*Timings are in EDT. For PDT timings download the event guide

8:00 am Virtual Breakfast Networking

8:40 am Opening Remarks from the Chair

  • David Boyer Senior Partner, Retina-Vitreous Associates Medical Group

Unmet Clinical Needs & Future Clinical Avenues in Wet AMD & DME Therapeutics

8:50 am Opening Presentation: Evaluating the Unmet Clinical Need in the Angiogenesis-Driven Diseases, Neovascular/Wet Age-Related Macular Degeneration (AMD) & Diabetic Macular Edema (DME)

  • Peter Kaiser Chaney Family Endowed Chair in Ophthalmology Research and Prof of Ophthalmology, Cleveland Clinic Lerner College of Medicine and Cole Eye Institute

Synopsis

  • Assessing the treatment burden of existing therapies and the unmet clinical need of anti-VEGF non-responders
  • Increasing the durability of anti-VEGF approaches
  • Novel pharmacological approaches being investigated to improve efficacy and durability compared to the current standard-of-care

9:15 am Future Directions to Address Unmet Clinical Need in the Treatment of Diabetic Macular Edema; How to Define NonResponder in DME? Is It Real or is There Something Else Going On?

  • Victor Chong Global Head of Medicine, Retinal Health , Boehringer Ingelheim

Synopsis

  • It is often quote that 40% of DME patients do not respond to anti-VEGF
  • Is that real?
  • How to define non-responder? Is it by retinal thickness or by BCVA?
  • Where is the real unmet need?

9:35 am Two Ways to Achieve Clinical Success: Two Vascular Systems of the Retina

  • Christine Curcio Professor – Ophthalmology & Director – Age-Related Maculopathy Histopathology Lab , University of Alabama at Birmingham

Synopsis

  • Successful treatments building on a comprehensive understanding of retinal vascular biology and pathology.
  • Layer-by-layer visualization of neovascularization types by optical coherence tomography leading to consensus nomenclature based on the laminar position of neovascularization at presentation
  • Understanding the implications for molecular targets, outcome measures, trial participant enrollment, and education of physicians, patients, and families about treatment responses and risk indicators

10:00 am Chair Led Q&A: Ensuring Clinical Success for the Emerging Therapeutic Approaches in the Management of Wet AMD & DME

  • Peter Kaiser Chaney Family Endowed Chair in Ophthalmology Research and Prof of Ophthalmology, Cleveland Clinic Lerner College of Medicine and Cole Eye Institute
  • Victor Chong Global Head of Medicine, Retinal Health , Boehringer Ingelheim
  • Christine Curcio Professor – Ophthalmology & Director – Age-Related Maculopathy Histopathology Lab , University of Alabama at Birmingham

Synopsis

  • How can we improve the current standard-of-care & ensure the clinical success of future clinical approaches?

10:15 am Functional testing in clinical studies: MAIA Microperimetry

  • William Seiple Chief Research Officer, Lighthouse Guild and Research; Professor, Department of Ophthalmology, New York University School of Medicine

Increasing Durability, Reducing Clinical Burden & Expanding Therapeutic Options for Non-Responders

10:45 am Panel Discussion: Ending the Burden of Monthly Treatments – Mechanisms to Increasing the Durability & Accessibility of Wet AMD & DME Therapeutics

  • Alan Franklin Chief Executive Officer , ForwardVue Pharma
  • Thomas Ciulla Chief Medical Officer & Chief Development Officer , Clearside BioMedical
  • Steve Pakola Chief Medical Officer , REGENXBIO
  • Michael Stewart Professor and Chairman of Ophthalmology, Mayo Clinic Department of Ophthalmology, Jacksonville, FL

Synopsis

  • Exploring extended-duration therapeutic possibilities with a focus on the anti-VEGF pathway
  • Understanding how to increase drug durability and bring more convenient, safe drug delivery options to patients
  • Achieving longer-term VEGF suppression through gene therapy, oral therapeutics or combination approaches with other drug modalities

11:20 am Virtual Networking & Break

Making Strides Forward in Drug Delivery & Dosing

11:40 am Port Delivery System with Ranibizumab: Developing the First Global Surgery, Device, Drug Combination Product for AMD & DME

  • Anne Fung Global Development Lead, PDS, Genentech

Synopsis

  • Reviewing of PDS technology and procedures
  • AMD Phase 3 clinical trial outcomes testing 6 month durability
  • Unique development aspects of a combination product

12:05 pm Non-Invasive Patient Self-Administration – Expanding Therapeutic Options for Patients With Earlier Stage Disease; Making Strides Forward in Drug Delivery & Dosing

  • Kerrie Brady Chief Executive Officer , Occuterra Therapeutics

Synopsis

  • Enabling identification of patients with earlier stage disease through expansion of sophisticated screening and diagnosis technologies employed outside the retinal surgeons offices
  • What advances are in development for patient self-administration that have potential to induce a paradigm shift from the current “watch and wait” management of these patients?
  • Currently available patient administered treatments
  • Existing targets – antiVEGF, corticosteroids
  • Emerging new targets – integrin antagonists
  • Case study: OTT166

12:30 pm Chair Led Q&A; Making Strides Forward in Drug Delivery & Dosing

  • Anne Fung Global Development Lead, PDS, Genentech
  • Kerrie Brady Chief Executive Officer , Occuterra Therapeutics

