VYZULTA® (latanoprostene bunod ophthalmic solution, 0.024%) is a unique anti-glaucoma medication, indicated in patients with open-angle glaucoma and ocular hypertension.
The
drug is manufactured by Bausch + Lomb, USA.
It
is a combination of latanoprost acid and nitric oxide.
Latanoprost
opens up the interstitial spaces to improve uveoscleral outflow of aqueous.
Nitric
oxide improves the permeability of the trabecular meshwork and improves aqueous
outflow through the conventional pathway.
In
two Phase 3 studies, VYZULTA produced significant IOP reduction from baseline
in high-pressure-range patients (mean diurnal IOP of 26.7 mmHg) as well as
greater reduction from baseline vs timolol. Upto 9.1 mmHg of IOP reduction from
baseline was achieved. More than 30% mean diurnal IOP reduction was also noted
in these studies.
Two
Phase 3, randomized, multicenter, double-masked, parallel-group, 3-month
studies were conducted comparing the IOP-lowering effect of once-daily VYZULTA
vs twice-daily timolol 0.5% in patients with open-angle glaucoma or ocular
hypertension: APOLLO (VYZULTA, n=284; timolol, n=133) and LUNAR (VYZULTA,
n=278; timolol, n=136). VYZULTA demonstrated a mean IOP reduction of 7.5-9.1
mmHg from baseline across 9 evaluated time points over 3 months.
In
the Phase 2 dose-ranging VOYAGER study, VYZULTA delivered significantly greater
mean IOP reduction vs Xalatan (latanoprost) 0.005%.
As
compared to xalatan, 45% more patients achieved a mean diurnal IOP of less than
18 mmHg. This is a significant benchmark as IOP <18 was found to be
associated with lesser visual field progression in the Advanced Glaucoma
Intervention Study.
At
52 weeks, VYZULTA achieved 26.3% reduction from baseline IOP. Multiple studies
have apparently shown 30-40% patients having sustained IOP of <21 mmHg over
one year of use.
The
agent is used once daily in the evening.
SIDE EFFECTS:
The side effects of VYZULTA are largely similar to those seen with Latanoprost and Timolol.
However, the discontinuation rate due to the adverse effects was less than 1% in the studies reported.
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