Sagent Pharmaceuticals has launched travoprost ophthalmic solution, USP 0.004% to the U.S. market—the first product of its kind in the generic and specialty pharma company’s expanding portfolio.
First, a quick rundown on Sagent.
Based in Schaumburg, Illinois, Sagent was founded in 2006 with a focus on the generic injectable market across several therapeutic categories: anesthesia, anti-infectives, critical care, oncology, ophthalmic care, and urology.
And among its product types:
- Prefilled syringes (PFS)
- Premixed bags
- Vials
- Prefilled bags
Check out its complete product portfolio.
Now to this ophthalmic generic.
As we mentioned: Travoprost 0.004% is Sagent’s first ophthalmic product in its portfolio to be launched—a generic version of Novartis’s (through Sandoz, its subsidiary) TRAVATAN Z, initially FDA approved in 2001.
What to know about it: The generic formulation is a prescription-based eye drop with the active ingredient of travoprost—a prostaglandin analog (PGA; but more on that later).
- Its indication: For topical ophthalmic use to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or OHT to increase the flow of natural fluids out of the eye.
Now talk dosings.
Per the prescribing information (PI) of the name-brand version:
- One drop of the ophthalmic solution containing travoprost 0.04 mg/mL should be administered into the affected eye(s) once daily in the evening.
Circle back to this PGA component.
Prior research into PGAs has found this first-line glaucoma treatment to be the most effective medication for lowering IOP when compared to other monotherapies.
- See here for details on a recent investigation into this.
As for travoprost itself: This PGA relaxes the ciliary muscles and remodels the extracellular matrix within the eye to increase the outflow of the aqueous humor (natural fluid within the eye), creating more drainage pathways.
- In other words: It drains fluid from the eye to relieve (and reduce) IOP.
Got it. Now to safety details; any contraindications to be aware of?
Interestingly, none are listed in the eye drop’s PI.
How about warnings or precautions?
There’re definitely a few to be aware of, including:
- Pigmentation
- Most reported changes include the iris, periorbital tissue (eyelid), and eyelashes
- Eyelash changes
- Such as increased length, thickness, and eyelash number
- Intraocular inflammation (IOI)
- Caution advised for patients with active IOI (such as uveitis)
- Macular edema
- Includes cystoid macular edema; caution is also advised with aphakic patients, those with a torn posterior lens capsule, or those with known risk factors for macular edema
- Contact lenses
- Lenses should be removed prior to drop instillation and reinserted only 15 minutes after administration
See here (pages 11-12) for the complete list.
Now to potential adverse reactions.
There are two sets of adverse reactions (ARs) to be aware of: clinical trial experience (prior to regulatory approval and commercial availability) and post-marketing experience.
Looking at clinical trial data: The most common reaction was ocular hyperemia, occurring in 30% to 50% of patients.
- As for ocular ARs (attributing to 1% to 4% of patients), these included:
- Conjunctival hyperemia (attributed to up to 3% of patient discontinuations)
- Decreased visual acuity
- Eye discomfort
- Foreign body sensation
- Pain and pruritus (itching)
Other reported reactions: Abnormal and blurred vision, blepharitis, cataract, conjunctivitis, corneal staining, dry eye, and iris discoloration. Click here for more (including nonocular ARs; on page 12).
And what about those based on post-marketing experience?
Among them: Arrhythmia, vomiting, epistaxis, tachycardia, and insomnia.
Take note: These are based on voluntary reporting from patients and were included in the PI with a note cautioning that their frequency cannot be accurately estimated.
Duly noted. So … where can we find these drops for purchase?
Click here to contact the company about ordering.
Based on Sagent Pharma’s product website for the ophthalmic solution, 0.04 mg per mL multi-dose (preservative-free) bottles with varying fill volumes are available:
- 2.5 mL and 5 mL