Inflammatory & Autoimmune
Elevating the standards of research with efficient processes, global logistics, and expansive site network—a system proven to deliver success.
Navigating complexity in Inflammatory & Autoimmune trials with precision and speed.
Inflammatory & Autoimmune diseases like Uveitis and Thyroid Eye Disease (TED) are major causes of vision impairment worldwide. If left untreated, the indications can lead to chronic pain, irreversible damage, and eventual blindness.
Current therapies often rely on corticosteroids or immunosuppressants with severe side effects, with no long-term guarantee for disease management. Sponsors are urgently pursuing biologics, gene therapies, and regenerative treatments that offer safer, more targeted, and longer-lasting solutions for patients.
With 30+ years in Inflammatory & Autoimmune research, Ora has led 5+ programs across multiple phases in just the last five years. Our approach blends expert regulatory strategy, deep site relationships, and tailored recruitment plans—ensuring each program has a streamlined path to market.
The Ora team is ready to turn world class research into real world impact.
By partnering with Ora, the ophthalmology research company, your program will receive expert and experienced based insight to give your Inflammatory & Autoimmune treatment the competitive edge to be first to market.
Key Indications
Thyroid Eye Disease
Uveitis
The Ora Inflammatory & Autoimmune Disease team leaders
Keith Lane
Senior Vice President, Posterior Segment
20+ years’ experience in challenging ophthalmic disease pharmaceutical development
Expert in developing innovative ophthalmic disease endpoints and complex trial design, advancing clinical research methodologies in IRDs and FDA accepted mobility tests
Published extensively on ocular diseases and clinical trial advancements, including FDA-accepted mobility tests
George Ousler
Therapeutic Area Head
20+ years’ experience in dry eye product development
Expert in clinical models and regulatory pathways, contributing to FDA-approved therapies like Xiidra®, TrueTear™, Tyrvaya®, and VEVYE®
250+ publications, owner of several patents, and world-renowned speaker on dry eye research and innovative breakthroughs
Ora Inflammatory & Autoimmune therapeutic and device experience over the last 5 years
Patients enrolled
Sites activated
Programs
The Inflammatory & Autoimmune Disease team’s comprehensive expertise spans early-phase studies to late-stage clinical trials. Our strategic regulatory guidance and efficient operational execution, ensures seamless trial progression through even the most complex development pathways.
Why Sponsors with therapies in the Inflammatory & Autoimmune pipeline choose to partner with Ora
A sample of Ora successes
Proven ability to accelerate enrollment timelines
Enrolled two patient populations in a global phase 2 thyroid eye disease (TED) trial early by 1.5 and 3 months respectively (naïve vs. treatment experienced).
Proven ability to accelerate enrollment in a phase 2a active non-infectious Uveitis (NIU) trial one month ahead of schedule despite the inherent complexities of active NIU studies.
Calculated Site Selection Accelerated Global Phase 2 TED Trial Enrollment
Ora’s team worked with the Sponsor to identify private practices and sites with large referral networks to hit and exceed activation timelines. Additionally, we communicated to sites their targeted activation dates at least a month prior to actual start-up. As a result, sites were able to pre-screen subjects early to stay on the sponsor’s record TED recruitment timeline.
Treatment naïve patient population
- 26 Patients completed enrollment
- 1.5 Months
Experienced patient population
- 15 Patients completed enrollment
- 3 Months early
Key Inflammatory & Autoimmune study execution success factors
Private practice sites chosen to accelerate naïve population recruitment
Sites with large referral networks were selected for treatment experienced population to accelerate enrollment.
Pre-screening and a detailed recruitment plan enabled rapid site activation and patient enrollment.
Trial-specific summary tool of key eligibility criteria allowed sites to focus in on ideal TED candidates and accelerated enrollment.
Global operations success factors across US, UK, Spain
KOLs ophthalmic networks and site selection
Focused site and patient engagement
“One Team” mentality with sponsor
Risk/Issue identification mitigation and escalations