Ophthalmic First-in-Human Studies in Latin America: Why Smaller Markets Often Move Fastest

For ophthalmic medical device founders running their first-in-human (FIH) program — intravitreal injectors, glaucoma microshunts, retinal delivery platforms, intraocular lens innovations — the conventional wisdom says you go to a country with the largest patient pool and the most prestigious eye institutes. In Latin America, that usually points sponsors toward Mexico or Brazil first.

That instinct is right for pivotal studies. For an FIH or early-feasibility study with 5 to 15 patients, however, our operational experience consistently shows a different pattern: smaller markets like El Salvador, Panama, and the Dominican Republic often deliver a faster path to first patient in. Here is why, and how to think about country selection for an ophthalmic FIH program.

The FIH Math Is Different from the Pivotal Math

Pivotal studies select for patient pool depth, statistical power, and reimbursement signal. FIH studies select for something else entirely: speed to first dose, regulatory predictability, and quality of investigator engagement on a small handful of patients.

For a 10-patient ophthalmic FIH study, the binding constraint is rarely “are there enough eligible patients in the country” — almost any LATAM country has thousands of glaucoma, AMD, or refractive candidates. The binding constraints are:

• Time from sponsor decision to first ethics committee submission
• Time from EC approval to first patient screened
• Investigator focus and availability across the dosing window
• Regulatory predictability for a novel device class

On all four, smaller markets often outperform the regional giants for FIH-stage work.

Why Smaller Markets Move Faster on Ophthalmic FIH

Three structural factors explain it.

1. Lighter EC and regulatory queues. An ethics committee at a leading eye hospital in El Salvador or Panama might review three to six device protocols per quarter. The equivalent committee at a top São Paulo or Mexico City institute might be working through 30 to 60. Both are competent and rigorous; one simply has more capacity for a fast-track FIH protocol.

2. Concentrated investigator attention. In smaller markets, a leading ophthalmologist running an FIH study is not splitting attention across 12 simultaneous trials. The principal investigator has direct line of sight on every screening visit, every dosing event, every follow-up — the kind of operational intimacy that materially reduces protocol deviations and data queries on a small-N study.

3. Tighter sponsor-to-site communication. Smaller hospital systems mean fewer layers between sponsor, CRO, principal investigator, and ethics coordinator. A protocol clarification that takes a week to circulate at a large academic center can be resolved in a 30-minute call in a smaller setting.

What This Looks Like in Practice for an Ophthalmic FIH

For an intravitreal device, glaucoma microshunt, or refractive implant FIH program, a well-structured small-market approach typically looks like this:

• Single-country FIH (5–10 patients). Concentrate enrollment at one or two specialized eye centers in a smaller market. Optimize for speed and data quality, not geographic diversity.
• Validated translation and regulatory packets ready before EC submission. Smaller markets are fast on substance but unforgiving on document inconsistency.
• Compressed feasibility-to-FPI window. A 6 to 8 week target from sponsor go-decision to first patient enrolled is achievable when site, EC, and country regulator are aligned from day one.
• Clean handoff to a multi-country pivotal. Once FIH safety data is in hand, the pivotal can move to Mexico, Brazil, Argentina, or a multi-country footprint with the FIH evidence already supporting site selection conversations.

When the Conventional Path Still Wins

Smaller markets are not the right choice for every ophthalmic FIH. Three situations argue for going to Mexico or Brazil first:

• Genetic ophthalmic indications where a specific sub-population is concentrated in one large country.
• Complex imaging endpoints requiring a specific OCT, ultra-widefield imaging, or AI-assisted analysis platform that is only operational at a handful of large academic centers in the region.
• Founder-led key opinion leader strategy where the FIH publication-to-investor narrative depends on a specific principal investigator’s involvement.

For most early-stage ophthalmic device sponsors, however, the speed advantage of smaller markets at the FIH stage translates directly into reduced cash burn during the most capital-fragile window of the company’s life. In an industry where 90% of MedTech startups fail because they run out of capital before generating clinical evidence, that compression matters.

Frequently Asked Questions

How quickly can a well-designed ophthalmic FIH actually start in a smaller LATAM market?
With prepared documents, an experienced site, and a clear regulatory pathway, 6 to 10 weeks from contract signature to first patient screened is realistic. The variability comes from how prepared the sponsor’s regulatory packet is, not from the country’s regulatory speed.

Will FDA accept FIH data from El Salvador, Panama, or the Dominican Republic?
Yes, under 21 CFR 812.28, provided the study is conducted in compliance with ICH-GCP. The FDA does not maintain a country whitelist; it evaluates each study on the quality of its execution, documentation, and ethics oversight.

Should we run the FIH in a smaller market and then move the pivotal to Brazil or Mexico?
This is a common and effective sequencing strategy for ophthalmic device programs. Smaller markets optimize for speed at the FIH stage. Larger markets optimize for enrollment depth, infrastructure, and regulatory signal at the pivotal stage. Designing the FIH protocol with the eventual pivotal in mind — same imaging modalities, same primary endpoint definitions, same data capture standards — makes the transition seamless.

bioaccess® is the world’s only contract research organization built exclusively for first-in-human medical device trials, operating across 10 Latin American countries. Explore the FIH playbook at bioaccessla.com or estimate a study at bioaccessla.com/clinical-trial-calculator.