Ocumetics First-in-Human Clinical Trial in Mexico: Positive 3-Month Results from Group 1
Ocumetics Technology Corporation's groundbreaking first-in-human clinical trial for their bioelectronic accommodating lens is progressing in Mexico City — with positive 3-month results from Group 1 presented at ASCRS 2026.
April 10, 2026
10
min read
By
bioaccess® Team
first-in-human trial Mexico
Ocumetics Technology
bioelectronic accommodating lens
FIH ophthalmic device
COFEPRIS clinical trial
**Key Takeaways**
- • Ocumetics Technology Corporation is conducting a first-in-human (FIH) clinical trial for their bioelectronic accommodating lens in Mexico City
- • Group 1 completed with positive 3-month follow-up results reported in February 2026
- • Group 2 surgeries are now being planned as the trial progresses
- • Results presented at ASCRS 2026 annual meeting in Washington DC on April 1, 2026
- • Mexico continues to demonstrate its strength as a premier destination for FIH ophthalmic device studies
Trial overview: Ocumetics' bioelectronic accommodating lens
Ocumetics Technology Corporation is advancing one of the most ambitious ophthalmic device programs in recent years — a bioelectronic accommodating lens designed to restore natural accommodation and potentially eliminate the need for reading glasses after cataract surgery or refractive lens exchange. The company's first-in-human (FIH) clinical trial is underway in Mexico City, marking a significant milestone for both the company and the broader landscape of first-in-human medical device trials in Latin America.
The trial is evaluating the safety and preliminary performance of the bioelectronic accommodating lens in human subjects for the first time. Unlike traditional intraocular lenses (IOLs), this device incorporates bioelectronic elements that aim to mimic the eye's natural focusing mechanism — a feat that no currently marketed device has fully achieved.
By choosing Mexico as the site for their FIH study, Ocumetics joins a growing list of innovative medtech companies that recognize Latin America's advantages for early clinical development. Mexico's regulatory framework under COFEPRIS, combined with its deep bench of experienced ophthalmology investigators, makes it an ideal location for pioneering ophthalmic device studies.
Group 1: positive 3-month results
In February 2026, Ocumetics reported positive 3-month follow-up results from Group 1 of the FIH trial. This represents a critical milestone in the early clinical development of the bioelectronic accommodating lens — the first time this technology has been implanted in human subjects and followed through a meaningful post-operative period.
While the full data from Group 1 are proprietary, the company has characterized the results as positive, indicating that the device has met its primary safety and early performance endpoints. For a first-in-human study, demonstrating a favorable safety profile at 3 months is essential before expanding enrollment to additional patient groups.
- Group 1 subjects completed 3-month post-operative follow-up
- Results characterized as positive by Ocumetics leadership
- Safety and early performance endpoints addressed
- Data supports progression to Group 2 enrollment
**Why 3-month results matter in FIH trials**
In first-in-human medical device trials, 3-month data provides the earliest meaningful signal of device safety and biological response. For intraocular devices, this timepoint captures the critical post-surgical healing period and allows investigators to assess refractive stability, visual outcomes, and any device-related adverse events. Positive 3-month data is typically required by regulatory authorities before permitting enrollment expansion.
Group 2 surgeries being planned
With the positive results from Group 1, Ocumetics is now actively planning Group 2 surgeries. This sequential enrollment approach is standard practice in early feasibility studies and FIH trials, where each patient group provides data that informs modifications or confirms the design before the next cohort is treated.
Group 2 may include modifications to the surgical technique, device design iterations, or expanded inclusion criteria based on learnings from Group 1. This iterative approach is one of the key advantages of the FIH study design — sponsors can optimize their device and surgical procedure in real-time before committing to larger pivotal studies.
Principal Investigator: Dr. Rafael Vázquez
The Ocumetics FIH trial is being conducted under the leadership of Dr. Rafael Vázquez, a distinguished ophthalmologist based in Mexico City. Dr. Vázquez serves as the Principal Investigator (PI) for the study, bringing extensive experience in anterior segment surgery and intraocular lens implantation to this groundbreaking program.
