In 2019, the World Health Organization (WHO) released its World Report on Vision, finding that over 2.2 billion people worldwide were living with vision impairment or blindness. Due to factors such as the aging population, growing incidence of lifestyle diseases like type 2 diabetes, and population growth, the need for global eye care is projected to increase exponentially. In line with these trends, the global ophthalmic clinical trials market size was valued at US$1.5 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 6.6% between 2023 and 2030. In response to the increasing demand for ocular treatment therapies, partnering with ophthalmology CROs (contract research organizations) is becoming critical for sponsors to deliver novel ocular therapies to patients faster.

In this article, we explore the top 10 ophthalmology CROs to consider for your next ophthalmology clinical trial! 

1. Iris Pharma, a Specialized Ophthalmology CRO

Since its inception, Iris Pharma, a France-based ophthalmology CRO, has positioned itself at the forefront of both preclinical and clinical ophthalmology research services across the globe. A key measure of this ophthalmic CRO’s success is its track record of bringing over 70 ocular drugs and medical devices to market during its 34 years of operating in the field. These products span a variety of ocular indications, including glaucoma, dry eye, ocular inflammation, infection, and allergy. In addition to their expertise across all four phases of clinical trials in Europe, the United States, and North Africa, Iris Pharma also offers the following preclinical services: 

• In vivo pharmacology studies 
• Ocular tolerance, safety, and pharmacokinetic  
• Efficacy & proof-of-concept 
• Pilot tolerance & safety testing
• Formulation & delivery 

Most notably, the company has forged long-standing relationships with key opinion leaders (KOLs) in the field of ophthalmology, including renowned ophthalmologists and pharmacologists and well-established investigative sites, which enables them to consistently deliver successful international clinical trials. 

2. PPD (Part of Thermo Fisher Scientific)

PPD is Thermo Fisher Scientific’s clinical research business, and its dedicated Ophthalmology CRO unit is a leading provider of end-to-end drug development and study design capabilities in ocular diseases. Over the past five years, PPD Ophthalmology CRO’s experience includes more than 60 ocular clinical trials with 8150 ophthalmology patients and over 1850 experienced sites active globally.

With this background in developing drugs for several types of eye disorders, from acute optic neuritis to uveitis, PPD no doubt has a proven track record of success. Their achievements include reducing global site activation timelines by more than 30%, boosting enrollment by 25% on a dry eye study, and facilitating registration approval for numerous products. The PPD Ophthalmology team, supported by 300 clinical professionals and three board-certified ophthalmologists, can ensure your eye disease therapy moves from development to commercialization smoothly and efficiently.  

3. TFS HealthScience’s Ophthalmology CRO 

TFS HealthScience is a globally recognized CRO that covers various therapeutic areas, including ophthalmology. The company offers customized ophthalmic clinical research solutions that cater to the specific needs of each client, ensuring they receive the right resources and support required to succeed in their clinical trial. Notably, TFS HealthScience provides eye disease clinical trial sponsors access to a global network of experienced investigators through their Ophthalmology Elite Site Network. They also offer evaluation and input into project design, indication, and disease prevalence, all provided by internal ophthalmologists and via a KOL network. Among their full suite of services to support clinical trials are study protocol design and writing, full-service project management, regulatory affairs, clinical operations, medical monitoring, and many more.

Most recently, in January 2023, TFS HealthScience announced a strategic acquisition of Appletree CI Group, a specialized contract service organization (CSO) that stands in a category of its own as the only CRO in Europe to possess expertise in both medical devices and ophthalmology. This acquisition further strengthened TFS’s expertise in such a complex therapeutic area, solidifying its position as a top ophthalmology CRO. Visit the TFS Intellect Hub to learn more about the current landscape of ophthalmology clinical research.

Read this installment of our EmpowHER article series here to learn more about TFS’s Ophthalmology lead, Marcia Swank, Vice President of Ophthalmology at TFS HealthScience.  

