. 2016 Oct 18;10:2035–2050. doi: 10.2147/OPTH.S103985

Table 2.

Latanoprostene bunod^a clinical developmental programs as of June 2016

Trial characteristics			Treatment			Outcome^b
Study Trial ID	Design	Subjects (n)	Duration	Arm(s)	Dosage group(s)	IOP reduction from baseline or IOP range, mmHg
Phase I
KRONUS NCT01895985 ⁵¹–⁵³	Single-center, controlled, open-label	24	14 d	LBN	0.024% qPM	3.6±0.8^c
Phase II
NCT00441883 ^d,⁶¹	Multicenter, randomized, controlled, double-masked, dose-finding	215	28 d	LBN	0.003%	Complete results not published
					0.006%
					0.012%
					0.024%
					0.040%
				LAT	0.005%
NCT00595101 ^d,⁶²,⁶³	Multicenter, randomized, controlled, double-masked, dose-finding	128^e	28 d	LBN^f	0.040% qAM	7.09±2.12
NCT00595101 ^d,⁶²,⁶³		128^e	28 d	LBN^f	0.040% qPM	8.20±4.01
				LAT	0.005% qPM	6.02±2.32
				LAT	0.005% qPM	7.28±2.87
VOYAGER NCT01223378 ⁵⁴–⁵⁷	Multicenter, randomized, controlled, investigator masked, dose-ranging	413	28 d	LBN	0.006% qPM	7.81
					0.012% qPM	8.26
					0.024% qPM	9.00^g
					0.040% qPM	8.93^g
				LAT	0.005% qPM	7.77
CONSTELLATION NCT01707381 ^d,⁶⁴–⁶⁷	Single-center, randomized, controlled, open-label, two-period crossover	20	8 w, crossover at 4 w	LBN	0.024% qPM	3.5±0.24^g
CONSTELLATION NCT01707381 ^d,⁶⁴–⁶⁷		20	8 w, crossover at 4 w	TIM	0.5% BID	1.7±0.25
Phase III
APOLLO NCT01749904 ⁶⁸–⁷¹	Multicenter, randomized, controlled, double-masked	420	3 m^h	LBN	0.024% qPM	17.8–18.7^g
APOLLO NCT01749904 ⁶⁸–⁷¹	Multicenter, randomized, controlled, double-masked	420	3 m^h	TIM	0.5% BID	19.1–19.8
LUNAR NCT01749930 ⁷⁰–⁷³	Multicenter, randomized, controlled, double-masked	420	3 mⁱ	LBN	0.024% qPM	17.7–19.2^g
LUNAR NCT01749930 ⁷⁰–⁷³	Multicenter, randomized, controlled, double-masked	420	3 mⁱ	TIM	0.5% BID	18.8–19.6
JUPITER NCT01895972 ^d,⁷⁴	Multicenter, open-label	130	1 y	LBN	0.024% qPM	5.3^c

Notes:

Studied as PF-03187207 (NCT00441883, NCT00595101), BOL-303259-X (VOYAGER, CONSTELLATION, APOLLO, LUNAR), and Vesneo™ (CONSTELLATION).

Primary efficacy outcome at the study’s primary endpoint; for trials with multiple primary endpoints, data from either, 1) the longest interval after treatment initiation or, 2) the largest reduction in IOP, are presented. Numerical values are presented as mean ± standard deviation, if known.

Statistically significantly different from baseline.

Complete methodology and results of trial not published to date.

Discrepant numbers of enrolled patients in this trial have been reported.

Comparisons of 0.003%, 0.006%, 0.012%, and 0.024% were additionally performed, although results have not been published.

Statistically significantly different from comparator arm.

The study’s primary endpoint, after which all subjects received LBN qPM for an additional 9 months on an open-label basis.

ⁱ

The study’s primary endpoint, after which all subjects received LBN qPM for an additional 3 months on an open-label basis. Adapted by permission from BMJ Publishing Group Limited. A randomised, controlled comparison of latanoprostene bunod and latanoprost 0.005% in the treatment of ocular hypertension and open angle glaucoma: the VOYAGER study. Weinreb RN, Ong T, Scassellati Sforzolini B, et al. Br J Ophthalmol. © 2015;99(6):738–745.⁵⁴ Data from Weinreb RN, Scassellati Sforzolini B, Vittitow J, Liebmann J. Latanoprostene bunod 0.024% versus timolol maleate 0.5% in subjects with open-angle glaucoma or ocular hypertension: the APOLLO Study. Ophthalmology. 2016;123(5):965–973.⁶⁸ Data from Medeiros FA, Martin KR, Peace J, Scassellati Sforzolini B, Vittitow JL, Weinreb RN. Comparison of Latanoprostene Bunod 0.024% and Timolol Maleate 0.5% in Open-Angle Glaucoma or Ocular Hypertension: the LUNAR Study. Am J Ophthalmol. Epub 2016 May 19.⁷²

Abbreviations: IOP, intraocular pressure; LBN, latanoprostene bunod; LAT, latanoprost; TIM, timolol maleate; qAM, every morning; qPM, every evening; BID, twice daily; d, days; w, weeks; m, months; y, year.