CLINICAL TRIALS PROFILE FOR SYFOVRE

All Clinical Trials for syfovre

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06961370 ↗	A Study to Investigate Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Immunogenicity of RO7669330 in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)	RECRUITING	Hoffmann-La Roche	PHASE1	2025-07-16	The main purpose of this study is to assess the ocular and systemic safety and tolerability of RO7669330 in GA secondary to AMD after multiple unilateral intravitreal (IVT) doses.
NCT07160179 ↗	Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration	RECRUITING	AbbVie	PHASE1	2025-08-13	Age-related macular degeneration (AMD) is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. Geographic Atrophy (GA) is an advanced form of dry AMD. The purpose of this study is to assess the adverse events and how intravitreal ABBV-6628 moves through the body of adult participants with secondary to age-related macular degeneration ABBV-6628 is an investigational monoclonal antibody fragment being developed for the treatment of geographic atrophy (GA) secondary to (AMD) age-related macular degeneration. Participants in the Stage 1 part will be placed in 1 of 4 groups, called treatment arms. Participants in Stage 2 will be placed into 1 of 2 groups. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis GA secondary to age-related macular degeneration will be enrolled. Around 66 participants will be enrolled in the study at approximately 27 sites across the US. Participants in Stage 1 will be given ABBV-6628 as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection) with dose escalation. Participants in Stage 2 will receive ABBV-6628 or SYFOVRE, an approved treatment for geographic atrophy, administered as per the FDA-approved label. The treatment duration is approximately 22 months and 3 months of follow-up. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
NCT07214740 ↗	Study to Evaluate a Pegcetacoplan (Syfovre) Prefilled Syringe	NOT_YET_RECRUITING	Apellis Pharmaceuticals, Inc.	PHASE3	2025-10-01	This is a phase 3, open-label study to evaluate the safety of pegcetacoplan in a prefilled syringe (PFS)
NCT07215390 ↗	A Phase 2, Randomized, Placebo Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL 3007 in Combination With Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed With Geograph	RECRUITING	Apellis Pharmaceuticals, Inc.	PHASE2	2025-06-23	A Phase 2, Randomized, Placebo-controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL-3007 in Combination with Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed with Geographic Atrophy Secondary to Age-Related Macular Degeneration

Clinical Trial Conditions for syfovre

Condition Name

Condition Name for syfovre
Intervention	Trials
Geographic Atrophy	2
Geographic Atrophy Secondary to Age-related Macular Degeneration	2
Age-Related Macular Degeneration	2

Condition MeSH

Condition MeSH for syfovre
Intervention	Trials
Macular Degeneration	3
Geographic Atrophy	3

Clinical Trial Locations for syfovre

Trials by Country

Trials by Country for syfovre
Location	Trials
United States	13

Trials by US State

Trials by US State for syfovre
Location	Trials
Texas	2
Maryland	2
California	2
Indiana	1
Tennessee	1

Clinical Trial Progress for syfovre

Clinical Trial Phase

Clinical Trial Phase for syfovre
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
PHASE1	2

Clinical Trial Status

Clinical Trial Status for syfovre
Clinical Trial Phase	Trials
RECRUITING	3
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for syfovre

Sponsor Name

Sponsor Name for syfovre
Sponsor	Trials
Apellis Pharmaceuticals, Inc.	2
AbbVie	1
Hoffmann-La Roche	1

Sponsor Type

Sponsor Type for syfovre
Sponsor	Trials
INDUSTRY	4

Syfovre Market Analysis and Financial Projection

Last updated: February 12, 2026

What Is the Current Status of SYFOVRE’s Clinical Trials?

SYFOVRE (er NVIDIA) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Its approval was based on data from pivotal clinical trials, namely the Phase 3 DERBY and OAKS studies, which demonstrated a statistically significant reduction in GA growth rate compared to sham treatment.

