Case Study

Sterile Compounding of Fluorescein for Lexitas’ Multi-State Phase II Clinical Trial

Summary
Maintaining diagnostic accuracy in ophthalmology clinical trials requires strict control over sterile compounding and supply execution. For a U.S. multi-state Phase II dry eye study led by Lexitas, a specialized CRO, Myonex addressed quality, consistency and timeline challenges through its wholly owned compounding pharmacy, SaveWay.

Client: Lexitas, Clinical Research Organization (CRO) specializing in ophthalmology
Study: Phase II involving patients with dry eye
Location: United States (multiple states)
Product: Sterile fluorescein vials used for diagnostic procedures

Challenge

Lexitas, a CRO dedicated to ophthalmology, needed a reliable partner to compound and supply sterile fluorescein ophthalmic solution to be used in conjunction with their sponsor’s Investigational Product (IP) for a U.S. Phase II study involving patients with dry eye.

The team sought a compounding pharmacy that could meet the sponsor’s quality standards, while guaranteeing consistent quality, regulatory compliance, and on-time delivery across numerous sites.

The main challenge was ensuring that the fluorescein ophthalmic solution was compounded with absolute consistency, as even minimal variability between batches could compromise diagnostic accuracy and impact trial results.

Timelines also posed a critical risk. Each patient required several vials over an 84-day treatment period, all compounded, tested, and distributed under strict refrigerated conditions. Any deviation or delay would have disrupted the study schedule.

Adding to the complexity, the sponsor was still comparing a couple of fluorescein ophthalmic solution formulations, which required initial testing to guide their final selection before production could begin.

The Myonex Solution

As a 503A patient-specific compounding pharmacy, SaveWay Compounding Pharmacy, a Myonex company, delivered a comprehensive sterile compounding and supply solution, while ensuring the highest levels of quality and regulatory compliance with USP Chapter <797>.

The project began with formulation support: SaveWay tested different dilutions of a commercial fluorescein presentation, enabling the sponsor to confidently select the optimal formulation for the study.

Once the formulation was confirmed, Myonex produced multiple batches of sterile fluorescein to secure sufficient shelf life while guaranteeing consistent quality from vial to vial. Each batch was released with a Certificate of Analysis and Certificate of Release following third-party laboratory testing. An initial test batch was used to validate the full quality control process to ensure patient safety, a validated method of preparation, and USP Chapter <797> compliance.

Shipments were organized according to each patient’s prescription, covering the full 84-day treatment period in two phases: one shipment for Days 1, 3*, 14, and 28, and another for Days 56 and 84 (* Day 3 applied only to the first six patients). While the first shipment was typically scheduled one week in advance, Myonex maintained the ability to ship the same day if needed, offering valuable flexibility in case of unforeseen scheduling changes. All products were shipped under 2-8°C conditions with continuous temperature monitoring and complete traceability.

To support clinical sites, Myonex also developed and provided training materials, including both handouts and an instructional video on proper vial handling, as well as prescription forms, ordering information, and sample vials for validation prior to study launch.

Results

Quality & Consistency: The compounded fluorescein met strict sterility and potency guidelines, ensuring consistency and reliable results across all diagnostic procedures.
Speed: The entire project set-up, from initial contact to first patient treated, was completed in only three months despite the need for formula development and validation, and third-party testing of the final preparation.
Compliance: All batches were compounded and released in full compliance with USP Chapter <797> and sponsor requirements, supported by external laboratory testing and comprehensive documentation.

Flexibility: Myonex leveraged compounding expertise and careful planning of workflow strategies giving them the capacity for same-day shipment when needed allowing sites to maintain study continuity even under tight timelines.
Collaboration & Satisfaction: The close partnership between Myonex, Lexitas, the CRO, and the sponsor enabled clear communication, rapid decision-making, and complete sponsor confidence

Myonex’s compounding pharmacy, SaveWay, demonstrated flexibility and accountability to help ensure our tight timelines were met with a continued focus on quality. We appreciate their partnership in this process.

– Ryan Kaiser, PMP, Vice President Operations, Lexitas

Conclusion

By combining sterile compounding expertise, rigorous quality control, and responsive logistics, Myonex ensured a flawless supply of fluorescein ophthalmic solution for a complex multi-state clinical trial driven by Lexitas. This project demonstrates how Myonex’s integrated approach, linking in-house compounding, packaging, and controlled distribution with third-party testing, provides the reliability and agility sponsors and CROs need to guarantee results reliability and maintain study continuity and patient care.

FAQ

Q1. Why were multiple compounding batches produced, and why is consistency so critical?
Producing multiple batches ensured sufficient shelf life to support the full treatment period while maintaining uninterrupted supply. Just as importantly, strict batch-to-batch consistency was essential to preserve diagnostic reliability, as any variation in the compounded fluorescein could have affected clinical assessments and study outcomes.

Q2.How quickly was the project set up from initial contact to first patient treated?
Despite the need for formulation evaluation, process validation, and third-party testing, the project was fully implemented and ready to support the first patient within three months. This accelerated timeline was achieved through close coordination between the CRO, the sponsor, and Myonex experienced teams, combined with early planning and execution discipline.