8:00 am Check In & Morning Refreshments
8:25 am Chair’s Opening Remarks
Navigating Regulations, Safety & Retinal Topical Delivery
8:30 am Exploring the Evolving Landscape of Regulatory Approvals for Combination Products
Synopsis
- Landscape overview of current regulatory requirements
- Device design solutions to address regulatory challenges
- Future of ophthalmic drug delivery in clinical trials
9:00 am Navigating the Safety Landscape of Novel Drug Delivery
Synopsis
- Evaluating acceptable safety goals for novel therapeutic deliveries
- Addressing safety challenges associated with novel delivery technologies
- Managing adverse events related to delivery technologies
9:30 am Delving into Retinal Topical Delivery: Opportunities & How Contact Lenses Can Take Their Advantage
Synopsis
- Providing a non-invasive, cost-effective, and patient-friendly option for retinal disease treatment
- Delivering therapeutic drug levels to the back of the eye through sustained release contact lenses
- Overcoming challenges like low drug loading and fast release with innovative solutions
10:00 am Morning Break
Delivery Effective Cell & Gene Therapies to the Eye to Halt Vision Loss
10:30 am Optimizing Current Suprachoroidal & Subretinal Delivery of AAV Gene Therapies
Synopsis
- Reviewing the future landscape and the ideal delivery mechanisms to the suprachoroidal and subretinal spaces
11:00 am Enhancing Cell & Gene Therapies With Advanced Hydrogel Platforms
Synopsis
- Characterizing how hydrogel platforms impact localization and phenotype of injected cells
- Engineering formulations to improve cell viability
- Detailing the potential for tissue regeneration
11:30 am Exploring Disease Indication & Endpoint Selection for Ophthalmic Gene Therapy Trials to Unlock Optimal Results
Synopsis
- Showcasing how to replicate LUXTERNA results in subsequent RPE65 gene therapies
- Identifying the ideal volume and best vehicle
- Evaluating promotor usage, injection point and AAV virus formulation
12:00 pm Lunch
1:00 pm Panel Discussion: Delving into the Evolution of Gene Therapy for Retinal Disease
Comparing of Existing Ophthalmic Models Approaches to Supercharge Development
1:30 pm Utilizing Preclinical & Computational Models for Predicting Human Ophthalmic Drug Behavior
Synopsis
- Comparing existing rodent, pig, and rabbit models
- Troubleshooting species differences with ocular models to optimize delivery translation
- Addressing the gaps in the current models and applying computational methods for predicting PK/PD
2:00 pm Roundtable Discussion: Finding the Ideal Combination of Formulation & Device for Optimal Ocular Delivery
Synopsis
A more practical and highly interactive breakout roundtable session where attendees can crowd-source solutions and
share opinions on pre-assigned topic areas:
- Topical – How can topical treatments duration and penetration be extended?
- Injection – Strategies for optimizing with intravitreal, subretinal, and suprachoroidal injections
- Implant – Key design consideration for intraocular implants to ensure sustained drug release
Moderator Feedback & Audience Debate
Moderators will be assigned to each roundtable to facilitate discussion and collate the findings. Following the
roundtable discussions, they will present back to the entire delegation and open wider audience debate.