Dry AMD Market Set for Significant Growth Through 2034 as Novel Therapies Advance in Clinical Development
核心洞察
The dry age-related macular degeneration market is expected to experience substantial growth through 2034, driven by the uptake of recently approved therapies and the anticipated launch of emerging treatments.
Multiple innovative therapies are advancing through clinical trials, including Gildeuretinol from Alkeus Pharmaceuticals (搜索), which demonstrated a 0.25 sq mm per year reduction in geographic atrophy lesion growth compared to placebo in its Phase II/III SAGA trial.
The United States represents the largest market opportunity with approximately 21 million prevalent cases in 2024, while dry AMD accounts for nearly 90% of all AMD cases, representing a vast untapped therapeutic opportunity.
The dry age-related macular degeneration (AMD) market is poised for rapid expansion through 2034, fueled by an expanding treatment landscape that includes recently approved therapies and a robust pipeline of emerging treatments targeting this largely underserved patient population.
According to market analysis, the overall dry AMD market size in the United States is anticipated to increase significantly due to the uptake of recently approved therapies and the launch of emerging therapies such as Gildeuretinol (Alkeus Pharmaceuticals (搜索)), Tinlarebant (Belite Bio (搜索)), ANX007 (Annexon Biosciences (搜索)), JNJ-1887 (Johnson & Johnson Innovative Medicine), AVD-104 (Aviceda Therapeutics), OpRegen (Lineage Cell Therapeutics and Roche), OCU410 (Ocugen), and Elamipretide (Stealth BioTherapeutics (搜索)).
Market Size and Patient Population
The United States accounts for the largest market size of dry AMD compared to EU4 (Germany, Italy, France, and Spain), the UK, and Japan. Among the seven major markets (7MM), the US accounted for the highest prevalent cases of dry AMD in 2024, with around 21 million cases, and these cases are expected to increase during the forecast period.
Despite recent regulatory approvals, dry AMD remains a vast untapped market opportunity, as it accounts for nearly 90% of all AMD cases. The FDA has approved two therapies for dry AMD: IZERVAY (August 2023) and SYFOVRE (February 2023). In February 2025, the U.S. FDA expanded the label for Astellas' IZERVAY, authorizing its use for longer-term treatment of geographic atrophy.
Promising Clinical Trial Results
Several companies have reported encouraging clinical trial data for their investigational therapies. Alkeus Pharmaceuticals (搜索) recently completed its Phase II/III SAGA trial for Gildeuretinol, an investigational once-daily oral therapy currently being evaluated for geographic atrophy. In September 2024, the company reported that oral gildeuretinol acetate reduced GA lesion growth by 0.25 sq mm per year compared with placebo after 24 months. Further data released in May 2025 showed that patients receiving gildeuretinol experienced a slower decline in vision-related quality of life (VFQ-25) and functional reading independence (FRI) scores versus placebo over the same period.
Gildeuretinol is a chemically modified form of vitamin A designed to limit the buildup of toxic retinal by-products. Beyond geographic atrophy, the drug is also being studied for Stargardt disease.
Advancing Pipeline Therapies
Belite Bio (搜索)'s Tinlarebant represents another promising oral investigational therapy aimed at decreasing the buildup of toxic by-products in the retina that drive Stargardt disease type 1 and contribute to geographic atrophy. The company is conducting a global two-year Phase III PHOENIX study, a multicenter, randomized, double-masked, placebo-controlled trial evaluating tinlarebant's safety and efficacy in GA. In November 2023, the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) approved the PHOENIX trial.
Johnson & Johnson Innovative Medicine's JNJ-81201887 (formerly AAVCAGsCD59) represents a novel approach as a one-time gene augmentation therapy in development for geographic atrophy. The therapy is designed to elevate local expression of soluble CD59 (搜索) (sCD59), potentially reducing membrane attack complex (MAC) formation and protecting retinal cells from degeneration. The U.S. FDA has granted it Fast Track designation, and the European Medicines Agency has recognized it as an Advanced Therapy Medicinal Product (ATMP). The Phase IIb PARASOL trial is now enrolling adults aged 60 and older with advanced dry AMD and GA.
Regulatory Recognition and Recent Developments
ANX007 has achieved significant regulatory recognition, becoming the first therapeutic candidate for the treatment of geographic atrophy to receive PRIME designation in the EU, which provides early and proactive support to developers of promising medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options.
Recent developments in 2025 have highlighted continued innovation in the field. In February 2025, Cognition Therapeutics (搜索) reported a positive outcome of an analysis of masked data from the ongoing 'MAGNIFY' Phase II trial of zervimesine (CT1812) in adults with geographic atrophy secondary to dry AMD. The same month, Luxa Biotechnology (搜索) announced that the US FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RPESC-RPE-4W transplantation for the treatment of patients with dry AMD.
Market Drivers and Opportunities
Key factors driving market growth include the rising prevalence of dry AMD, with cases expected to increase by 2034, and emerging diagnostic technologies in ophthalmology. New diagnostic technologies such as spectral-domain OCT and fundus autofluorescence have emerged, giving ophthalmologists a better picture of the eye, which will aid in the confirmation of anatomic endpoints for geographic atrophy.
The anticipated launch of these emerging dry AMD therapies are poised to transform the dry AMD market landscape in the coming years. As these cutting-edge dry AMD therapies continue to mature and gain regulatory approval, they are expected to reshape the dry AMD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.