Written By: Zaiba Malik, MD, Medical Director and Tracy Huiet, MS, Executive Director, Clinical Trial Management
The field of ophthalmology has long been dedicated to restoring and preserving vision, recognizing sight as one of humanity’s most valuable assets. However, clear and enduring sight is a challenge for individuals struggling with hereditary and age-related retinal diseases. These conditions are often rooted in the complex genetic make-up of the eye, and can lead to progressive vision loss, and eventually lead to blindness. New developments and the growing ophthalmology clinical development market offer the community hope for new treatments. Conducting ophthalmology clinical trials is complex and requires strong collaboration between the CRO and Sponsor to meet timelines and efficiently execute the trial.
Trends in Ophthalmology Clinical Development
Industry Trends
Ophthalmology is a growing therapeutic area in clinical development, reflecting the advancements and increasing focus on developing solutions for retinal diseases. According to Grand View Research, “The global ophthalmic clinical trials market size was valued at USD 1.5 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 6.6% from 2023 to 2030,” 1 and according to Global Market Insights, the ophthalmology CRO market alone is estimated to grow with a CAGR of 7.3% by 2032.2
Key growth factors are the increased prevalence of eye disease, the increasing demand for ocular treatment, and increasing research funding in the area. According to J.P. Morgan, $588 million in seed and Series A rounds focused on ophthalmology in 2023, which was third in the top therapeutic areas, following cancer and neurologic.3 This investment into emerging biotechs drives innovation and offers hope in the ophthalmology space.
Trends in Retinal Diseases
According to Precedence Research, “By disease, the retinal disorder sector will have a bigger market share in the upcoming years and this segment formerly dominated the market with a share of around 34% in terms of revenue.”4
Ophthalmology as a field has always valued innovation. From cataract lens implants to glaucoma micro incisional surgery, to intravitreal injections, ophthalmologists are always looking to provide safer and more precise treatment to their patients. Retinal images provide remarkable understanding of disease pathology and thus a clear marker for endpoints and progression of disease activity. The burden of common diseases like age-related macular degeneration (AMD) and diabetic retinopathy are expected to exceed 400 million patients per year worldwide.5 The interest in gene therapy has been pushed forward with the approval of Luxtura and now the concept of “one and done” treatments continue to push research interest.
In terms of ophthalmic clinical trials, the retina segment continues to account for the large revenue share. Over 450 global companies have at least one ophthalmology drug program in Preclinical-Phase II and of those programs, the top 20 indications were largely retinal diseases, including age-related macular degeneration, diabetic macular edema, diabetic retinopathy, retinitis pigmentosa, retinal vein occlusion, and Stargardt’s.6
Medpace – A Leading Ophthalmology CRO
With recent and promising advances in ophthalmology clinical trials, Medpace’s deep experience in research in retinal diseases is beneficial for Sponsors. We have a broad range of expertise in retinal diseases, including but not limited to Inherited retinal diseases: retinitis pigmentosa, Stargardt’s, and Lebers, as well as diabetic retinopathy and macular degeneration.
While Medpace has a scientifically driven approach to clinical development, we are a full-service CRO with strong collaboration and efficiencies. This allows us to be one vendor that is a true extension of the Sponsor study team, including integrated services such as wholly-owned Central Laboratories and a Clinical Trial Management System that ties all study data together in a single platform. As a global mid-size CRO, our project teams are actively involved throughout the lifecycle of the project, and we can build close relationships and provide a personal touch, which fosters long-term partnerships with Sponsors of all sizes, including small biotech companies. Medpace’s mission is to accelerate the development of safe and effective medical therapeutics. To accomplish this, we allow Sponsors to rely on the experience and expertise our study team brings to ophthalmology clinical research.
Our Sponsors appreciate our work and value our expertise in ophthalmology and clinical development in general. Sometimes what we consider as “part of the job” comes across as above and beyond to our Sponsors. For example, the feedback Medpace provides during protocol reviews, a common task for us, is considered as helpful to Sponsors when finalizing protocol for FDA preIND meetings, especially when the Sponsor has no Ophthalmologist on staff.
“Based on my more than 20 years of experience working with many CROs, I would say that Medpace is truly one of the best. They are highly motivated with a strong can-do attitude. They always deliver on Sponsor requests with speed and quality as the first priority – not the paperwork – and that really differentiates Medpace from other CROs. We work together as one team toward the same goal.”
– Victor Shi, SVP, Chief Medical Officer, Valo
The growth of the ophthalmic clinical trial market and the anticipated discovery of novel ocular products is supported by the increasing partnerships between pharmaceutical companies and CROs.2 In this dynamic landscape, Medpace is a trusted ally to Sponsors offering expertise and guidance, as well as the comprehensive knowledge of the ophthalmology clinical development process. Strong partnerships between the Sponsor and CRO lead to a streamlined clinical development process, ultimately leading to an accelerated path to approval.
Ophthalmology CRO
Accelerating Complex Ophthalmology Clinical Trials with Specialized Expertise
Accelerate your path to approval with guidance from our team of ophthalmology-focused medical, operational and regulatory experts. Our extensive experience, world-class expertise, and consistent track record of success ensure the flexibility to adapt to the unique needs of each ophthalmology trial, overcome complex challenges, and keep trials on time and on budget.
References
- Grand View Research. Ophthalmic Clinical Trials Market Size & Share Report, 2030 ↩︎
- Global Market Insights. Ophthalmology Contract Research Organization (CRO) Market Size. Published September 2023. ↩︎
- J.P. Morgan. 2023 Annual Biopharma Licensing and Venture Report. Published December 2023. ↩︎
- Precedence Research. Ophthalmic Drugs Market. Published July 2023. ↩︎
- Market Scope. 2022 Retinal Pharmaceuticals Market Report: Global Analysis for 2021 to 2027. Published August 2022. ↩︎
- Citeline. Pharmaprojects: Therapeutic Area is Ophthalmology and Trial Status is Planned or Open. January 2024. ↩︎