Key Commercialization Questions for Wet & Dry AMD Drugs in Development

RxC International’s experience in the Age-related Macular Degeneration (AMD) market has driven us to ask key questions about future products in the wet and dry AMD market.  We collaborate with our clients to identify the best path to commercialization.  Our team has assembled the most important questions below.

GA - Dry AMD

Geographic Atrophy (GA – Dry AMD) is an advanced form of AMD and is a progressive, irreversible and blinding disease affecting approximately ~4.4M people worldwide.  GA represents a significant unmet medical need as there are no approved treatments for either onset or progression of this condition. Emerging research is helping identify patients with higher risk for both development and rapid progression of GA.  The therapeutic frontrunners for GA, Zimura and Roche’s lampalizumab, are both complement inhibitors.

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Key Questions for Dry AMD Product Development

  • How best to address the significant unmet medical need in GA?

  • What are the best targets to develop medical therapies for GA?

  • How to develop a biomarker to diagnose GA and to track disease progression?

  • What primary and secondary endpoints should be considered for clinical studies?

  • How to structure clinical studies to gain regulatory approval?

  • How to show clinical and economic value of GA therapies and gain competitive advantage?

Wet AMD

Wet AMD is preceded by dry AMD where, in some cases, abnormal blood vessels invade the cornea and is the leading cause of blindness for people over 55 years of age.  Currently two approved treatments are available, Lucentis and Eylea, with a combined worldwide revenue of $8.8B in 2016. HCPs have been prescribing Avastin off-label in the US and around the world and is preferred due to the low cost.  Though combination (anti-VEGF and anti-PDGF) therapies have failed, there are other therapies under development to offer more efficacious and less frequent dosing options.

Key Questions for Wet AMD Product Development

  • How effective are these next generation Wet AMD therapies that offer more effective and convenient treatment choices?

  • How to develop treatment strategies to adjust frequency of dosing (PRN)?

  • How to develop biomarkers to track disease progression?

  • How to address remaining unmet needs (not all patients respond well and some are turning into refractory patients for current treatments)?

  • How to develop and offer personalized therapies in wet AMD to increase treatment effectiveness and patient engagement for best outcomes?

  • What life cycle management opportunities exist?  How best to capitalize on these opportunities?

About RxC International

RxC International has done significant work in GA and wet AMD to address the questions above.  These projects range from strategic market assessments to life cycle opportunities to valuation of assets in AMD therapeutic areas.  To learn how we can assist your company with developing and commercializing wet and dry AMD therapies, please contact us.