Age-Related Macular Degeneration (AMD): KOL Insight

May 2016 | | ID: ACE2131F96AEN
FirstWord

Abstracts

Innovation on all fronts as drug-makers and doctors reimagine wAMD treatment

Find out how next-generation VEGF inhibitors and other pipeline drugs will transform wet age-related macular degeneration (wAMD) treatment. Hear why ophthalmologists are likely to focus on combination therapies and individualised regimens. Learn about new imaging technologies that promise earlier diagnosis and better outcomes.

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Based on interviews with 12 key opinion leaders (KOLs) in North America and Europe the report brings you essential information about 3 marketed therapies and 9 pipeline drugs, and expert insight into how the wAMD treatment algorithm will evolve in the next 5 years.

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We are going to become more like cooks, saying, 'I'll take a little bit of this and a little bit of this,' and then see what works best for any given patient.” - US KOL

Expert insight into the COPD treatment landscape

KOL Insight: Wet Age-Related Macular Degeneration covers 3 marketed drugs and 9 pipeline therapies:

Marketed Drugs

VEGF Inhibitors

• Lucentis (ranibizumab; Roche/Novartis): Which three clinical trials have had the biggest influence on Lucentis prescribing? What kinds of trials to physicians want to see going forward?
• Eylea (aflibercept; Bayer/Regeneron): How important a differentiator is Eylea’s ability to cover more growth factors than Lucentis or Avastin? How does it influence treatment decisions?

Off-label Therapies

• Avastin (bevacizumab; Roche): If adopted, how will the FDA’s 2015 draft guidelines for compounded medicines affect Avastin’s prospects as an AMD treatment?

Pipeline Therapies

VEGF Inhibitors

• Brolucizumab (RTH258; Novartis): What key advantage do KOLs say brolucizumab may offer over other anti-VEGFs?
• Abicipar pegol (DARPin; Molecular Partners/Allergan): Do KOLs believe Lucentis or Eylea is a better comparator drug for abicipar pegol in Phase III trials?

Other Therapies

• Fovista (pegpleranib; OphthoTech): Which aspect of Fovista’s Phase II trials impressed KOLs. How has it influenced their expectations for Phase III trial results?
• OHR-102 (squalamine; Ohr Pharmaceutical): Why does OHR-102’s mechanism of action have some KOLs excited and others concerned about the risk of increased side effects?

Early stage programs and novel MOAs

• Ranibizumab (Port Delivery System [PDS]; Novartis/Roche): What does the Lucentis PDS have to demonstrate for KOLs to consider it a viable treatment?
• REGN21763 (aflibercept/rinucumab; Bayer/Regeneron): KOLs anticipate fierce competition between REGN21763 and Fovista? What trade-offs are involved in choosing between the two?
• RG7716 (Roche): Though they’re excited by its use of a new pathway, are KOLs optimistic about RG7716’s prospects for treating AMD?
• DE-120 (Santen): What obstacles does DE-120 face, and how do they affect its prospects versus other anti-VEGF/anti-PDGF treatments?
• X82 (Tyrogenex): What are KOLs’ chief concerns about the use of oral agents like X82 in AMD treatment?

TOP TAKEAWAYS

• Anti-VEGFs reaching their limits: Though Lucentis, Eylea, and next-generation pipeline agents will continue to play an important role, KOLs welcome new mechanisms of action.
• Eylea winning the perception war: Eylea is seen as the more effective VEGF inhibitor, but is that supported by clinical evidence? How do KOLs say it compares to Lucentis?
• Next-gen Anti VEGFs must address key concerns: There’s a clear need for more effective, longer lasting agents. Will new anti-VEGFs like brolucizumab and abicipar pegol deliver?
• Big opportunity for biosimilars: Of the three VEGF inhibitors covered in the report, one is used off-label and the other two come with hefty price tags—perfect conditions for biosimilars.
• Ant-VEGF/Anti-PDGF combinations coming soon: Fovista and REGN21763 each have distinct advantages and drawbacks. Do KOLs expect either one to be able to corner the market?
• New diagnostics could mean big changes: From early detection to more frequent testing, find out how KOLs think non-invasive, easy to administer diagnostics will improve treatment.
• Cautious approach to new delivery systems: Ophthalmologists have a clear comfort zone. What will it take for them to warm to eye drops, oral agents, and implants in the pipeline?
• Early trials underway for siRNA & other new approaches: Could synthetic small interfering ribonucleic acid (siRNA), integrin peptide, or gene therapies trigger the next wave of innovation?