4. Syneos Health’s Ophthalmology CRO

Syneos Health has established itself as a leading ophthalmology CRO by supporting the development and commercialization of nearly 50 approved therapies for eye disorders since 2016. Their ophthalmology team has extensive ocular scientific and therapeutic expertise, consisting of more than 500 clinical staff and nine expert ophthalmologists. As a testament to their capabilities, the Syneos ophthalmology team has successfully run over 100 ophthalmology clinical studies between 2016 and 2021. The company has also demonstrated its ability to manage studies of all clinical phases, including the execution of the largest-ever wet AMD registrational studies.

Given the patient recruitment challenges typically faced by ophthalmology clinical trials, sponsors can benefit from Syneos Health’s long-lasting relationships with ophthalmology investigators at almost 600 sites worldwide, many of which are members of their exclusive Ophthalmology Catalyst Site Network. Lastly, this ophthalmology CRO also provides Global Regulatory Affairs Solutions, ensuring a smooth journey from early development to post-marketing stages.  

5. Promedica International (PMI), a Specialized Ophthalmology CRO

Promedica International (PMI) is another company that has carved a niche for itself as a specialized CRO in the realm of ophthalmology clinical trials. PMI has extensive experience in managing ophthalmic devices, biotechnology, and pharmaceutical clinical research projects, which span from single-site studies involving less than 100 subjects to large, multi-center projects involving several hundred subjects.

They also maintain an extensive network of research ophthalmologists and KOLs specializing in cornea, retina, glaucoma, and general ophthalmology to guide the company’s ophthalmic clinical program development. Their broad range of clinical trial capabilities includes regulatory strategy consultation, early phase/safety studies, product registration studies, and more. Lastly, this ophthalmology CRO offers various services beyond clinical trials as well, such as project management, product development planning, and product commercialization, among others.  

6. ICON’s Ophthalmology CRO

As a global, full-service company, ICON Ophthalmology has been at the forefront of ophthalmology drug and device development, offering a complete range of leading solutions and services. These services include therapeutic expertise, medical monitoring, data support and verification, telemedicine/home nursing, patient recruitment and retention, and faster start-up and accelerated patient enrollment. As one of the largest CROs in the world, ICON Ophthalmology CRO’s product development track record totals 16 studies across 633 sites with 5709 patients over the last 5 years.

The company has demonstrated expertise in a range of ophthalmology areas, including age-related macular degeneration, cataracts, conjunctivitis, dry eye disease, glaucoma, and several more. Interestingly, ICON is also leading the way in the development of retina implant technology and digital devices, which are growing in importance in the fight against blindness. Their medical device project portfolio includes helping the development of intra-corneal inlay for the treatment of presbyopia, non-surgical vision restoration therapy software device, and a suite of novel devices to detect macular degeneration.  

7. Lexitas, a Specialized Ophthalmology CRO

Lexitas is a 100% ophthalmics-focused CRO that is designed to meet the niche needs of ophthalmology sponsors and develop treatments that have the potential to revolutionize eye care. Their team, made up of seasoned specialists, relationship builders, and ophthalmology experts, have years of expertise and first-hand experience in ocular studies. As a smaller ophthalmology CRO, Lexitas has the advantage of being able to take a personalized approach to service delivery. They use an integrated service model that is tailor-made to fit the unique requirements of each study, maximizing their effectiveness every time.

In addition to its deep expertise, personalized services, and expert guidance, Lexitas provides full-service solutions and support for indications ranging from posterior and anterior eye studies to rare diseases. Sponsors can benefit from their wide range of services, including Clinical Operations, Medical & Regulatory Writing, Medical Monitoring, and Biometrics. With these supports and their track record, Lexitas matches the same level of success and experience as those of larger ophthalmology CROs.

