Day One

Subretinal injections represent one of the most targeted yet invasive approaches in ocular therapy. While they are gaining ground in gene therapy development, clinical concerns remain around surgical risk, formulation demands, and long-term safety. 

This session brings a lens to the realities of delivering into the subretinal space.

• Explore the true clinical burden of subretinal delivery: a full vitrectomy, specialized surgical training, and the risk of permanent retinal detachment
• Understand why subretinal delivery has been mostly confined to gene therapy and what would need to change for devices or new modalities to enter this space
• Discuss key formulation challenges, including mechanical constraints for cells or biomaterials, and the difficulty of ensuring therapeutic distribution across the retina
• Thoughts on immunosuppressants: helpful but limited, with short-term use standard and long-term risks not yet well managed

Custom ocular injectors bring unique development and manufacturing challenges. This presentation shows how to mitigate those risks across every phase for successful clinical and commercial outcomes.

• Transforming Anti-VEGF Delivery: How Re-Vana’s sustained-release technology could reduce injection frequency for patients with retinal diseases
• Innovation at the Interface of Science & Patient Care: The science behind ReVana’s biodegradable implants and why it matters for the future of ophthalmology, including novel sustained release therapeutics 
• Opportunities for Collaboration & Impact: Where Re-Vana is today and the potential paths forward, clinical development, partnerships, and commercial strategy

The ideal opportunity to get face-to-face with many of the brightest minds in ophthalmic drug delivery and engage in important, in-depth conversations

• Minimally invasive retinal detachment to validate the delivery approach in a high-unmet-need, procedure-driven setting and de-risk broader platform development.
• How early clinical and procedural experience in retinal repair generated critical insights into precision, safety, and tissue interaction
• Evolving delivery systems to support adaptability across payload types, indications, and routes of administration without compromising procedural simplicity.

• Achieving durable efficacy in posterior segment eye diseases remains constrained by rapid intraocular clearance and frequent dosing requirements. While increasing molecular size is a proven strategy to extend vitreal half-life, common approaches such as PEGylation introduce trade-offs in biological activity, safety, and tissue penetration.
• In this presentation, we describe a protein engineering strategy developed at Mosaic Biosciences to extend intraocular pharmacokinetics using genetically encoded, large–hydrodynamic radius polypeptides composed of natural amino acids. This data highlights a modular, genetically encoded alternative to traditional size-expansion strategies and support its application to long-acting protein therapeutics for retinal diseases.

• Why does early recruitment remain a bottleneck, especially for injected therapies in conservative indications like glaucoma?
• How do we design devices and protocols for operators who aren’t traditionally trained in injection procedures? • How do we push back against unrealistic investor timelines and expectations for one-and-done cures?
• What happens when a formulation looks great in vitro but fails due to real-world hurdles like sterilization or inflammatory responses? 

This presentation will introduce age-related Macular Degeneration (AMD) affects about one-quarter of individuals over 60, leading to central vision loss and a reduced quality of life. While treatments are available and new therapies are continually being developed, accurate disease state monitoring remains crucial for both successful drug development and effective administration. The ecosystem of drug delivery devices for AMD treatments involves a network of stakeholders, including pharmaceutical companies developing anti-VEGF drugs, healthcare providers diagnosing and administering treatments, and advanced diagnostic devices monitoring disease progression. This presentation will introduce this ecosystem focusing on the administration and diagnostic aspects by highlighting examples of innovative tools for assessing AMD, incl. home use devices, that improve overall disease management and characterization of clinical end points.

As regulatory expectations evolve for ophthalmic drug-device combinations, the role of human factors in device development has become increasingly important. Usability considerations are now directly impacting design decisions, clinical strategy, and the overall regulatory path for combination products.

• Examine how early human factors work is informing device design decisions in ophthalmology, particularly for user populations with varying levels of procedural experience
• Highlight ways in which drug product characteristics for intravitreal implants can drive delivery device development
• Discuss how development teams are using early-phase, simplified delivery systems to reduce complexity and de-risk initial trials while gathering user feedback
• Explore the rationale for transitioning to more advanced delivery platforms ahead of commercialization, balancing regulatory compliance with clinician ease of use

• Introduction to extracellular vesicles (EVs): natural nanocarriers with therapeutic potential
• Advantages and challenges of EVs as ocular therapeutics and drug carriers
• Results of in vitro experiments with retinal cells
• Summary and future directions

• Preservative-Free Technology for reduced ocular surface toxicity
• Precise and reproducible Dosing for improved Treatment Adherence
• Aero Pump’s US market entrance strategies

•  The importance of matching drug formulation specifically to the delivery route rather than using a one-size-fits-all approach, ensuring compatibility with intravitreal versus other ocular delivery methods
• Challenges in maintaining drug stability and bioactivity, especially for sensitive biologics and antibodies, without modifying the drug, preserving its therapeutic effect over time
• Addressing immune response concerns in the eye where materials must be biocompatible, minimizing inflammation near delicate retinal neurons to avoid vision deterioration
• Strategies to optimize release duration and dose by tuning formulations, including sustained release over months using adaptable gels and hydrogels that can be delivered with small gauge needles

This is an informal session to help you connect with your peers in a relaxed atmosphere to continue forging new and beneficial relationships. With an audience of ophthalmology drug developers eager to hear the latest delivery advancements and device innovation, you will have the opportunity to display a poster presenting your own work and innovations. Don’t miss out on the chance to connect, learn, and present.