July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Topical VEGF receptor inhibitor, LHA510, did not demonstrate efficacy in a Proof-of-Concept study in patients with neovascular age-related macular degeneration (nv AMD)
Author Affiliations & Notes
  • Stephen H Poor
    Ophthalmology, Novartis, Cambridge, Massachusetts, United States
  • Christopher M Adams
    Ophthalmology, Novartis, Cambridge, Massachusetts, United States
  • Michael Ferriere
    Ophthalmology, Novartis, Cambridge, Massachusetts, United States
  • Andreas Weichselberger
    Ophthalmology, Novartis, Cambridge, Massachusetts, United States
  • Cynthia L Grosskreutz
    Ophthalmology, Novartis, Cambridge, Massachusetts, United States
  • Georges Weissgerber
    Ophthalmology, Novartis, Cambridge, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Stephen Poor, Novartis (E); Christopher Adams, Novartis (E); Michael Ferriere, Novartis (E); Andreas Weichselberger, Novartis (E); Cynthia Grosskreutz, Novartis (E); Georges Weissgerber, Novartis (E)
  • Footnotes
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Investigative Ophthalmology & Visual Science July 2018, Vol.59, 2394. doi:
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      Stephen H Poor, Christopher M Adams, Michael Ferriere, Andreas Weichselberger, Cynthia L Grosskreutz, Georges Weissgerber; Topical VEGF receptor inhibitor, LHA510, did not demonstrate efficacy in a Proof-of-Concept study in patients with neovascular age-related macular degeneration (nv AMD). Invest. Ophthalmol. Vis. Sci. 2018;59(9):2394.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : A randomized, double-masked, vehicle-controlled, Proof-of-Concept study for topically delivered LHA510 in patients with wet age-related macular degeneration (nv AMD).

Methods : LHA510 is a low molecular weight vascular endothelial growth factor receptor inhibitor. In contrast to oncology drugs reformulated as eye drops that failed to deliver topical efficacy in clinical trials (pazopanib and regorafenib), LHA510 was comprehensively optimized preclinically for topical application for retina indications.
This study evaluated whether topical LHA510, compared with topical vehicle, could suppress the need of intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) therapy over a 12-week period, in patients with nv AMD who require IVT anti-VEGF every 8 weeks or more frequently to prevent or treat disease recurrence. Patients were dosed b.i.d. for the first 8 weeks and t.i.d. for the last 4 weeks.

Results : The study did not meet the primary efficacy hypothesis of lower retreatment need in the LHA510 group versus the vehicle group. The key secondary efficacy endpoints were not suggestive of advantages for LHA510 relative to vehicle. Treatment emergent adverse events were primarily corneal haze and/or edema and was limited to LHA510 treated patients. Corneal haze reversed in all cases, usually within one week. There were no relevant non-ocular safety findings.

Conclusions : Effective topical ocular pharmacotherapy may be out of reach for nv AMD.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

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