8. CROMSOURCE’s Ophthalmology CRO 

CROMSOURCE is another top CRO with a dedicated ophthalmology unit that has a wide global reach rooted in their headquarters in both Europe and the United States, providing their expertise capabilities in regions including the Middle East, Africa, APAC, and South America. CROMSOURCE’s dedicated Ophthalmology CRO is not only experienced in data collection but also in understanding how ophthalmology sites operate, as well as how to manage and support them effectively for rapid recruitment and high-quality data. The company’s knowledge of ocular disease indications ranges from retinitis pigmentosa and dry eye to macular degeneration and glaucoma.

Most notably, what establishes CROMSOURCE among the top ophthalmology CROs is their “End-to-End Guarantee” for clinical trials, where sponsors are guaranteed agreed upon study startup time, enrollment, price with no CRO-initiated Change of Scope, and date for Database Lock. Their Feasibility Plus™ and One Trial One Price™ programs function to back up these guarantees, with CROMSOURCE also writing these into their contracts with clients. With their extensive experience, wide service portfolio, and unique guarantees, CROMSOURCE no doubt stands as a top choice for ophthalmology clinical trial sponsors.  

9. Medpace’s Ophthalmology CRO

Medpace is one of the most well-recognized CROs in the world and their dedicated Ophthalmology CRO has proven to be able to navigate the complexities of ocular disease studies from Phase I-IV. The company’s cross-functional teams are made up of ophthalmology-specialized clinical trial managers and program coordinators, while their leadership includes in-house, board-certified ophthalmologists and gene therapy specialists who contribute strong medical and scientific expertise.

Since its founding, clinical trial sponsors, both small and large, have trusted Medpace to lead their ophthalmology product development programs across several indications. Their experience in eye diseases covers indications such as age-related macular degeneration (AMD), cataracts, diabetic macular edema, inherited retinal disease, and many more. This ophthalmology CRO also offers a robust support team to guide pharmaceutical and biotech companies through global regulatory submissions and regulatory affairs to maintain the strictest compliance with industry standards around the world.

10. Trial Runners, a Specialized Ophthalmology CRO 

Last, but certainly not least, Trial Runners is a specialized ophthalmology CRO that has successfully led several clinical trials across a variety of indications in the field of ophthalmology, from early phase to phase II research. These indications include, but are not limited to, achromatopsia, AMD, dry eye disease, glaucoma, and uveitis. Another crucial piece in the successful track record of Trial Runners is their comprehensive service offerings, which span from project management and monitoring to drug safety and medical writing. Given their complete focus on ophthalmology alone, Trial Runners is yet another top choice among ophthalmology CROs for sponsors to consider for their next ocular disease study. This unwavering dedication to the field is evidenced in their extensive experience of running over 70 clinical trials.

Lastly, the company also supplements its staff of experts with the right tools to ensure sponsors’ efficiency and smooth trial operations from start to finish; these include professional electronic source solutions (eSource), affordable risk-based management strategies, and streamlined patient recruitment services via its in-house STRIDE program (Strategic Targeted Recruitment and Innovative Digital Engagement). 

Conclusion 

In conclusion, the landscape of translational ophthalmology research is experiencing an exciting shift in innovation to deliver novel solutions to debilitating eye diseases. This demand for new ocular therapies is partially responsible for driving the growing ophthalmic clinical trials market, which underscores the need for strong partnerships between sponsors and reliable ophthalmology CROs. The top 10 ophthalmology CROs discussed here, including Iris Pharma, PPD, TFS HealthScience, and others, each offer comprehensive services and have a proven track record in the field. With their expertise, resources, and long-standing relationships with KOLs and investigative sites, every one of these organizations stands out for their commitment and contributions to ophthalmology research. 

About TFS HealthScience CRO 

TFS HealthScience is a global CRO with an established foothold in oncology and hematology clinical research. Our team of clinical experts supports biotechnology and pharmaceutical companies throughout their entire clinical development journey with ophthalmology clinical trials. Visit our dedicated Ophthalmology CRO website to learn more about the expertise TFS can offer for your next cancer clinical trial, or connect with a TFS representative today!