Aerie PG324 Ophthalmic Solution
Research type
Research Study
Full title
A prospective, double-masked, randomized, multicenter, active- controlled, parallel-group, 6-month study assessing the safety and ocular hypotensive efficacy of PG324 Ophthalmic Solution compared to GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic Solution in subjects with elevated intraocular pressure (MERCURY 3).
IRAS ID
221541
Contact name
Rupert Bourne
Contact email
Sponsor organisation
Aerie Pharmaceuticals Ireland Ltd.
Eudract number
2015-001528-41
Duration of Study in the UK
1 years, 4 months, 11 days
Research summary
Research Summary
This is a Phase III research study of an experimental drug referred to as PG324 Ophthalmic Solution.
Glaucoma is an eye condition where the optic nerve, which connects the eye to brain, becomes damaged. It can lead to loss of vision if not detected and treated early on. It usually occurs when the fluid in the eye cannot drain properly, which increases the pressure inside the eye and puts pressure on the optic nerve. Glaucoma is a common condition, but many people won't realise they have it because it doesn't always cause symptoms in the early stages.
Aerie Pharmaceuticals Ireland is the sponsor developing PG324 Ophthalmic Solution to test the effectiveness and safety of PG324 Ophthalmic Solution , relative to GANFORT® (an approved drug which is commercially available), for lowering of the pressure of the eye(intraocular pressure, IOP) in participants with raised IOP. This study will be done at about 40 sites and will involve approximately 472 participants in 6 European countries.
Each participant will be need to undergo “washout period”, to allow certain eye medications they may be currently taking to be metabolised and removed completely from their body followed by approximately 180 days of treatment with IP.
Summary of Results
Efficacy Conclusions:
PG324 QD met the primary efficacy endpoint of clinical non-inferiority relative to Ganfort QD at all 9 time points in the primary analysis population. The robustness of this result was confirmed by secondary analyses of the primary endpoint (observed data only) in the Intent-to-Treat population.
Safety Conclusions:
PG324 QD was considered safe and well-tolerated, with relatively few reported systemic Treatment Emergent Adverse Events (TEAEs), and most TEAEs were reported as mild or moderate. No serious treatment-related TEAEs were reported in any treatment group, and no new TEAEs were reported that have not been previously observed with studies of the components netarsudil and latanoprost.REC name
London - London Bridge Research Ethics Committee
REC reference
17/LO/0525
Date of REC Opinion
27 Jun 2017
REC opinion
Further Information Favourable Opinion