Clinical Trial Details

• Phase: 3
• Trials: DERBY and OAKS
• Primary Endpoint: Reduction in GA progression
• Results:
  • Both studies showed a consistent reduction in GA growth rate.
  • SYFOVRE was well tolerated, with adverse events comparable to placebo.
• Approval: FDA approved in September 2023.
• Labeling: Approved for patients with GA secondary to AMD, with dosing every 24 weeks.

Ongoing and Future Trials

No publicly disclosed Phase 4 or post-marketing studies are currently registered for SYFOVRE. The focus appears to be on expanding approval to broader patient populations and long-term safety assessment.

How Is the Market for SYFOVRE Shaping Up?

Market Size and Segments

Age-related macular degeneration affects an estimated 200 million individuals globally, with geographical atrophy representing approximately 20% of dry AMD cases. The global AMD therapeutics market was valued at approximately $5 billion in 2022 and is projected to reach $9 billion by 2030, growing at a compound annual growth rate (CAGR) of 7 percent [1].

Key Market Drivers:

• Aging global population.
• Limited existing treatments for GA.
• Increasing awareness and early diagnosis.

Competitive Landscape

No approved therapies currently exist for GA outside of experimental or off-label use, notably intravitreal injections of complement inhibitors under clinical trials, such as:

• Pegcetacoplan (Apellis)
• Avacincaptad pegol (Iveric Bio)

SYFOVRE’s approval is expected to secure a first-mover advantage within the GA treatment segment. Its competitive edge is based on its dosing schedule (every 24 weeks) and safety profile demonstrated in trials.

Revenue Projections

Initial sales may range between $200 million and $400 million in the first 3 years post-launch, considering:

• Estimated eligible patient population in the U.S.: approximately 10 million with dry AMD.
• Assumed market penetration rate: 2-5% in the initial year, increasing with expanding indications.

International markets are expected to follow, with regulatory submissions in the European Union and Asia planned within 12 to 24 months.

Pricing Strategy

Pricing is anticipated to align with other intravitreal therapies, roughly $3,500 to $5,000 per injection, with the 24-week dosing schedule potentially offering cost advantages over monthly treatments.

What Are the Projections for SYFOVRE’s Market Performance?

Short-Term Outlook (2024-2026)

• Sales are expected to reach approximately $300 million by 2025.
• Market penetration will depend heavily on clinician acceptance and insurance reimbursement.

Long-Term Outlook (2027-2030)

• With expanded indications, including earlier-stage GA, revenue potential could exceed $1 billion globally.
• Entry into European and Asian markets could double the revenue estimate.

Risks

• Competition from other pipeline therapies.
• Slow adoption due to conservative treatment approaches.
• Potential safety concerns over long-term use.

Summary of Market and Trial Data

Parameter	Details
Approval Date	September 2023
Indication	Geographic atrophy secondary to AMD
Global AMD market size	~$5 billion (2022); projected ~$9 billion (2030)
Estimated eligible patients	10 million in the U.S.
Dosing schedule	24 weeks (quarterly)
Pricing estimate	$3,500–$5,000 per injection
Initial market share forecast	2-5% in first year
Long-term revenue potential	>$1 billion globally

Key Takeaways

SYFOVRE secures a significant position in a market with high unmet needs. Its approval introduces a new treatment option with a convenient dosing schedule and favorable safety profile. Market growth hinges on expanding indications, clinician acceptance, and global regulatory approval.

FAQs

1. When was SYFOVRE approved by the FDA?
September 2023.

2. What is the primary indication for SYFOVRE?
Geographic atrophy secondary to age-related macular degeneration.

3. How does SYFOVRE compare to other treatments in development?
Currently, no other FDA-approved therapies exist for GA. Pipeline treatments, like complement inhibitors, aim for similar or broader indications, but SYFOVRE’s quarterly dosing and safety profile provide competitive advantages.

4. What are the main barriers to market expansion?
Regulatory approval in international markets, clinician adoption, insurance reimbursement, and long-term safety data.

5. What is the projected revenue for SYFOVRE in the next five years?
Between $300 million and over $1 billion, contingent on market penetration and expansion strategies.

References

1. "Age-Related Macular Degeneration Market," MarketDataForecast, 2022.