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ENDPOINTS & TECHNOLOGIES

Ora R&D
Ora CAE®

IVAD

OPI 2.0©

Ora EyeCup™
Lissamine Green

Allergen BioCube®

Ora-CAC®
Ora-VNC™

Here’s how we develop testing

With our own in-house Research and Development (R&D) team, Ora believes in our continual evolution to match the best endpoints for each potential therapy.

 

Historically used endpoints and clinical designs often lack precise control of confounders. As a result, such studies are subject to more “noise” which increases sample size requirements or have low sensitivity to changes within early-stages of the disease. Ora R&D is on a quest for constant improvement of clinical endpoints and approaches to ensure we:

 

• Accurately measure product efficacy

• Fully understand the therapeutic impact

• Streamline clinical designs and sample requirements 

 

Ora R&D

Controlled Adverse Environment structure in front of green to red texture

At Ora, we do research on clinical research to optimize and enhance our sponsors’ future clinical trials. When your product has promise, let’s prove it.

  • With our own in-house R&D team, Ora believes in the continual evolution of our technologies and methodologies to match the best endpoints for each potential therapy.

  • The goal of the Ora R&D team is to turn down the noise in our sponsor’s clinical data to improve statistical power, increase likelihood of success, and give better therapy-placebo differentiation.

For more detailed information please download our one-pager.  

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Ora CAE®

Controlled Adverse Environment structure in front of green to red texture

The Ora Controlled Adverse Environment (CAE®) minimizes influential factors by standardizing temperature, humidity, airflow, lighting, and visual tasking. By creating a constant and reproducible challenge, CAE® offers industry leading precision with fewer patients, fewer sites, and less time.

  • The Ora CAE® technology provides controlled environmental stress that creates a consistent and replicable patient response. CAE® turns down the noise in our sponsor’s clinical dataset to improve the power of their novel therapeutic study.

  • Ora Controlled Adverse Environment (CAE®) is accepted by the FDA for Phase 2 and 3 studies as a primary endpoint in the US.

For more detailed information please download our one-pager.  

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IVAD

Ora’s IVAD (Inter-blink Interval Visual Acuity Decay) technology provides a clinically relevant, endpoint measurement of visual function. Thus, providing our sponsors with an innovative way to demonstrate therapeutic impact on ocular surface degradation. 

  • The Ora IVAD test is a novel diagnostic tool developed by researchers at Ora R&D to demonstrate the objective therapeutic benefit of visual function improvement in a clinical trial.

  • The IVAD test has been validated by Ora as a secondary endpoint in the US, Europe, and Latin America.

For more detailed information please download our one-pager.  

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OPI 2.0©

The Ora Ocular Protection Index 2.0 System© and the associated algorithm-run analysis provide a precise and novel measurement of the tear film breakup phenomenon and a functional endpoint in a clinical trial. 

  • The Ora OPI 2.0 system is a more clinically relevant measure of tear film instability. We provide quantitative (TFBUT) measurements as well as qualitative (mean surface breakup area), providing stronger data sets for our partners.
 
  • The Ora OPI 2.0 system can evaluate ocular surface protection under normal visual conditions. The new approach allows a more advanced method to analyze tear film dynamics.
 
  • Ora’s Ocular Protection Index (OPI) has been validated as a secondary endpoint in the United States.

For more detailed information please download our one-pager.  

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Ora EyeCup™

The Ora EyeCup™ technology powered by SDC Capture strengthens the quality of ophthalmic clinical studies, offering a comprehensive solution for capturing patient data and enhancing the overall research process. The user-friendly system captures high-quality clinical data and improves the likelihood of clinical study success.

  • The Ora EyeCup™ broadens your company’s data collection landscape both inside and outside of the clinic to reduce variability and produce more robust and higher quality data.

  • Use of the Ora EyeCup™ increases the number of data points obtained in a clinical trial in a shorter timeframe, bringing therapies to market more quickly and efficiently.  

For more detailed information please download our one-pager.  

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Lissamine Green

At Ora, the use of Lissamine Green (LG) helps illuminate the entire story of the anterior segment, providing crucial insight into the health and integrity of the conjunctiva.