The selection of a world-class PI is critical in FIH ophthalmic device trials, where surgical technique and investigator judgment directly impact patient outcomes and data quality. Mexico City's concentration of highly trained ophthalmology specialists is one of the reasons the city has become a hub for medical device clinical trials in Mexico.
Results presented at ASCRS 2026 in Washington DC
On April 1, 2026, the milestone results from the Ocumetics FIH trial were presented at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting in Washington DC. ASCRS is the premier global conference for cataract and refractive surgery professionals, making it the ideal forum to showcase first-in-human data for a next-generation accommodating lens.
During the conference, Ocumetics CEO Dean Burns also met with strategic partners to discuss the path forward for the bioelectronic accommodating lens program. These meetings at ASCRS underscore the industry's interest in Ocumetics' technology and the growing recognition that Latin America — particularly Mexico — is a proven venue for generating high-quality FIH clinical data that is accepted by the FDA and global regulatory authorities.
| Milestone | Date | Details |
|---|---|---|
| FIH trial initiated | 2025 | Group 1 surgeries performed in Mexico City |
| Group 1 — 3-month results | February 2026 | Positive safety and early performance data |
| ASCRS presentation | April 1, 2026 | Results presented at annual meeting, Washington DC |
| Strategic partner meetings | April 1, 2026 | CEO Dean Burns met with partners at ASCRS |
| Group 2 planning | Q2 2026 | Next cohort of surgeries being planned |
Why Mexico for FIH ophthalmic device trials
The Ocumetics trial is a compelling case study in why Mexico has emerged as a premier destination for first-in-human ophthalmic device studies. Several factors make Mexico uniquely suited for this type of early clinical development:
- Regulatory efficiency: COFEPRIS clinical trial approvals typically take 8–12 weeks, compared to 6–12 months for an FDA IDE
- World-class investigators: Mexico City has a deep bench of experienced ophthalmologists trained at top international programs
- Cost advantage: FIH trial costs in Mexico are typically 40–60% lower than equivalent studies in the US or Europe
- FDA data acceptance: Clinical data generated in Mexico under ICH-GCP standards is routinely accepted by the FDA for device submissions
- Patient access: Mexico's 130M+ population provides rapid enrollment for ophthalmic conditions
- Geographic proximity: Mexico City is a 3–4 hour flight from most US cities, enabling easy sponsor oversight
| Factor | Mexico (COFEPRIS) | United States (FDA IDE) |
|---|---|---|
| Regulatory approval timeline | 8–12 weeks | 6–12 months |
| Typical FIH trial cost | 40–60% lower | Baseline |
| Investigator quality | World-class, international training | World-class |
| FDA data acceptance | Yes (ICH-GCP) | Native |
| Travel time from US | 3–4 hours | Domestic |
| Population for enrollment | 130M+ | 330M+ |
bioaccess® and FIH trials in Latin America
The Ocumetics FIH trial exemplifies how Latin America — and Mexico in particular — has become a strategic destination for medical device sponsors seeking to conduct early clinical studies. bioaccess® has been at the forefront of this movement, supporting 50+ medtech companies with first-in-human trials, early feasibility studies, and regulatory submissions across Latin America.
As a specialized CRO with deep expertise in first-in-human medical device trials, bioaccess® provides end-to-end support including:
- COFEPRIS regulatory strategy and clinical trial application submission
- Principal investigator identification and site selection across Latin America
- Ethics committee (IRB/IEC) management and informed consent development
- Full clinical operations: monitoring, data management, and safety reporting
- FDA submission support: IDE applications, pre-submissions, and data packaging
- Post-trial regulatory strategy for market access in Latin America and the US
**Ready to explore Mexico for your FIH trial?**
If you're developing an innovative medical device and considering a first-in-human clinical trial, Mexico offers a proven pathway to generate high-quality clinical data accepted by the FDA — at a fraction of the cost and time. Contact bioaccess® today to discuss your FIH strategy, or explore our FIH FastTrack process for accelerated trial setup.
Frequently asked questions
Launch your FIH trial in Mexico with bioaccess®
Join the growing list of medtech innovators using Latin America for faster, more cost-effective first-in-human studies. Our team is ready to help you navigate COFEPRIS regulations and get your device into patients.
Schedule a consultation
View case studies