global clinical and regulatory experience at all levels of research in areas including IOLs, OCT, and Contact Lenses

30+ FDA pre-submissions
10+ PMA/HDE
20+ 510(k)
In recent years

2,000+

Patients Enrolled

Recent Global Ophthalmic Experience

Indications

Click the buttons below to learn about each indication’s totals from
the last 5 years.

Sites

42

90

325

434

71

202

1

99

75

308

78

8

172

Site Locations

US

US, EUROPE

US, CHINA

US, CANADA, SINGAPORE, DOMINICAN REPUBLIC, JAPAN

US, JAPAN

US, EUROPE, AUSTRALIA

US

US

US, EUROPE

US, CANADA, ISRAEL, BRAZIL, EUROPE

US

AUSTRALIA

US, CANADA, EUROPE

Enrolled Subjects

1438

2543

13353

4934

2953

1127

120

1924

729

2515

283

219

2753

Phases

0,2,3

PILOT/
PIVOTAL
1,3

0,1,2,3,4

1,2,3

0,1,2,3

0,1,2

1

1,2,3

1,2

0,1,2,3

3,4

2

2,3,4

Early Engagement Support

Click on each tab to learn more.

Milestone data to make important decisions in the early stages of product development

  • Compound identification for ophthalmic utility
  • Ophthalmic formulation guidance
  • PK, ocular irritation (safety studies)
  • Animal efficacy models spanning a wide range of ophthalmic diseases
  • Customized study design, depending on compound, indication and MOA
  • Development and management of GLP toxicology programs to support regulatory filings

In-house experts help you navigate the development process

From consulting and submissions to turnkey clinical trial supply management

  • Monthly interaction with global regulatory authorities including FDA, PMDA, EMA, and Notified Bodies across all phases and ophthalmic indications
  • Comprehensive regulatory writing services and electronic submissions
    • Pre-IND, IND, CTA, IDE, NDA, PIP, EU procedures (CP, NP, MRP, DCP)
    • 510(k) and PMA Applications for devices
    • Clinical Protocols
    • Clinical Study Reports (CSRs)
  • Regulatory intelligence of country-specific requirements for European CTA, MAA and ROW
  • Expertise in managing ophthalmic formulation and sterile dose form development
  • Strategic relationships with GMP manufacturers and laboratories with preferred pricing and scheduling
Preclinical Services

Milestone data to make important decisions in the early stages of product development

  • Compound identification for ophthalmic utility
  • Ophthalmic formulation guidance
  • PK, ocular irritation (safety studies)
  • Animal efficacy models spanning a wide range of ophthalmic diseases
  • Customized study design, depending on compound, indication and MOA
  • Development and management of GLP toxicology programs to support regulatory filings
Regulatory Strategy and CMC Consulting

In-house experts help you navigate the development process

From consulting and submissions to turnkey clinical trial supply management

  • Monthly interaction with global regulatory authorities including FDA, PMDA, EMA, and Notified Bodies across all phases and ophthalmic indications
  • Comprehensive regulatory writing services and electronic submissions
    • Pre-IND, IND, CTA, IDE, NDA, PIP, EU procedures (CP, NP, MRP, DCP)
    • 510(k) and PMA Applications for devices
    • Clinical Protocols
    • Clinical Study Reports (CSRs)
  • Regulatory intelligence of country-specific requirements for European CTA, MAA and ROW
  • Expertise in managing ophthalmic formulation and sterile dose form development
  • Strategic relationships with GMP manufacturers and laboratories with preferred pricing and scheduling

Investing in Novel Endpoints

Innovating to bring advanced solutions to customers and patients

Mobile units that create environment where the ocular surface is stressed to react to humidity, temperature, airflow and visual tasking

  • Provide endpoints that demonstrate change with intervention
  • Identify and enroll the appropriate patient population

Within a controlled environment, patients are exposed to a specified dosage of allergen

  • Extremely precise and reproducible
  • Reduces the number of patients and sites needed to gain more meaningful, tighter datasets
  • Highly standardized grading systems increase sensitivity

Immerses patients in a 360° visual challenge environment, assessing changes in patient mobility that are secondary to improvement in vision

  • Effectively assess impact of therapies on IRDs
  • Clinically meaningful assessment of vision

Variable contrast flicker test and low luminance reading tests can differentiate normal vs early dry AMD