  • LG staining exhibits greater consistency than the Sodium Fluorescein across multiple visits, suggesting it can serve as a reliable primary indicator for assessing Dry Eye Disease.
     
  • LG diagnostic staining has been validated by Ora as a secondary endpoint in the US, Europe, and Latin America.

  • Ora R&D is creating a new and more insightful grading scale for LG in the conjunctiva.  

For more detailed information please download our one-pager.  

Download Document

Allergen BioCube®

Ora’s state-of-the-art mobile Allergen Biocube® (mABC) is an environmental exposure unit that delivers pollen safely and uniformly to patients to induce the signs and symptoms al allergic conjunctivitis and allergic rhinitis identical to the real-world setting.

  • The combination of the uniform pollen delivery system in the mABC with the precise standardized individual allergy sign and symptom severity scales reduce data variability associated with environmental trials leading to a lower required sample size, fewer sites, and a more robust data set.

  • The mABC is accepted by the FDA as a primary endpoint in clinical trials in the United States. Additionally, the endpoints are adaptable based in the indication studies (allergic conjunctivitis, allergic rhinitis, or asthma).

Ora-CAC®

For over 40 years, the Ora conjunctival Allergen Challenge Model (Ora-CAC®) has been used to evaluate every anti-allergic agent for the treatment of allergic conjunctivitis. For the majority of these programs, Ora-CAC® Model studies were pivotal for the FDA approval of the drug.

  • Allergy is a highly variable condition, while environmental studies continue to be used for the assessment of anti-allergic agents, the precision of the Ora-CAC® model study design allows for a more predictive and rapid study, with fewer patients, fewer sites, and a tighter dataset.

  • The Ora-CAC® model incorporates validated severity scales (accepted by regulatory agencies around the world) to grade the signs and symptoms of ocular allergy. The model study design can be modified to better suit the MOA of your anti-allergic therapeutic candidate.

Ora-VNC™ mobility courses

Ora designed the Visual Navigation Course (VNC™) to assess mobility and functional vision in patients with inherited retinal diseases (IRD). The VNC™ also enables the clinically meaningful assessment of visual function through patient immersion in a 360-degree visual challenge environment.

  • The Ora VNC™ is highly adaptable as no single course is appropriate for all IRDs. Some IRDs are characterized by central vision loss (Leber’s Hereditary Optic Neropathy), some by light perception loss (Leber’s Congenital Amaurosis), and others by peripheral vision loss (Retinosa Pigmentosa). We modify the VNC™ to best suit the IRD your therapeutic is designed to treat.

  • Ora’s mobility courses have been presented to the FDA as integral endpoints in gene therapy, oligonucleotides, RNA therapy, and medical device development programs. The Ora VNC™ has been accepted by the FDA as a primary endpoint in the United States.

Ora-VNC™ mobility courses

Ora designed the Visual Navigation Course (VNC™) to assess mobility and functional vision in patients with inherited retinal diseases (IRD). The VNC™ also enables the clinically meaningful assessment of visual function through patient immersion in a 360-degree visual challenge environment.

• The Ora VNC™ is highly adaptable as no single course is appropriate for all IRDs. Some IRDs are characterized by central vision loss (Leber’s Hereditary Optic Neropathy), some by light perception loss (Leber’s Congenital Amaurosis), and others by peripheral vision loss (Retinosa Pigmentosa). We modify the VNC™ to best suit the IRD your therapeutic is designed to treat.

• Ora’s mobility courses have been presented to the FDA as integral endpoints in gene therapy, oligonucleotides, RNA therapy, and medical device development programs. The Ora VNC™ has been accepted by the FDA as a primary endpoint in the United States.

For more detailed information please download our whitepaper.  

Download Whitepaper

Ora-VNC™ mobility courses

Immerses patients in a 360-degree visual challenge environment that helps measure therapeutic impact by assessing improvements in patients’ functional mobility. 

 

• Customizable to different difficulty levels to cater to a variety of patient populations and conditions

 

Take your practice to the next level with Ora.

With turn-key support systems in place, Clinical research gives you the opportunity to grow your practice and make a difference to those who matter most — patients.

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For over 45+ years, Ora has been on the leading edge of ophthalmic product development.

When your product shows promise, let's prove it.

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