How Receptive Are Retinal Specialists and Payers to Emerging Therapies Offering Vision Improvements or Greater Dosing Convenience?

Anti-vascular endothelial growth factor (VEGF) therapies delivered via intravitreal injection revolutionized the treatment of wet age-related macular degeneration (AMD) such that the majority of treated patients now maintain visual acuity. In the past two years, mainstays of treatment—ranibizumab  (Roche/Genentech/Novartis’s Lucentis) and off-label bevacizumab (Roche/Genentech/Chugai’s Avastin)—have been losing patient and market share to aflibercept (Regeneron/Bayer HealthCare’s Eylea); aflibercept, which also targets VEGF, has demonstrated in clinical trials that it can be dosed less frequently than ranibizumab. Opportunity remains, however, for wet AMD therapies that improve dosing frequency. Drug developers are also seeking investigational therapies offering alternative methods of delivery and drugs that not only maintain visual acuity, but also improve it beyond the degree that can be achieved with current agents.

Questions Answered in This Report:

  • Maintaining and further improving visual acuity are key goals in the treatment of wet AMD. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European retinal specialists weight specific efficacy end points and other drug attributes in their prescribing decisions for wet AMD?

  • According to surveyed U.S. and European retinal specialists, improving visual acuity and reducing dosing frequency are key areas of unmet need in the treatment of wet AMD. Which therapies in development 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 over currently available therapies do surveyed U.S. managed care organization pharmacy directors (MCO PDs) seek from new therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?

  • Change in visual acuity and dosing frequency and formulation are key drivers of physicians’ prescribing decisions and are the focus of drug development for new wet AMD therapies. What trade-offs across these and other clinical attributes are U.S. retinal specialists willing to make when considering the use of emerging therapies for the treatment of wet AMD? Based on the trade-offs in price and performance across key drug attributes that U.S. retinal specialists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for wet AMD?

  • By 2022, E-10030 (Ophthotech’s Fovista) plus anti-VEGF therapy will emerge as the gold-standard therapy in our Drug Comparator Model because of the combination’s superior clinical profile over the key current therapies we evaluated. On what clinical attributes is adjunctive E-10030 most differentiated from its competitors? Which current therapies are at greatest risk of being replaced by adjunctive E-10030?

Scope:

Attributes included in conjoint analysis-based assessment of target product profiles for wet AMD:

- Change in visual acuity (mean number of letters gained relative to ranibizumab).

- Percentage of patients with improved visual acuity (relative to placebo).

- Risk of serious ocular side effects (relative to placebo).

- Risk of serious non-ocular side effects (relative to placebo).

- Dosing frequency.

- Dosage formulation.

- Price per year.

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

- Delivery: improved dosing frequency.

- Delivery: alternative administration.

- Efficacy: improvement of visual acuity.

- Efficacy: improvement of visual acuity as an adjunct therapy.

Physicians surveyed: 68 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

- Ranibizumab (Roche/Genentech/Novartis’s Lucentis)

- Aflibercept (Regeneron/Bayer HealthCare’s Eylea)

- Bevacizumab (Roche/Genentech/Chugai’s Avastin)

- Pegaptanib sodium (Valeant/Pfizer’s Macugen)

- Verteporfin (QLT/Novartis’s Visudyne) in combination with photodynamic therapy

Emerging Therapies

- E-10030 (Ophthotech’s Fovista)

- Sonepcizumab (Lpath’s iSONEP)

- Squalamine (Ohr Pharmaceutical)

- AGN-150998 (Allergan/Molecular Partners)

- ESBA-1008 (Alcon/Novartis)


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