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

• 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

Ophthalmology faces a persistent challenge: what works in animals often fails in humans. As delivery technologies grow more complex and regulatory expectations tighten, the gap between preclinical success and clinical relevance is widening. Especially in drug-device combinations, anatomical mismatch and data inconsistency are delaying or derailing promising innovations.

• Where should we be selecting larger, more appropriate models for ocular implants and injectables, and where do small animals still offer value for early screening?
• How are companies navigating the limitations of conventional models when testing delivery systems and what do regulators actually expect for safety and efficacy data?
• Why is there a lack of transparency and shared learning across early-stage studies and how industry leaders are beginning to bridge the gap?

• 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? 

The regulatory journey for ophthalmic drug-device products is increasingly complex, especially as innovation in delivery systems accelerates. With the FDA evolving its expectations around combination products, early-stage companies, clinical teams, and strategic partners face critical questions: Should approval start with the drug or the device? How should shifting regulatory precedents be handled? And what makes getting a device approved for the eye so uniquely difficult?

• Explore how organizations are sequencing drug and device development to meet FDA expectations without slowing down trials
• Learn how the FDA’s current stance on drug-device combinations is influencing design control, clinical strategy, and filing sequence for ophthalmic products
• Understand why ophthalmic delivery systems face higher scrutiny than systemic routes, and how preclinical modelling, sterilization, and biocompatibility are being adapted to meet ocular-specific risks
• See how early-stage teams are balancing innovation and regulatory risk by starting with basic delivery systems, then phasing in novel devices or platform technologies once clinical efficacy is validated

• 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

•  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

• Both small molecules and biologics face limited bioavailability due to the eye’s natural defenses (e.g., cornea, blood-retinal barrier) and rapid clearance via tear turnover and drainage, necessitating innovative delivery strategies
• Ensuring stability during storage and delivery is critical, biologics risk aggregation and degradation, while small molecules may require solubility enhancement; biologics also raise concerns about immunogenicity
• Frequent dosing and invasive routes (e.g., intravitreal injections) challenge patient adherence. There is a growing need for less invasive, sustained-release or targeted solutions, especially for posterior eye diseases
• Advances like nanoparticles, hydrogels, in situ gels, and iontophoresis offer promising ways to enhance penetration, prolong release, and minimize dosing frequency, particularly for large molecules
• Personalized medicine, bioconjugation, and combination therapies offer new potential to address complex or rare ocular diseases, with regulatory support encouraging innovation and expanded indications

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.