EYBELIS OPHTHALMIC SOLUTION 0.002%

Страна: Сингапур

Език: английски

Източник: HSA (Health Sciences Authority)

Активна съставка:

Omidenepag isopropyl

Предлага се от:

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

АТС код:

S01EX06

Лекарствена форма:

SOLUTION, STERILE

Композиция:

Omidenepag isopropyl 0.02 mg/ml

Начин на приложение:

OPHTHALMIC

Вид предписание :

Prescription Only

Произведено от:

Santen Pharmaceutical Co., Ltd. Shiga Plant

Статус Оторизация:

ACTIVE

Дата Оторизация:

2021-04-07

Данни за продукта

参天製薬　754923　エイベリス点眼液（シンガポール）添付文書　MU-2617-02〈02〉ｵﾓﾃ（22/06/20）
420×120　1° コン　　大光印刷株式会社
Description
EYBELIS ophthalmic solution 0.002% is a clear, colourless and sterile
liquid. Each mL of aqueous ophthalmic
solution contains 20 micrograms of omidenepag isopropyl. The product
has pH 5.5 – 6.1 and osmolar ratio 0.9 -
1.1.
List of excipients: Benzalkonium chloride, sodium citrate hydrate,
citric acid hydrate, polyoxyl 35 castor oil,
disodium edetate hydrate, concentrated glycerin, sodium hydroxide,
dilute hydrochloric acid, purified water
ATC code
S01EX06
Pharmacodynamic properties
Mechanism of action
The mechanism of intraocular pressure (IOP) lowering effect of
omidenepag isopropyl ophthalmic solution is
considered to increase aqueous outflow via both trabecular and
uveoscleral outflow pathways by stimulating EP2
receptor.
1) Omidenepag (active metabolite) selectively bound to EP2 receptor
(Ki=3.6 nM), and showed potent agonistic
activity to EP2 receptor (EC
50
=8.3 nM).
2) Aqueous humor dynamics in monkeys with laser-induced ocular
hypertension was determined by using a
fluorophotometry method when 0.002% omidenepag isopropyl ophthalmic
solution was instilled into the monkey
eyes once daily for 7 days: No change was observed in aqueous humor
production while significant increases
were observed in outflow facility (assumed to be via the trabecular
outflow pathway) and in uveoscleral outflow.
Clinical efficacy and safety
In the Phase II/III clinical study conducted in 189 patients with
primary open angle glaucoma or ocular
hypertension in Japan, EYBELIS (once daily administration) was
compared to 0.005% latanoprost ophthalmic
solution (once daily administration). IOP lowering effect was observed
from week 1 at first scheduled visit.
Change from baseline diurneal IOP levels (Mean±SD) of this product
was -5.96±2.45 mmHg at Week 4, and the
reduction in IOP was non-inferior to the comparator.
Figure: Change in IOP reductio