7:30 am | MORNING REFRESHMENTS & REGISTRATION

7:55 am Chair’s Opening Remarks

SUPRACHOROIDAL DEVICE ADVANCES FOR MAXIMAL TARGET EXPOSURE & REDUCED INFLAMMATION

8:00 am New Suprachoroidal Injector for Consistent Delivery & Novel Assessments of Spread

  • Justin Creel Executive Director, Device Development, Novartis

Synopsis

  • How can the suprachoroidal injector be improved to consistently access the suprachoroidal space across various patient anatomies?
  • Novel imaging techniques and analysis of suprachoroidal spread
  • Evaluating the pre-clinical model, performance, and coverage of suprachoroidal injections

8:30 am Delivering Targeted Long-Lasting Sustained Release Retinal Treatments Using Novel Suprachoroidal Injection

Synopsis

  • Minimally invasive suprachoroidal catheterization device for improved patient care
  • Clinical trials updates on suprachoroidal device administering sustained release dexamethasone drug product
  • Exploring drug formulation properties for successful retinal drug delivery via suprachoroidal injection

9:00 am Rapid Delivery of Therapy to the Macula using Novel Suprachoroidal Delivery Technology

Synopsis

  • Achieving rapid and extensive coverage of the posterior coverage in non-human primates and pigs leveraging a novel delivery technology
  • Compatibility and experience with gene therapy, demonstrating AAV-GFP expression at the macula in various non-human primate studies up to 85 days post injection
  • Update on first-in-human clinical trial using Everads’ suprachoroidal delivery technology

9:30 am | MORNING & NETWORKING BREAK

BALANCING FORMULATION & DEVICE FOR OPTIMAL LONG LASTING DELIVERY TO THE RETINA

10:30 am Designing & Developing Precise & Specialized Formulations for Device and Drug Products for Retinal Cell Replacement Therapy

Synopsis

  • Advantages and disadvantages of using liquid vs. hydrogel formulations for subretinal injections
  • Using gel and suspension formulations for subretinal delivery for cell replacement therapies
  • Leveraging lessons from recent studies surrounding subretinal injection of suspension formulation

11:00 am Roundtable Discussion: What is the Ideal Combination of Formulation & Device?

  • Viral Kansara Vice President, Preclinical Development, Clearside Biomedical
  • Max Cotler Chief Operating Officer, GelMEDIX

Synopsis

Discussing the Desired Characteristics for a Benchmark:

• Assessing different formulations being utilized for ophthalmic delivery and understanding their shortfalls

• Discussing the triumphs and tribulations of novel ocular delivery devices, from the hot new suprachoroidal delivery mechanism to the classic intravitreal and subretinal injections and the much-desired topical delivery method

• Examining patient concerns and burdens, surgical complications, preclinical and translation struggles of the different delivery devices and drug formulations for a better path to achieving sustained release and less frequent administration

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 up wider audience debate.

12:00 pm | LUNCH & NETWORKING BREAK

EXPLORING TOPICAL & ORAL DRUGS FOR RETINAL INDICATIONS TO IMPROVE PATIENT COMPLIANCE

1:00 pm Potential Eye Drop Treatment for Diabetic Retinopathy – Exploring the Discovery & Development of OTT166

Synopsis

  • Examining molecular design to achieve robust target selection and ocular distribution
  • Assessing preclinical and Phase I clinical trials data
  • Conduct of an eye drop study in diabetic retinopathy – learnings from an on-going double-masked Phase II clinical trial

1:30 pm Exploring Alternative Routes of Administration for Ophthalmic Diseases to Reduce Patient Concerns & Burden on Healthcare Systems

Synopsis

  • Exploring the possibility of oral drug administration for ophthalmic diseases
  • Finding the balance between efficacy and convenience of systemic drug administration for retinal diseases
  • Weighing the clinical study challenges vs. clinical practice challenges surrounding oral drug delivery

2:00 pm | AFTERNOON NETWORKING BREAK

2:30 pm One Step Closer – First Topical Candidate in Phase III Development for Diabetic Macular Edema

Synopsis

  • Enabling the formulation of drugs as topical eye drop treatment with improved solubility, higher concentration, longer residence time, and enhanced bioavailability in eye tissues, including the retina
  • Sharing phase III clinical trials data to leverage learnings for the development of non-invasive ophthalmic drug delivery
  • Achieving reduced ocular inflammation

USING NON-VIRAL DELIVERY VEHICLE TO LOCALIZE THERAPY TO TARGET RETINAL CELLS

3:00 pm Getting the Appropriate Dose of the Drug to the Target Retinal Cells for Reduced Damage to Surrounding Tissues

Synopsis

  • Utilizing non-viral delivery to localize therapeutic molecules to retinal cells
  • Achieving specificity to avoid non-targeted cells receiving the therapeutic molecules
  • Optimizing formulation for enhancing delivery to the target retinal cells

3:30 pm Chair’s Closing Remarks

3:45 pm | END OF CONFERENCE