Combinations of Pilocarpine and Oxymetazoline for the Pharmacological Treatment of Presbyopia

Purpose: To determine the safety, efficacy, and tolerability of combinations of pilocarpine (Pilo) and oxymetazoline (Oxy) ocular drops dosed once daily and identify the optimal concentration of each for the pharmacologic treatment of presbyopia. Design: Two concurrent Phase 2, multicenter, double-m...

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Autores principales:	Francis W. Price, Jr., MD, Milton Hom, OD, Majid Moshirfar, MD, David Evans, OD, Haixia Liu, MD, PhD, Jeff Penzner, PharmD, Michael R. Robinson, MD, Sungwook Lee, PhD, David L. Wirta, MD
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Accommodation Oxymetazoline Pharmacological Treatment Pilocarpine Pinhole Presbyopia Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/f3ff05453a3a427e87ac7613d6ea841d
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spelling	oai:doaj.org-article:f3ff05453a3a427e87ac7613d6ea841d2021-11-14T04:36:04ZCombinations of Pilocarpine and Oxymetazoline for the Pharmacological Treatment of Presbyopia2666-914510.1016/j.xops.2021.100065https://doaj.org/article/f3ff05453a3a427e87ac7613d6ea841d2021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2666914521000634https://doaj.org/toc/2666-9145Purpose: To determine the safety, efficacy, and tolerability of combinations of pilocarpine (Pilo) and oxymetazoline (Oxy) ocular drops dosed once daily and identify the optimal concentration of each for the pharmacologic treatment of presbyopia. Design: Two concurrent Phase 2, multicenter, double-masked, randomized, vehicle-controlled studies, 1 short-term and 1 extended study. Participants: Emmetropic individuals affected by presbyopia and in good general health. Methods: Uncorrected near visual acuity (UNVA) was measured throughout both studies with various concentrations and combinations of Pilo (0%, 0.5% 1.0%, and 1.5%) and Oxy (0%, 0.0125%, 0.05%, and 0.125%). For safety, uncorrected distance visual acuity (UDVA) was measured, treatment-emergent adverse events (TEAEs) were recorded, and a temporal/supraorbital headache assessment was completed. Main Outcome Measures: The primary efficacy end point was mean change from baseline in UNVA. Results: In the short-term study, Pilo was shown to produce a significant dose response in the average increase of letters (P < 0.001), whereas Oxy did not have a significant impact (P = 0.4797). The addition or increase in concentration of Oxy did not reduce incidence or severity of headaches when compared with Pilo alone. Efficacy results from the extended study supported the results from the short-term study. As early as 15 minutes postadministration, a dose response could be seen, with peak effect at 1 hour. Peak improvement increased from day 1 to day 14 and was maintained up to day 28. The most common TEAE was headache. There was no clinically significant reduction in UDVA. A polynomial regression model was developed and determined that the optimal concentration range of Pilo is between 1.16% and 1.32%. Conclusions: On the basis of the results of the 2 Phase 2 studies, AGN-190584, a reading drop containing an optimized concentration of pilocarpine HCl (1.25%) delivered using a proprietary formulation, was developed and is currently under investigation in Phase 3 studies.Francis W. Price, Jr., MDMilton Hom, ODMajid Moshirfar, MDDavid Evans, ODHaixia Liu, MD, PhDJeff Penzner, PharmDMichael R. Robinson, MDSungwook Lee, PhDDavid L. Wirta, MDElsevierarticleAccommodationOxymetazolinePharmacological TreatmentPilocarpinePinholePresbyopiaOphthalmologyRE1-994ENOphthalmology Science, Vol 1, Iss 4, Pp 100065- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Accommodation Oxymetazoline Pharmacological Treatment Pilocarpine Pinhole Presbyopia Ophthalmology RE1-994
spellingShingle	Accommodation Oxymetazoline Pharmacological Treatment Pilocarpine Pinhole Presbyopia Ophthalmology RE1-994 Francis W. Price, Jr., MD Milton Hom, OD Majid Moshirfar, MD David Evans, OD Haixia Liu, MD, PhD Jeff Penzner, PharmD Michael R. Robinson, MD Sungwook Lee, PhD David L. Wirta, MD Combinations of Pilocarpine and Oxymetazoline for the Pharmacological Treatment of Presbyopia
description	Purpose: To determine the safety, efficacy, and tolerability of combinations of pilocarpine (Pilo) and oxymetazoline (Oxy) ocular drops dosed once daily and identify the optimal concentration of each for the pharmacologic treatment of presbyopia. Design: Two concurrent Phase 2, multicenter, double-masked, randomized, vehicle-controlled studies, 1 short-term and 1 extended study. Participants: Emmetropic individuals affected by presbyopia and in good general health. Methods: Uncorrected near visual acuity (UNVA) was measured throughout both studies with various concentrations and combinations of Pilo (0%, 0.5% 1.0%, and 1.5%) and Oxy (0%, 0.0125%, 0.05%, and 0.125%). For safety, uncorrected distance visual acuity (UDVA) was measured, treatment-emergent adverse events (TEAEs) were recorded, and a temporal/supraorbital headache assessment was completed. Main Outcome Measures: The primary efficacy end point was mean change from baseline in UNVA. Results: In the short-term study, Pilo was shown to produce a significant dose response in the average increase of letters (P < 0.001), whereas Oxy did not have a significant impact (P = 0.4797). The addition or increase in concentration of Oxy did not reduce incidence or severity of headaches when compared with Pilo alone. Efficacy results from the extended study supported the results from the short-term study. As early as 15 minutes postadministration, a dose response could be seen, with peak effect at 1 hour. Peak improvement increased from day 1 to day 14 and was maintained up to day 28. The most common TEAE was headache. There was no clinically significant reduction in UDVA. A polynomial regression model was developed and determined that the optimal concentration range of Pilo is between 1.16% and 1.32%. Conclusions: On the basis of the results of the 2 Phase 2 studies, AGN-190584, a reading drop containing an optimized concentration of pilocarpine HCl (1.25%) delivered using a proprietary formulation, was developed and is currently under investigation in Phase 3 studies.
format	article
author	Francis W. Price, Jr., MD Milton Hom, OD Majid Moshirfar, MD David Evans, OD Haixia Liu, MD, PhD Jeff Penzner, PharmD Michael R. Robinson, MD Sungwook Lee, PhD David L. Wirta, MD
author_facet	Francis W. Price, Jr., MD Milton Hom, OD Majid Moshirfar, MD David Evans, OD Haixia Liu, MD, PhD Jeff Penzner, PharmD Michael R. Robinson, MD Sungwook Lee, PhD David L. Wirta, MD
author_sort	Francis W. Price, Jr., MD
title	Combinations of Pilocarpine and Oxymetazoline for the Pharmacological Treatment of Presbyopia
title_short	Combinations of Pilocarpine and Oxymetazoline for the Pharmacological Treatment of Presbyopia
title_full	Combinations of Pilocarpine and Oxymetazoline for the Pharmacological Treatment of Presbyopia
title_fullStr	Combinations of Pilocarpine and Oxymetazoline for the Pharmacological Treatment of Presbyopia
title_full_unstemmed	Combinations of Pilocarpine and Oxymetazoline for the Pharmacological Treatment of Presbyopia
title_sort	combinations of pilocarpine and oxymetazoline for the pharmacological treatment of presbyopia
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/f3ff05453a3a427e87ac7613d6ea841d
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Combinations of Pilocarpine and Oxymetazoline for the Pharmacological Treatment of Presbyopia

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