The Overview
Science Corporation's PRIMA, a subretinal implant and specialized glasses combination, demonstrated durable, long-term vision gains in patients with geographic atrophy (GA) in the pivotal PRIMAvera study. At 36 months, patients saw an average improvement of 29 letters on an eye test chart, up from 24.5 letters at 12 months. The device also showed a favorable safety profile, with no new serious adverse events attributed to PRIMA between 12 and 36 months. PRIMA is currently available in Europe and the UK and is under regulatory review by the FDA in the US for GA linked to age-related macular degeneration.
Knolens Analysis
At a Glance
| Indication | Geographic Atrophy |
| Company | Science Corporation |
| Trial Phase | Phase 3 |
| Trial Acronym | PRIMAvera |
| NCT ID | NCT04676854 |
| Category | Clinical Trial Event |
| Sub Category | Topline Results Positive |
| Therapeutic Area | Others |
| Follow-up Duration | 36 months |
| Vision Improvement (36 Months) | 29 letters |
| Patients with >=15 Letter Improvement | 14 out of 18 |
| Regulatory Review Status (US) | Under review |
| Approved Markets | Europe, UK |
| Conference Name | EURETINA Congress of European retina specialists |
| Conference Date | October 1-4, 2026 |
| Regulatory Agency | FDA |
| Global Ophthalmic Devices Market Outlook | $15 billion by 2035 at 4.7% CAGR |
Science Corporation's PRIMA Shows Durable Vision Gains in GA
Science Corporation's PRIMA, a subretinal implant and specialized glasses combination, demonstrated durable, long-term vision gains in patients with geographic atrophy (GA) in the pivotal PRIMAvera study. At 36 months, patients saw an average improvement of 29 letters on an eye test chart, up from 24.5 letters at 12 months. The device also showed a favorable safety profile, with no new serious adverse events attributed to PRIMA between 12 and 36 months. PRIMA is currently available in Europe and the UK and is under regulatory review by the FDA in the US for GA linked to age-related macular degeneration.
- Significant and Durable Vision Improvement: The PRIMAvera study revealed that patients using Science Corporation's PRIMA device achieved an average improvement of 29 letters on a standard eye test chart at the 36-month mark, a notable increase from 24.5 letters at 12 months. Furthermore, 14 out of 18 efficacy-evaluable patients experienced improvements of at least 15 letters, while their natural vision remained stable, indicating robust and sustained efficacy.
- Favorable Long-Term Safety Profile: The study reported no new safety signals linked to the PRIMA device combination between the 12 and 36-month timepoints. Serious adverse events primarily occurred within the first six months post-surgery, and none of the three adverse events observed after 12 months were attributed solely to PRIMA, reinforcing its long-term safety.
- Regulatory Progress and Market Presence: PRIMA is already available to patients in Europe and the UK, specifically indicated for geographic atrophy linked to age-related macular degeneration. Science Corporation is actively pursuing US market approval, with the device currently under regulatory review by the FDA, positioning it for broader patient access.
Frequently Asked Questions
What is the best treatment for geographic atrophy?
The current best treatments for geographic atrophy (GA) are complement inhibitors, specifically pegcetacoplan (Syfovre) and avacincaptad pegol (Izervay). These intravitreal therapies target the complement cascade to slow the progression of retinal cell death and preserve vision. While they do not restore lost vision, clinical trials have demonstrated their efficacy in reducing the rate of GA lesion growth.
What is the average age of someone with geographic atrophy?
Geographic atrophy (GA) is a late-stage manifestation of age-related macular degeneration (AMD) that predominantly affects older adults. The average age of individuals diagnosed with GA typically falls within the mid-to-late 70s to early 80s. Prevalence increases significantly with advancing age, with a notable rise after 75 years.
How serious is geographic atrophy?
Geographic atrophy (GA) is a serious, progressive form of dry age-related macular degeneration (AMD) characterized by irreversible degeneration of retinal pigment epithelial cells, photoreceptors, and choriocapillaris. This leads to expanding areas of atrophy in the macula, resulting in significant and permanent central vision loss that severely impacts daily activities and quality of life. While new complement-inhibiting therapies offer the first opportunities to slow lesion growth, GA remains a leading cause of blindness in older adults, with no current treatment to restore lost vision.
Can geographic atrophy be stopped?
Geographic atrophy (GA) cannot currently be stopped or reversed. However, recent therapeutic advancements have introduced treatments designed to slow its progression. These complement-inhibiting therapies significantly reduce the rate of GA lesion growth, aiming to preserve vision for a longer duration.
What are the treatment guidelines for geographic atrophy?
Treatment guidelines for geographic atrophy (GA) have recently evolved with the approval of complement inhibitors. Pegcetacoplan (Syfovre) and avacincaptad pegol (Izervay) are intravitreal injections targeting the C3 and C5 components of the complement cascade, respectively. These therapies are indicated for slowing the progression of GA by reducing lesion growth, rather than restoring lost vision. Clinical decisions involve assessing lesion size, location, and progression rate, alongside patient factors.
Can geographic atrophy be treated?
Until recently, there were no approved treatments for geographic atrophy (GA). In 2023, the FDA approved two complement inhibitors, pegcetacoplan (Syfovre) and avacincaptad pegol (Izervay), for the treatment of GA. These intravitreal therapies target components of the complement cascade to slow the progression of retinal cell death. While they do not restore lost vision, clinical trials demonstrated a significant reduction in the rate of GA lesion growth.
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