ClarVista Medical — From First-in-Human to Alcon Acquisition — A LATAM Success Story

ClarVista Medical developed a revolutionary modular intraocular lens (IOL) that could be customized post-implantation. bioaccess® managed the first-in-human clinical trials in Latin America that generated the data leading to ClarVista's acquisition by Alcon.

Study facts

• Sponsor / company: ClarVista Medical
• Indication / area: Ophthalmology
• Country: Colombia
• Study type: First-in-Human (FIH)

Key metrics

• Trial Type: FIH
• Exit: Acquired by Alcon
• Regulatory: FDA + CE ready
• Timeline: Accelerated

The challenge

ClarVista's modular IOL represented a paradigm shift in cataract surgery—allowing surgeons to adjust lens power after implantation. The company needed rapid first-in-human safety and performance data to validate the concept and attract strategic acquirers, but US regulatory timelines would have delayed this by over a year.

bioaccess® solution

bioaccess® executed the first-in-human study in Colombia with experienced ophthalmic surgeons, managing regulatory approval, surgical training, patient enrollment, and structured visual acuity follow-up assessments. The data package was designed to meet both FDA IDE and CE Mark requirements.

Results

• First-in-human implantations completed successfully in Colombia
• Safety and visual acuity outcomes validated the modular IOL concept
• Clinical data attracted strategic interest from major ophthalmic companies
• ClarVista acquired by Alcon—a landmark exit for the startup
• Total time from FIH to acquisition significantly accelerated by LATAM pathway

Frequently asked

What did bioaccess® do for ClarVista Medical?

bioaccess® executed the first-in-human study in Colombia with experienced ophthalmic surgeons, managing regulatory approval, surgical training, patient enrollment, and structured visual acuity follow-up assessments. The data package was designed to meet both FDA IDE and CE Mark requirements.

Where was the ClarVista Medical First-in-Human (FIH) study run?

The ClarVista Medical First-in-Human (FIH) study was executed in Colombia by bioaccess® in the ophthalmology area.

What was the outcome of the ClarVista Medical study?

Reported outcomes for ClarVista Medical's device: First-in-human implantations completed successfully in Colombia; Safety and visual acuity outcomes validated the modular IOL concept; Clinical data attracted strategic interest from major ophthalmic companies.

Run a similar trial: Clinical trials in Colombia

First-in-Human Clinical Trials pillar · LATAM FIH Benchmarks 2026 · ← All case studies · Contact bioaccess®