The FDA has granted approval to Amneal Pharmaceuticals, Inc. for cyclosporine ophthalmic emulsion, 0.05%, a generic therapeutic indicated for the treatment of dry eye disease (DED).
This isn’t Amneal’s first generic approval, right?
Indeed, it’s not. In fact, the New Jersey-based global biopharmaceutical company—which specializes in generic and specialty products across several therapeutic areas—has already received approval for the following ophthalmic generics this year:
- In June: Prednisolone acetate ophthalmic suspension, 1% sterile
- Generic equivalent to Allergan, Inc.’s (AbbVie’s) PredForte
- In September: Bimatoprost ophthalmic solution 0.01%
- Generic equivalent to Allergan’s LUMIGAN
Now to its latest and newest addition.
Cyclosporine ophthalmic emulsion, 0.05% is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients whose tear production is suppressed due to ocular inflammation associated with keratoconjunctivitis.
- And more specifically: Cyclosporine 0.05% targets inflammation as an underlying cause of dry eye.
Also keep in mind: This isn’t the first cyclosporine 0.05% generic for dry eye to receive the FDA’s OK—those bragging rights go to Mylan Pharmaceuticals (a subsidiary of Viatris Inc.), which was granted approval in 2022.
What should we know about this generic?
As with any other generic therapeutic granted regulatory acceptance in the U.S., this eye drop’s approval is based on its formulation containing the exact same active ingredient as its brand-name drug (not to mention the same strength, quality, and effectiveness).
So there’s no difference between this generic and its brand-name equivalent?
Not in terms of their formulations.
However, the distinction between the two really comes down to pricing: this generic is intended 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.
And what’s to know about its name-brand counterpart?
That would be Restasis (cyclosporine ophthalmic emulsion) 0.05%, a registered trademark of Allergan Inc., an AbbVie company, approved in 2003.
Fun fact: Cyclosporine actually received its initial U.S. approval in 1983 for the prophylaxis of organ rejection in allogeneic kidney, liver, and heart transplants (as well as to prevent bone marrow transplant rejection.
Gotcha. So what’s the recommended dosing for cyclosporine 0.05%?
Looking at its use as an ophthalmic topical agent for dry eye:
The generic’s prescribing information (PI) advises for one drop to be instilled twice a day (BID) in each eye, approximately 12 hours apart.
- See here for the PI of the name-brand drop (which, as we mentioned, mirrors that of the generic version).
Any contraindications to be aware of?
Just one: The eye drop is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in its formulation.
How about warnings or precautions?
Its PI noted the potential for eye injury and contamination when using the eye drops; as such, caution is urged to avoid touching the vital tip to the eye or other surfaces.
And if patients wear contact lenses, how should they use these drops?
For starters: The drops shouldn’t be administered when lenses are already worn (and patients with decreased tear production are advised to not wear contact lenses).
The recommendation: Patients should remove their lenses prior to administering the drops and only reinsert the lenses 15 minutes following administration.
Noted. What about other potential adverse reactions?
These would be based on clinical trial experience used to support the drop’s approval (not its generic, but its name-brand approval, that is).
The most common adverse reaction that followed cyclosporine 0.05% use was ocular burning (occurring in 17% of patients), according to the PI.
Other reported ocular reactions (occurring in 1% to 5% of clinical trial patients) included:
- Conjunctival hyperemia
- Discharge
- Epiphora
- Eye pain
- Foreign body sensation
- Pruritus
- Stinging
- Visual disturbances (blurring being the most common)
That was clinical trial data—are there any post-marketing reports to be aware of?
Definitely a few to be aware of.
But take note: As these are based on voluntary reports from users, the PI cautions that “it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.”
These reactions include:
- Hypersensitivity (as previously noted), such as eye, tongue, and face swelling, urticaria, rare cases of severe angioedema, pharyngeal edema, and dyspnea
- Superficial injury of the eye (due to the vial tip touching the eye during administration)
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!