Themes Explored

• Innovation on all fronts: The confluence of new drugs in the pipeline, new diagnostic tools, and new approaches is pushing wAMD treatment forward at an impressive pace. KOLs anticipate significant changes in the treatment paradigm in the next 3-5 years.
• Mixing and matching: With so many new mechanisms of action in the pipeline, KOLs expect combination therapy and add-ons to play a pivotal role in wAMD treatment.
• Treatment for one: Ophthalmologists are already shifting away from fixed dosing schedules, and KOLs expect further efforts to individualise treatment plans as researchers pursue ways to identify the patients most likely to respond to specific therapies.

A report based on expert knowledge

Key Opinion Leaders Interviewed for This Report

North American KOLs

• David S. Boyer, M.D. Senior Partner, Retina-Vitreous Associates Medical Group; Clinical Professor of Ophthalmology, University of Southern California/Keck School of Medicine, Los Angeles, CA.
• Allen C. Ho MD, FACS. Director of Retina Research, Wills Eye Hospital; Professor of Ophthalmology, Kimmel School of Medicine, Thomas Jefferson University, Philadelphia, PA.
• Peter K. Kaiser, MD. Staff member, vitreoretinal faculty, Cole Eye Institute, Department of Ophthalmology, Cleveland Clinic, Cleveland, OH.
• Carl D. Regillo, M.D., F.A.C.S. Professor of Ophthalmology, Thomas Jefferson University; Chief of Retina Service, Wills Eye Hospital and founder of the Wills Eye Clinical Retina Research Unit, Philadelphia, PA.
• Stuart Richer O.D, PhD. Chief of Optometry, DVA Medical Center; Associate professor of Family and Preventative Medicine, Chicago Medical School; Associate professor of Clinical Optometry, ICO and UMSL; Assistant professor of Ophthalmology, UIC Department of Ophthalmology / Eye and Ear Infirmary, Chicago, IL
• Srinivas R. Sadda, MD. President and Chief Scientic Officer, Doheny Eye Centre UCLA, Los Angeles, CA.

European KOLs

• Francesco Bandello, MD, FEBO. Professor and Chairman, Department of Ophthalmology, University Vita-Salute, Scientific Institute San Raffaele, Milano, Italy.
• Timothy Jackson, PhD. Consultant Ophthalmic Surgeon, King's College Hospital, London, UK.
• Professor Jean-François Korobelnik. Head of the Ophthalmology Department Groupe Hospitalier Pellegrin – CHU de Bordeaux, France.
• José Maria Ruiz-Moreno. Professor of Ophthalmology, University of Castilla La Mancha (UCLM), Spain; Clinical Chief of the Retina Albacete (CHUA) Clinical Unit.
• German KOL (Anonymous).
• German KOL (Anonymous).

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Contents

1 EXECUTIVE SUMMARY

2 RESEARCH OBJECTIVES

3 RESEARCH FOCUS

4 REPORT FOCUS

4.1 Unmet needs
  4.1.1 Longer acting treatments
  4.1.2 Improved anti-VEGF efficacy

5 VEGF INHIBITORS

5.1 Overview
5.2 Marketed drugs
  5.2.1 Lucentis (ranibizumab; Roche/Novartis)
  5.2.2 Eylea (aflibercept; Bayer/Regeneron)
5.3 Off-label VEGF inhibitors
  5.3.1 Avastin (bevacizumab; Roche)
5.4 Treatment trends
5.5 New VEGF and biosimilar opportunities
  5.5.1 New anti-VEGF opportunities
  5.5.2 Biosimilar opportunities
5.6 Pipeline Anti-VEGF therapies
  5.6.1 Brolucizumab (RTH258; Novartis)
  5.6.2 Abicipar Pegol (DARPin; Molecular Partners/Allergan)

6 OTHER LATE STAGE PIPELINE THERAPIES

6.1 Fovista (pegpleranib; OphthoTech)
6.2 OHR-102 (squalamine; Ohr Pharmaceutical)

7 EARLY STAGE PROGRAMS AND NOVEL MECHANISMS OF ACTION

7.1 Ranibizumab, Port Delivery System (PDS) (Novartis/Roche)
7.2 REGN21763 (aflibercept/rinucumab; Bayer/Regeneron)
7.3 RG7716 (Roche)
7.4 DE-120 (Santen)
7.5 X82 (Tyrogenex)

8 QUICK HITS AND NOVEL APPROACHES

8.1 Synthetic small interfering ribonucleic acid (siRNA)
8.2 Integrin peptide targeted therapies
8.3 Gene therapy

9 FUTURE TREATMENT PARADIGM

9.1 Future treatment paradigm
9.2 Future of wAMD diagnosis

10 APPENDIX

10.1 KOL biographies
  10.1.1 KOLs from North America
  10.1.2 KOLs from the EU