Alcon Valeda™
Light Delivery System
The first and only FDA-authorized treatment for dry AMD to improve vision. Non-invasive photobiomodulation therapy for early and intermediate dry age-related macular degeneration.
The Dry AMD Market
Age-related macular degeneration (AMD) is the leading cause of blindness in developed nations. Approximately 11 million people in the United States have AMD, and dry AMD accounts for 85-90% of all cases. Globally, nearly 200 million people are affected, a number projected to grow to 288 million by 2040 as the population ages.
For decades, the standard of care for dry AMD has been limited to AREDS vitamin supplements and lifestyle modifications — a "watch and wait" approach that offers patients no meaningful treatment to improve their vision. This represents a massive unmet medical need and a significant market opportunity.
The Treatment Revolution
Until recently, the only FDA-approved treatments for any form of dry AMD were complement inhibitors (Syfovre, Izervay) — intravitreal injections that only treat geographic atrophy (advanced dry AMD) and only slow progression. They do not improve vision. Valeda changes everything by treating early and intermediate dry AMD and actually improving visual acuity.
Introducing Valeda™
The Alcon Valeda™ Light Delivery System is a revolutionary, first-of-its-kind photobiomodulation (PBM) device that represents a paradigm shift in the management of dry AMD. Authorized by the FDA through the De Novo pathway in November 2024, Valeda is the first and only FDA-authorized treatment to improve vision in patients with early and intermediate dry age-related macular degeneration.
Alcon acquired LumiThera, the developer of Valeda, in July 2025, bringing this groundbreaking technology into the world's largest eye care company. The device has been used in Europe since 2018 (CE Mark) with thousands of treatments performed globally.
"For the first time, we can offer patients with early and intermediate dry AMD a real treatment that can improve their vision. This changes the entire conversation from 'there's nothing we can do' to 'let's start treatment.'"
Photobiomodulation
Three wavelengths of light stimulate mitochondrial function in retinal cells
Non-Invasive
No injections, no drugs, no anesthesia, no dilation required
Quick Treatment
Less than 5 minutes per eye — patients resume normal activities immediately
Patient-Friendly
97%+ report no pain or discomfort during treatment
Technology & Specifications
Valeda uses multiwavelength photobiomodulation (PBM) — a non-invasive light therapy that targets the fundamental cellular dysfunction in dry AMD. The device delivers three specific wavelengths of non-coherent LED light, each targeting different cellular mechanisms in the retina.
Technical Specifications
Mechanism of Action
Targets lipofuscin and A2E in RPE cells — reduces toxic byproducts that damage retinal cells
Stimulates cytochrome c oxidase in mitochondria — increases ATP production and cellular energy
Penetrates deeper into choroid — reduces inflammation and improves blood flow
Patient Benefits
- Non-invasive — no needles, no drugs, no drops
- Quick — less than 5 minutes per eye
- Comfortable — 97%+ report no pain
- No downtime — resume normal activities immediately
Practice Benefits
- New revenue stream — recurring maintenance every 4 months
- Delegatable — QHP can administer treatments
- Minimal footprint — compact, office-based device
- Patient retention — keep dry AMD patients in-house
Clinical Evidence
The LIGHTSITE III Study
The LIGHTSITE III study was the pivotal 2-year, 10-site U.S. clinical trial that formed the basis for Valeda's FDA De Novo authorization. The study compared photobiomodulation treatment versus control light in patients with early and intermediate dry AMD (BCVA 20/32 through 20/70).
Safety Profile
- Zero treatment-related serious adverse events across all LIGHTSITE trials
- 80%+ patient adherence over 2 years — strong patient acceptance
- Most common side effect: temporary afterimage (photostress) resolving in 15-30 seconds
Indications for Use
Valeda is indicated for patients with early and intermediate dry AMD with BCVA 20/32 through 20/70, presenting with dry AMD features including ≥3 medium drusen (>63μm), large drusen (>125μm), or non-central geographic atrophy. Patients must not have neovascular (wet) maculopathy.
Competitive Landscape
The primary competition in the dry AMD space comes from complement inhibitor injections — Syfovre (pegcetacoplan) by Apellis and Izervay (avacincaptad pegol) by Astellas. However, Valeda occupies a fundamentally different position in the treatment landscape, addressing a different stage of disease with a completely different approach.
Valeda™ vs. Complement Inhibitor Injections
| Feature Area | Syfovre / Izervay (Injections) | Valeda™ (PBM) |
|---|---|---|
| Indication | Geographic atrophy (advanced dry AMD) | Early & intermediate dry AMD (BCVA 20/32–20/70) |
| Treatment Goal | Slow progression of GA (does NOT improve vision) | Improve visual acuity (~1 line ETDRS gain) |
| Delivery Method | Intravitreal injection (monthly/bimonthly) | Non-invasive light therapy (no needles, no drugs) |
| Patient Experience | Uncomfortable injection, risk of infection/inflammation | Pain-free, < 5 min per eye, 97%+ report no discomfort |
| Treatment Burden | Monthly office visits for injections indefinitely | 9 sessions over 3–5 weeks, then every 4 months |
| Safety Profile | Risk of endophthalmitis, retinal detachment, IOP elevation | Zero treatment-related serious adverse events in trials |
Pricing & Reimbursement
Valeda uses CPT code 0936T (Category III), inaugurated January 1, 2025. Each treatment course costs approximately $2,700 (9 sessions at ~$150/session/eye bilateral).
