Allergy

For over 30 years, Ora has been accelerating the pace and improving the quality of allergy research worldwide, earning our clients 19 FDA product approvals along the way.

19 FDA product approvals
including the last two NDAs for Lastacaft and Pazeo
Ora Japan, K.K.
We are now able to offer Japanese companies locally conducted, rapid Proof-of-Concept studies, as well as Phase 3 efficacy and safety programs.

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Paul Gomes, MS

Paul Gomes, MS
Vice President of Allergy Research
Preclinical Allergy Models

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Indication Preclinical Model
Allergy
  • 48/80 (rabbit)
  • Short Ragweed Sensitization (mouse)

Ora's success is based on a foundation of scientific rigor applied to the drug development process. We have created many proprietary clinical models and protocols that produce high-integrity safety and efficacy data quickly. To catalyze continuous innovation, we dedicate considerable resources to understanding ophthalmic clinical research design, model innovation and evolution, endpoint development and evaluation, clinical trial processes, and management strategies. The advantages we offer our Sponsors are in no small part derived from Ora's unique culture, what we call "The Ora Way," which promotes operational excellence, aggressive project management, creative study design and implementation, personal accountability, outcome-focused decision making, and close involvement of technical experts on day-to-day issues.

Paul Gomes, MS, Director, has accrued 13 years of experience in successfully executing allergy programs and clinical-regulatory strategy. As Director of the Allergy Department at Ora, Paul's responsibilities include regulatory interface, protocol/model development, clinical program management, and data interpretation, and he has overseen over a hundred allergy clinical trials. Paul has published numerous articles on specific drugs and on allergic conjunctivitis. Under his supervision, six different allergic conjunctivitis clinical programs have been approved by regulatory bodies. Mr. Gomes's core staff includes ophthalmologists, optometrists, PhD's, and experienced clinical trial managers.

We are the only allergy group in the world with a dedicated Ora-CAC team of more than 15 full-time professionals surrounded by our internal cross-functional teams in education, quality assurance and quality control, recruiting, and regulatory affairs. Together, these experts run the Ora-CAC Model System repeatedly throughout the year. This year, Ora conducted its 500,000th Ora-CAC in the field of allergy research.

Ora's Allergy Models

Pathophysiology of allergic reaction targeted Types of endpoint assessments Screening Agents/Classes
The Original Ora-CAC™ Early Phase CAC Titration and confirmation CACs
  • Anti-histamines
  • Vasoconstrictors
Environmental Hybrid CAC™ Early phase and late phase
  • Environmental diaries (CAC can be integrated)
  • Rhino- conjunctivitis
Screening CACs then enrollment in environmental phase
  • Anti-histamines
  • Mast cell stabilizers
Enviro-CAC™ Early phase and late phase
  • Environmental diaries (CAC can be integrated)
  • Rhino- conjunctivitis
  • Screening CAC, run-in period, then enrollment in environmental phase
  • Selection of treatment failures
Anti-inflammatories
Late Phase Repeated CAC™ Early phase and late phase Multiple CACs in series Titration and confirmation CACs Steroids
Zero Order Kinetic Micro CAC™ Late phase Multiple CACs in series Titration and confirmation CACs
  • Steroids
  • Anti-inflammatories
Allergen Biocube™ Early phase and late phase (Rhinitis)
  • Rhinitis endpoints in chamber
  • Objective Ora scale for nasal inflammation score (using nasal endoscope)
Priming visits
  • Anti-histamines
  • Anti-inflammatories
  • Immunotherapy
  • Steroids
CAC/Controlled Adverse Environment (CAE) – Allergy/Dry eye model
  • Early phase and late phase
  • Breakdown of epithelial barrier function
  • CAC
  • Ocular surface dry eye related endpoints
  • Co-morbidity of dry eye and allergy
  • CAC and CAE
  • Specific selection of patients who have compromised ocular surface that exacerbates CAC
  • Agents that provide barrier effect
  • Agents targeted at epithelium and integrity of ocular surface
  • Anti-inflammatories