12:40 pm Virtual Networking Lunch

1:30 pm Opening Remarks from Chair

  • Carl Regillo Chief of the Retina Service, Wills Eye Hospital; Partner, Mid Atlantic Retina; and Professor of Ophthalmology, Thomas Jefferson University

1:40 pm Suprachoroidal Drug Delivery & CLS-AX: A Potential Solution for Treatment Burden

  • Thomas Ciulla Chief Medical Officer & Chief Development Officer , Clearside BioMedical

Synopsis

Suprachoroidal choroidal delivery of therapies results in:

  • Targeted high levels of therapy at the affected chorioretinal tissues, for potential efficacy benefits
  • Compartmentalization away from unaffected tissues, for potential safety benefits
  • High bioavailability
  • For small molecule suspensions, prolonged durability

Suprachoroidal CLS-AX, a proprietary suspension of Axitinib, a potent tyrosine kinase inhibitor may potentially:

  • Reduce patient burden from monthly injections to every six months
  • Yield more efficacy compared to current approaches, given the panVEGF inhibition
  • Improve long-term, real-world visual outcomes for patients
  • Provide physicians with ability to titrate dose based on patient need
  • Protect the anterior chamber from toxic exposure to TKIs

2:05 pm PRINT Drug Delivery Technology: Bringing Rho Kinase Inhibition to Retinal Vascular Diseases

Synopsis

  • Small molecule drugs address a larger set of retinal disease targets than biologics, but are limited by rapid clearance following IVT injection
  • Small molecule Rho kinase inhibitors address multiple disease mechanisms underlying AMD and DME
  • Bioerodible IVT implants produced using PRINT technology can provide controlled drug release for 6+ months
  • A Rho kinase inhibitor PRINT implant, AR-13503, has entered a Phase 1 clinical trial in AMD and DME

2:30 pm Utilizing Gene Therapy to Induce Long Term Treatment of Wet AMD & DME

Synopsis

  • Exploring the durability of gene therapy in providing long term treatment for Wet AMD & DME
  • Understanding the safety issues surrounding the constant and permanent production of anti-VEGF into the back of the eye
  • Potential treatment limitations for clinicians administering a gene therapy solution to patients

2:55 pm Chair Led Q&A: Making Strides Forward in Drug Delivery & Dosing

3:10 pm Afternoon Break

3:30 pm Opening chair remarks

  • Rishi Singh Staff Physician, Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic Foundation & Professor of Ophthalmology, Lerner College of Medicine, Case Western Reserve University ,

3:40 pm ForwardVue Pharma: Long-Acting Therapeutics For Retinal Diseases

Synopsis

• Working with Carboxyamidotriazole, CAI, which is a novel ORAI-1 blocker that diminishes intracellular calcium
• CAI is a potent anti-angiogenic inhibitor based on multiple ocular and non-ocular pre-clinical models
• CAI has an extensive human data safety set from clinical trials focused on advanced cancer
• CAI also imparts neuroprotective effects in a rodent model of ischemic retinal neovascularization
• Optimizing an intravitreal nanoparticle formulation to achieve significant durability, 6-12 months, after a single injection

4:05 pm Targeting the Tie2 Pathway for Vision Threatening Retinopathy

  • Kevin Peters Chief Scientific & Medical Officer & Senior Vice President , Aerpio Pharmaceuticals

Synopsis

  • VE-PTP inhibition is an effective pharmacologic approach to activate Tie2
  • Combining Tie2 activation via VE-PTP inhibition with anti-VEGF agents improves outcomes
  • Aerpio’s novel bispecific biologic simultaneously activates Tie2 and inhibits VEGFR2 activation

4:30 pm Chair-Led Q&A: Targeting New Therapeutic Pathways & Looking Beyond Anti-VEGF

  • Alan Franklin Chief Executive Officer , ForwardVue Pharma
  • Kevin Peters Chief Scientific & Medical Officer & Senior Vice President , Aerpio Pharmaceuticals
  • Rishi Singh Staff Physician, Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic Foundation & Professor of Ophthalmology, Lerner College of Medicine, Case Western Reserve University ,

4:40 pm Targeting TGF-β2 with Antisense Oligonucleotides as a New Therapy for wet AMD and DME

  • Marion Munk Professor, Managing Director, Bern Photographic Reading Center, University Hospital Bern; Adjunct Faculty, Dept of Ophthalmology, Northwestern University; Chief Medical Officer, Isarna Therapeutics

Synopsis

  • Isarna Therapeutics is a German, clinical stage biotech company and has an unmatched commitment to developing selective second-generation antisense oligonucleotide (ASO) blocking TGF-β production to effectively treat ophthalmic diseases.
  • The phase 1 dose escalation study confirmed the excellent safety profile
  • Currently the company is performing a phase 2 trial with the lead compound of ISTH0036 in the indications wet AMD and DME and is now raising funds.
  • Biomarker talk: Biomarkers in the treatment of wet AMD

 

5:05 pm Chair Led Q&A: Targeting New Therapeutic Pathways & Looking Beyond Anti-VEGF

  • Rishi Singh Staff Physician, Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic Foundation & Professor of Ophthalmology, Lerner College of Medicine, Case Western Reserve University ,
  • Marion Munk Professor, Managing Director, Bern Photographic Reading Center, University Hospital Bern; Adjunct Faculty, Dept of Ophthalmology, Northwestern University; Chief Medical Officer, Isarna Therapeutics

5:10 pm Chair’s Closing Remarks

5:20 pm End of Day One