Hybrid Billing: Submit all claims to insurance, collect from those that pay, offer self-pay for denials
Patient Motivation: High willingness to pay — this is the only treatment that can improve their vision
Recurring Revenue: Maintenance every 4 months creates a predictable, compounding revenue stream
Sales Strategy
The Retina Specialist
Retina specialists who manage large volumes of dry AMD patients. They are the natural first adopters — they understand the disease, see the treatment gap daily, and have the patient base to generate immediate volume.
Lead with the Treatment Gap
Frame Valeda as the answer to 'there's nothing we can do for dry AMD'
Cite LIGHTSITE III Data
88% maintained/gained vision, ~1 line improvement, zero serious AEs
Position as First-Mover
Capture the referral network before competitors — early adopters win
Show the Revenue Model
$2,700/course with recurring maintenance every 4 months
The Comprehensive Ophthalmologist
Comprehensive ophthalmologists who currently refer dry AMD patients to retina specialists. Valeda allows them to keep these patients in-house, building a new service line and preventing patient attrition through referrals.
Keep Patients In-House
Stop losing dry AMD patients to referrals — offer treatment yourself
Easy to Implement
No retina fellowship needed, delegatable to QHP, <5 min per eye
Build a New Service Line
Recurring revenue from a patient population you already manage
Differentiate Your Practice
Be the first in your market to offer dry AMD treatment
Key Selling Messages
Transform 'Watch and Wait' into Treatment
Valeda is the first treatment that can actually improve vision in dry AMD
Non-Invasive, Patient-Friendly
No injections, no drugs, no pain — patients love it (80%+ adherence over 2 years)
A New Revenue Stream with Recurring Value
Initial course + maintenance every 4 months = predictable, compounding revenue
Handling Objections
Anticipating and effectively handling objections is critical. For Valeda, expect two primary objections: one about the science and one about reimbursement. Below are detailed response frameworks for each.
Objection 1: "Light therapy sounds like alternative medicine."
Acknowledge
"I completely understand that reaction, Doctor. It's the same skepticism many retina specialists had initially. Let me walk you through the actual science."
Lead with Mechanism
"Valeda uses three specific wavelengths — 590 nm, 660 nm, and 850 nm — that target mitochondrial cytochrome c oxidase and stimulate ATP production in retinal cells. This is well-established cellular biology."
Cite the Evidence
"The LIGHTSITE III study was a 2-year, 10-site U.S. pivotal trial. 88% maintained or gained vision, with ~1 line ETDRS improvement. Zero serious adverse events. This is what led to FDA De Novo authorization."
Close with Authority
"Alcon acquired this technology specifically because the science is compelling. They wouldn't stake their reputation on it otherwise. And the FDA created an entirely new device category for it."
Objection 2: "The reimbursement is uncertain with a Category III CPT code."
Acknowledge
"You're right to scrutinize this — your administrator should be cautious with any new technology. Let me address it directly."
Explain the Landscape
"CPT 0936T was inaugurated January 1, 2025. It's the only code for the only FDA-authorized dry AMD treatment. Many claims are already being paid by MACs in 2025."
Present the Hybrid Model
"I recommend a hybrid approach: submit all claims to insurance, collect from those that pay, and offer self-pay for denials. At ~$150/session, patients are highly motivated — this is the only treatment that can improve their vision."
Show the Math
"Even conservatively, if 30% of your dry AMD patients start treatment at $2,700/course, with maintenance every 4 months, the revenue compounds quickly. And you're capturing patients before competitors do."
Knowledge Quiz
Test your mastery of the Valeda™ value proposition. This 18-question quiz covers every section of the training guide. Score 90% or higher to confirm you are ready for customer-facing conversations.
Ready to Test Your Knowledge?
18 questions covering all sections of the Valeda™ training guide. Score 90% or higher to confirm you are field-ready.
Flashcard Review
Use these flashcards for a quick pre-meeting refresher on Valeda. Flip through key stats, product features, clinical evidence, objection responses, and competitive intelligence.
Flashcard Review
22 cards across 5 categories. Flip to reveal answers, swipe or use arrow keys to navigate. Perfect for a quick pre-meeting refresher.
Role-Play Practice
Practice your Valeda sales conversations with realistic physician scenarios. Each simulation features a different physician persona with unique concerns about dry AMD treatment.
You're Selling Hope for Dry AMD Patients
For the first time, patients with early and intermediate dry AMD have a real treatment option. Valeda transforms "there's nothing we can do" into "let's start treatment." Lead with the science, show the data, and help physicians build a new standard of care.