  • Potential endpoints for dry AMD trials
  • Possible screening tools to identify subjects with underlying visual dysfunction to enrich enrollment

Proprietary device for ocular imaging captured remotely for real-time review

  • Specialty mold based on extensive testing of orbital shapes and crafted into a one-size-fits-all design
  • Patients can take images at home and submit to a web-based platform through automatic uploads along with diaries
Ora CAE® Dry Eye Challenge

Mobile units that create environment where the ocular surface is stressed to react to humidity, temperature, airflow and visual tasking

  • Provide endpoints that demonstrate change with intervention
  • Identify and enroll the appropriate patient population
Ora-CAC Allergen Model & Allergen BioCube Allergy Chamber

Within a controlled environment, patients are exposed to a specified dosage of allergen

  • Extremely precise and reproducible
  • Reduces the number of patients and sites needed to gain more meaningful, tighter datasets
  • Highly standardized grading systems increase sensitivity
Ora-VNC™ Mobility Courses

Immerses patients in a 360° visual challenge environment, assessing changes in patient mobility that are secondary to improvement in vision

  • Effectively assess impact of therapies on IRDs
  • Clinically meaningful assessment of vision
DRY AMD Endpoints

Variable contrast flicker test and low luminance reading tests can differentiate normal vs early dry AMD

  • Potential endpoints for dry AMD trials
  • Possible screening tools to identify subjects with underlying visual dysfunction to enrich enrollment
EyeCup™ Smartphone Device

Proprietary device for ocular imaging captured remotely for real-time review

  • Specialty mold based on extensive testing of orbital shapes and crafted into a one-size-fits-all design
  • Patients can take images at home and submit to a web-based platform through automatic uploads along with diaries

OraNet™ Exclusive Site Network

Accelerate study start-up and patient recruitment

OraNet™ expands access to the pool of qualified ophthalmology specialists available to conduct clinical trials

Access established networks of patients to find the right population for your study

OraNet™ exclusive partnerships enable higher enrollment with customized recruiting plans

Insight into ongoing trials to eliminate competing trials

Extensive prescreening of practice patients.

Support site chart review for newly diagnosed patients

Block Enrollment Strategy

Unparalleled access to ophthalmic patients

Pre-schedule Patients

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With Block Enrollment, a group of patients is scheduled before the trial start date through our exclusive OraNet™ site network

Enroll More Patients Per Site

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Using on-site personnel, we can enroll a large volume of patients over a short period of time

Reduced Data Variability

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Consistent patient evaluations, more focused investigators, and consistent staff across all sites lead to reduced data variability

Accelerate Your Timelines

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Conventional “rolling” enrollment draws out the process for months or even years
Block Enrollment can reduce your timeline by more than 35% and reduce costs

Minimize variability of data and get insights into how and when
enrollment numbers will be met – before your study even starts

Clinical Services

  • Turnkey global clinical trials conduct; resources from start-up to final deliverable
  • Customized programs based on your study design, geography and subject population. We provide all activities including medical monitoring, patient engagement, and technology-enabled services (e.g. Virtual Trials and Risk Based Monitoring)
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Clinical Trial Operations

  • Strategically situated across the globe to provide local geographic monitoring, for confidence that trials are conducted to the highest standards
  • Ora CRAs have an average of 5 years experience in ophthalmology and are assigned to studies based on their specific areas of expertise
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Monitoring

  • Seamless solutions utilizing industry-leading technologies such as SAS, iMednet, and Medidata
  • Expert biostatistics team delivers top-line analysis within 5 business days after database lock
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Biostatistics & Data Management

    • Preclinical, Regulatory, and CMC support
    • IP packaging, labeling, and distribution
    • CTMS and eTMF technologies
    • Quality oversight
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Additional Services

Empowering Real-Time Management and Reporting/Metrics

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    96%

    of Clinical Project Managers have 5+ years of experience in ophthalmology

96%

Track study start-up using key milestones available to you

  • Key process steps
    • IRB submission complete
    • First study site initiated
    • IP release approval
  • Key data
  • Greenlight process
  • Site feasibility, selection, and negotiation/ administration of contracts

Study enrollment: Right sites, right patients, at the right time

  • Strategic & efficient enrollment
  • Consistent site management
  • CTMS site compliance tracking

