What Do Physicians and U.S. Payers Expect from the First-to-Market Therapies Targeting Geographic Atrophy?

Geographic atrophy (GA) is the advanced dry form of age-related macular degeneration (AMD). Although vision loss caused by GA can be gradual, the disease nonetheless has a steadily increasing negative effect on the lives of affected individuals. No therapies are currently approved for the treatment of GA, and with more than 1.5 million prevalent GA cases across the G7 markets, significant opportunity exists for first-to-market agents.

Questions Answered in This Report:

  • A drug’s performance on at least seven efficacy end points, including change from baseline in best-corrected visual acuity (BCVA) at two years, is important for physician use and included in trials of emerging GA agents. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How would U.S. and European retinal specialists likely weight efficacy measures and other drug attributes in their future prescribing decisions for GA?

  • Clinically meaningful reduction in visual acuity decline and clinically relevant reduction in GA area progression are key areas of unmet need for GA, according to the insights of surveyed U.S. and European retinal specialists. Which therapies in development for GA are poised to fulfill these needs? What clinical and/or regulatory challenges must drug developers overcome in order to capitalize on these areas of unmet need? What degree of improvement do surveyed U.S. MCO PDs seek from new therapies on key clinical attributes for which surveyed physicians indicate high unmet need?

  • Roche/Genentech’s lampalizumab emerges as the future gold-standard therapy in our Drug Comparator Model because of its potentially superior clinical profile over the current treatments we evaluated. On what clinical attributes is lampalizumab most differentiated from its competitors?

Scope:

Attributes included in conjoint analysis based assessment of target product profiles for GA:

- Reduction from baseline in GA area progression (relative to placebo).

- Mean change from baseline in BCVA.

- Incidence of serious ocular side effects.

- Incidence of serious non-ocular side effects.

- Dosing frequency.

- Dosage formulation.

- Price per year.

Attributes included in assessment of U.S. payers’ receptivity to new therapies for GA and dry AMD:

- Reduced GA area progression.

- Reduced GA area progression along with the potential availability of a biomarker predictive of therapeutic response.

- Various administration profiles in GA.

- Effect on progression to advanced AMD.

Physicians surveyed: 60 U.S. and 30 European retinal specialists.

Payers surveyed: 20 U.S. MCO PDs.

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Age-Related Eye Disease Study (AREDS1) OTC supplement (Bausch & Lomb’s PreserVision, other marketers and other brands).

OTC AREDS2 supplement (Bausch & Lomb’s PreserVision AREDS 2, other marketers and other brands).

Emerging Therapies and Procedures

- Lampalizumab (Roche/Genentech).

- Emixustat (Acucela/Otsuka).

- MA09-hRPE cell transplantation (Advanced Cell Technology).

- GSK-933776 (GlaxoSmithKline).

- Sustained-release fluocinolone acetonide (Alimera Sciences/pSivida’s Iluvien/Medidur)

Author(s):

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