India-based FDC Limited has reportedly received FDA approval for several concentrations of pilocarpine hydrochloride (HCl) ophthalmic solution.
Let’s start with FDC Limited.
Also known as FDC India—and originally founded in 1936 as Fairdeal Corporation—the pharmaceutical and healthcare company specializes in developing, manufacturing, and marketing both formulations and active pharmaceutical ingredients (APIs) distributed across the globe.
Its product portfolio includes prescription-based and over-the-counter (OTC) drugs.
- And the therapeutic areas covered: ophthalmology, anti-infective, gastroenterology, dermatology, cardiovascular, and nutraceuticals.
Now to this approval.
Take note: The FDA approved an abbreviated new drug application (ANDA) for pilocarpine—not a standard NDA.
What this is: An ANDA refers to generic drug compounds that are comparable to an already FDA-approved drug product.
- How this compares to an NDA: Unlike an NDA, preclinical and clinical data aren’t required for an ANDA to establish the safety and efficacy of a drug compound.
See here for details on the approval process, which essentially must prove that the generic drug is "bioequivalent” to its name-brand counterpart.
- And check out other recent ANDA approvals.
And in this case?
The FDA approved pilocarpine HCl in three concentrations: 1%, 2%, and 4% (each in 15 mL packages.
Let’s keep in mind:
- A name-brand version of pilocarpine HCl 0.4% launched in the U.S. earlier this year under the name QLOSI (Orasis Pharmaceuticals) following its 2023 FDA approval for the treatment of adult presbyopia.
- And prior to that, Allergan, an AbbVie company, received FDA approval in 2021 and 2023 for its once-daily and twice-daily, respectively, eye drop: Vuity (pilocarpine HCl 1.25%)—also for adult presbyopia.
Interesting … so what are the drop’s indications?
Pilocarpine HCl is indicated for:
- Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT)
- Management of acute angle-closure glaucoma (ACC)
- To note: Prior to drop use, secretory suppressant and hyperosmotic agent treatment may be needed to lower IOP below 50 mmHg and relieve iris ischemia
- Prevention of postoperative elevated IOP associated with laser surgery
- Induction of miosis (for presbyopia)
And its recommended dosings?
Administered topically, the recommended dosings depend on the indication (see here for guidance on use with other topical ophthalmic medications and for pediatric patients).
- For reduced IOP among OAG or OHT patients
- One drop (of any concentration) should be applied in the eye(s) up to four times daily (QID)
- For ACC management
- For initial management, one drop (1% or 2%) may be applied to the eye(s) up to three times (TID) over a 30-minute period
- If laser iridoplasty or iridomy is used, one drop (4%) should be applied prior to procedure
- Following laser iridoplasty, one drop (1%) should be applied QID daily until an iridotomy can be performed
- For post-op elevated IOP
- One drop (or two drops, administered 5 minutes apart) applied to the eye(s) 15 to 60 minutes prior to surgery
- For presbyopia
- One drop of any concentration (or two drops, administered 5 minutes apart) should be applied to the eye(s)
Any contraindications to be aware of?
One major: Patients with known hypersensitivity to pilocarpine.
How about warnings or precautions?
There're definitely a few more listed here, including:
- Blurred vision (patients are advised not to drive or operate machinery if experiencing this)
- Retinal detachment risk (though rare, patients should seek immediate care if experiencing a sudden onset of flashes, floaters, or vision loss)
- Iritis (drop use is advised against due to the potential for adhesions [synechiae] to form between the iris and lens)
And if patients wear contact lenses, how should they use these drops?
Wearers should remove their lenses before instilling drops in their eyes and wait 10 minutes after dosing before reinsertion.
Noted. What about other potential adverse reactions?
Based on a wide range of clinical trial data, the following reactions were most frequently reported (and largely mild, transient, and self-resolving) among participants treated with name-brand QLOSI:
- Treatment-related adverse events (AEs) among 5-8% of patients: Instillation site pain and headaches
- Ocular AEs among 2-5% of patients: Blurred vision
Other reported reactions occurring in ≥ 5% of patients following pilocarpine HCl use (for OAG or OHT) have included eye irritation, visual impairment (dim, dark, or “jumping vision”), eye pain, and accommodative change.
So … where will this be available for purchase?
Good question.
At the moment, that’s currently to be determined. Check back at FDC Limited’s product site for updates on this.