Study closeout

  • Timely database locks
  • Accountability of investigational product
  • Site quality audits
  • Clinical study report development

eTMF enables real-time, complete visibility into the TMF status

  • Integration with contracts, budgets, and protocol
  • QC review and approval for documents

CTMS: Ensure consistent momentum through unparalleled visibility & live updates across study duration

  • Align clinical supply with site initiation via milestone tracking
  • Assess progress on activities such as subject enrollment against goals
  • Confirm protocol adherence from anywhere
  • Reduce number of site visits with implementation of remote monitoring status to track and resolve issues as they arise
Study Start-up

Track study start-up using key milestones available to you

  • Key process steps
    • IRB submission complete
    • First study site initiated
    • IP release approval
  • Key data
  • Greenlight process
  • Site feasibility, selection, and negotiation/ administration of contracts
Conduct

Study enrollment: Right sites, right patients, at the right time

  • Strategic & efficient enrollment
  • Consistent site management
  • CTMS site compliance tracking

Study closeout

  • Timely database locks
  • Accountability of investigational product
  • Site quality audits
  • Clinical study report development
Systems

eTMF enables real-time, complete visibility into the TMF status

  • Integration with contracts, budgets, and protocol
  • QC review and approval for documents

CTMS: Ensure consistent momentum through unparalleled visibility & live updates across study duration

  • Align clinical supply with site initiation via milestone tracking
  • Assess progress on activities such as subject enrollment against goals
  • Confirm protocol adherence from anywhere
  • Reduce number of site visits with implementation of remote monitoring status to track and resolve issues as they arise

Tailored Medical and Clinical Monitoring Approaches

  • Safety oversight and strategic clinical guidance across all ophthalmic indications
  • Safety Management Plans with standard flow chart for SAE communication
  • Ongoing review of all adverse event listings
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Protocol Review

  • Our team works with you to develop flexible monitoring plans tailored to the specific needs of your study, geography, and patient population
  • Processes are designed with the end in mind – delivering quality data to support the registration of your product
  • We can implement solutions ranging from Traditional Monitoring with 100% on-site SDV to full Risk Based Monitoring
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Tailored Strategies

  • Ora’s RBM process helps assess, control, communicate and review the quality risks to drug products across the product lifestyle
  • Software solutions that use machine learning, along with classical statistical models to predict, detect, analyze, and manage risk
  • Partnership with ThoughtSphere for design, deployment, and management of RBM trials and Central Monitoring
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Risk Based Monitoring

  • Ora CRAs have an average of 5 years experience in ophthalmology and are assigned to studies based on their specific areas of expertise
  • Strategically located around the globe to provide local monitoring and reduce travel time
  • 70% of our CRAs have been with Ora for more than 2 years
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Staff & Experience

Expert Clinical Data Services

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EDC & DATA MANAGEMENT

Upholding the highest standards of data quality, integrity, and security

EDC & DATA MANAGEMENT

Upholding the highest standards of data quality, integrity, and security

  • Industry-leading EDC technologies providing real-time access to data, trends, and analytics
  • Creation of data management documentation: eCRF, aCRF, eCCG, DMP, and DVM
  • Robust ophthalmic eCRF and edit check libraries built by therapeutic experts
  • Constant, open communication with study team members and 24/7 EDC helpdesk

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BIOSTATISTICS

Experts in designing and analyzing ophthalmic clinical trials

BIOSTATISTICS

Experts in designing and analyzing ophthalmic clinical trials

  • Protocol input including sample size calculation, primary endpoint definition, and study design
  • Top-line analysis delivery 5 business days after database lock
  • CDISC and submission-ready data expertise including SDTM, ADaM, and Define.XML
  • Interim analysis, data monitoring committee (DMC), and safety review meeting support

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IRT

Interactive Response Technology (IRT) solutions for complex study needs

Device

Interactive Response Technology (IRT) solutions for complex study needs

  • Automated patient randomization
  • Inventory resupply based on triggers or predictive automation
  • Emergency field-level unmasking
  • Custom inventory status development
  • Product expiration management
  • 24/7 helpdesk and dedicated IRT project manager on your study team

Accelerate your product development with Ora

For over 40 years, Ora has been on the leading edge of ophthalmic product development. We have a track record for accelerating development timelines and have helped our clients garner over 50 FDA approvals. Let’s work together to move your program forward.

Copyright © 2020 Ora, Inc. All Rights Reserved.