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Retina & Macular Diseases

Three decades of Retina research. Proven models. Trusted results.

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New therapies. New modalities. Greater urgency. Retina & Macular Diseases are leading causes of vision loss and blindness worldwide.

With aging populations, rising incidences of hypertension and diabetes, and increasing rates of autoimmune disease, the need for novel therapies is greater than ever.

Illumination of the healthy retina

We’ve shaped our team to meet the moment.

For over thirty years, our team of Retina & Macular Disease specialists have successfully navigated the retinal research landscape — guiding clients across all phases of development to ensure the highest likelihood of clinical success. In the past 5 years alone, the Retina & Macular Disease team ran 135+ programs across all phases of the developmental pipeline. Our team of Retina & Macular Disease specialists will guide you through every step of the regulatory and approval process, ensuring a smooth and successful journey from start to finish.

Partner with Ora, the ophthalmology research company and get your best in class Retina & Macular Disease therapeutic to market.

Key Indications

Wet Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration
Geographic Atrophy
Diabetic Retinopathy
Diabetic Macular Edema
Retinal Vein Occlusion


Retinitis Pigmentosa
Leber Congenital Amaurosis
Ushers
Retinal Dystrophy
Stargardt Disease

The Ora Retina & Macular Disease Team Leaders

Keith Lane

Senior Vice President, 
Posterior Segment

20+ years’ experience in Retinal & Macular Disease pharmaceutical development

Expert in developing innovative endpoints and trial designs for retinal diseases, advancing clinical research methodologies in IRDs and FDA accepted mobility tests

Published extensively on retinal diseases and clinical trial advancements, including FDA-accepted mobility tests

Dr. Alex McKeown

Retina Specialist / Expert

PhD in vision science and retinal imagining techniques

10+ years in ophthalmology drug development and research, including at Apellis with key role getting first GA product approved by FDA as well as at Novartis and Heidelberg

Expertise in retinal image analysis, with prior roles as reader both for Duke and BIRC Reading centers

Ora Retinal & Macular Disease experience over the last 5 Years

1450 +

Patients enrolled

240 +

Sites activated

135 +

Programs

The Ora Retina & Macular Disease team’s comprehensive expertise spans early-phase clinical trials to late-stage studies. 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 Retina & Macular Disease pipeline choose to partner with Ora

Highly Specialized

50+ years experience as an ophthalmology exclusive CRO and over 30 years traversing the Retina & Macular Disease clinical research field.

Deep Retina & Macular Disease Experience

Leader in the retinal space with broad posterior indication experience and trial success. Key Retina & Macular Disease site relationships increase enrollment and start up efficiencies.

Proven & Streamlined Model

Intricate knowledge of the current operating model and team ensures rapid study start up and execution.

Relevant Regulatory & Surgical Experience

Our relationships with regulatory bodies and surgical experience with IVT and sub-retinal injections ensure no important detail is left out of your Retina & Macular Disease studies.

A sample of Ora successes
Expert end-to-end Retina & Macular Disease therapeutic pipeline highlights

A Diabetic Macular Edema (DME) drug approval in the United States in 2023 [innovative decoy receptor that binds VEGF-A], showcasing Ora’s ability to guide Retina & Macular Disease therapeutics from concept to approval.

Proven ability to accelerate enrollment in Retina & Macular Disease studies:

nAMD Phase 1 clinical trial completed enrollment two months ahead of schedule.
dAMD/GA Phase 2 program finished enrollment one month ahead of scheduled timeline.

The Ora Visual Navigation Challenge (VNC™) Mobility Course

The Ora-VNC™ was created to serve as a functional endpoint to evaluate cell and gene therapies (CGT) efficacy in treating inherited retinal diseases (IRDs).

Since the technology’s inception, the VNC™ mobility course has been used in 20+ clinical trials as a clinical endpoint.

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Key Features of the Ora-VNC™ Technology

1

Broad range of mobility courses to accommodate various types of vision loss and levels of severity.

2

Customizable to different difficulty levels to cater to a wide-variety of patient populations.

3

Incorporates a fully masked and independent reading center grading system for objective scoring of mobility test performance.

4

Designed for use in multi-center studies.

5

FDA accepted integral endpoint in IRD studies.