Amneal Pharmaceuticals, Inc. has received FDA approval for bimatoprost ophthalmic solution 0.01%, a generic therapeutic indicated for treating glaucoma and ocular hypertension (OHT) patients.
First, a look at Amneal.
The New Jersey-based global biopharmaceutical company specializes in developing a broad range (nearly 300) of generic and specialty products across various therapeutic areas.
Its portfolio extends to complex oral solids, injectables, ophthalmics, liquids, topicals, softgels, inhalation products, and transdermals.
- In fact, this past June, the company was granted FDA approval for prednisolone acetate ophthalmic suspension, 1% sterile—a generic equivalent to Allergan, Inc’s (AbbVie’s) PredForte.
Nice! Now to this latest generic.
Bimatoprost ophthalmic solution 0.01% is a prostaglandin analog (PGA) indicated for the reduction of elevated intraocular pressure (IOP) in patients diagnosed with open-angle glaucoma (OAG) or OHT.
Its generic status: Is granted based on its formulation containing the exact same active ingredient as the brand-name drug as well as the same strength, quality, and effectiveness.
The main difference: Is the pricing, with its purpose being to serve as a lower-cost alternative with the same therapeutic effect as its name-brand counterpart.
- Check out the generic approval process, which requires an abbreviated new drug application (ANDA) approval from the FDA.
Let’s talk about bimatoprost.
Bimatoprost’s U.S. regulatory history includes receiving approval in:
- 2001 for OAG and OHT (via topical administration)
- 2008 for treating eyelash hypotrichosis (via topical administration)
- 2020 for lowering IOP over several months (as an extended-release implant)
See here for a rundown on bimatoprost’s mechanism of action, including its approved indications in varying concentrations (such as 0.03%).
And its generic counterpart?
The formulation is intended to be the generic equivalent to the name brand version of bimatoprost 0.01%: LUMIGAN (Allergan, Inc., an AbbVie company).
Take note: LUMIGAN was granted FDA approval in 2010.
So what are the dosing requirements?
Per LUMIGAN’s prescribing information (PI)—which mirrors that of Amneal’ generic—one drop of the bimatoprost formulation should be administered in the affected eye(s) once daily in the evening.
- To note: The eye drop should not be administered more than this recommendation, as “it has been shown that more frequent administration of (PGAs) may decrease the (IOP) lowering effect” according to the PI.
Also: Drop use is not recommended for patients under the age of 16 due to its potential safety risk for increased pigmentation (associated with long-term chronic use).
Any contraindications to be aware of?
Just one: It’s contraindicated in patients with hypersensitivity to bimatoprost or to any of the formulation's ingredients (such as benzalkonium chloride 0.2 mg/mL, an inactive ingredient)
How about warnings or precautions?
Definitely more than the contraindications. These include:
- Pigmentation such as blepharal pigmentation and iris hyperpigmentation
- Most frequently reported changes: increased pigmentation of the iris, eyelid, and eyelashes
- Eyelash changes
- Includes vellus hair in the treated eye, with changes such as increased length, thickness, and number of lashes (typically reversible once treatment is discontinued)
- Intraocular inflammation (IOI)
- Caution is advised among patients with uveitis
- Macular edema
- This includes cystoid macular edema; caution is advised in aphakic patients and pseudophakic patients with a torn posterior lens capsule
- Bacterial keratitis
- Associated with use of multiple-dose containers of topical ophthalmic products that were "inadvertently contaminated" by patients with a concurrent corneal disease or a disruption of the ocular epithelial surface
And if patients wear contact lenses, how should they use these drops?
Keeping in mind that benzalkonium chloride is included in its formulation, the PI notes that this ingredient “may be absorbed by and cause discoloration of soft contact lenses.”
- As such: Lenses should be removed prior to topically applying the drops and only reinserted 15 minutes after administration.
Noted. What about other potential adverse reactions?
These would be based on clinical trial experience used to support the drop’s approval.
In this case, the name brand drug was evaluated in a 12-month study that found the most common adverse reactions to include conjunctival hyperemia—occuring in 31% of patients and resulting in 1.6% of discontinuations.
- Other reactions (reported in 1% to 4% of participants) included conjunctival edema and hemorrhage; eye irritation, pain, and pruritus; erythema of the eyelid; eyelids pruritus; punctate keratitis; blurry vision; and reduced visual acuity.
- See the full list (Section 6.1)
That was clinical trial data—are there any post-marketing reports to be aware of?
There are. These voluntarily reported reactions (coming from a “population of uncertain size”) vary from asthma-like symptoms to dizziness, dry eye, headaches, hypertension, and photophobia.
Click here (Section 6.2) for a more detailed rundown on this.
Also duly noted. So … where will this be available for purchase?
No word yet on that front … check back with Amneal for details in the near future!