Article

SPOTLIGHT ON TECHNOLOGY & TECHNIQUE

New brimonidine-containing OTC drop relieves redness

A safe way to treat red eyes on demand.

Every day, countless individuals seek relief from red, irritated eyes, either from their eye-care provider or — more often — directly from the eyedrop aisle at the pharmacy. Many of the non-selective vasoconstrictors available over the counter (OTC) can result in users developing a tolerance after frequent administration. Patients then experience a subsequent loss of effectiveness along with rebound redness.1,2

Early in 2018, the FDA approved Lumify eyedrops from Bausch + Lomb — the first and only low-dose OTC brimonidine-containing topical drop approved to relieve ocular redness due to minor eye irritations. In clinical trials, Lumify (brimonidine tartrate ophthalmic solution 0.025%) demonstrated a strong safety and efficacy profile with virtually no rebound redness. The drops also worked quickly: Subjects had 95% symptom improvement at one minute, with the effect lasting up to eight hours.3

HOW IT WORKS

Brimonidine tartrate is an alpha-2 (α2)-adrenergic receptor agonist with a unique method of action. Because the agent selectively constricts venules, it maintains oxygen availability to surrounding tissue. (To view a video of Lumify’s mechanism of action, visit https://www.youtube.com/watch?v=mH5KudV89Ro .) Other OTC products are α1- or mixed α1-/α2- adrenergic receptor agonists that work by constricting the arterioles and venules, and they may decrease blood and oxygen flow. This mechanism results in an increased potential for rebound hyperemia and tachyphylaxis. The overuse of non-selective drops can also be toxic to the corneal surface.1,2,4,5

Brimonidine is familiar to eye-care providers at higher doses in these prescription ophthalmic products and has been clinically proven to be safe and effective since its initial 1996 approval as a prescription IOP reducer in glaucoma patients.

IN THE PRACTICE

Lumify drops have resulted in a marked whitening in the eyes of patients with various degrees of irritation, says Melissa Toyos, MD, general ophthalmologist, dry eye specialist, cataract surgeon and facial cosmetic surgeon at Toyos Clinic, Nashville, Tenn. “We have a lot of patients who are in the public eye, from actors to singers to NFL cheerleaders. But really everyone is taking selfies and wants to look their best,” she says.

Dr. Toyos’ practice is a dry eye referral center, so she sees numerous patients who have red eyes related to their conditions. Situational redness, related to factors such as winter weather or allergies, can also cause redness. “I carry a bottle of Lumify in my lab coat,” she says. “For appropriate patients, I tell them there is a new drop to relieve redness that I think they may be interested in. As I am wrapping up the visit, I instill a drop and hand them a mirror. By the time I have attended to my paperwork, patients are convinced.”

Dr. Toyos says that she advises her patients against the regular use of available OTC nonselective vasoconstrictors. “I would tell my patients they could use those products for special events only, like their wedding. It cannot be a regular thing, as they only make matters worse.1,2,4,5 Patients try to solve their own problems, and they do not realize that there is a better option until we introduce it to them.”

THE EVIDENCE

In seeking an OTC indication for Lumify, Bausch + Lomb conducted clinical trials to evaluate the safety and efficacy of low-dose brimonidine tartrate for the relief of ocular redness.1 In all, more than 600 patients were studied across six clinical trials that included both pediatric and geriatric subjects. The double-blinded, randomized, placebo-controlled Phase 3 efficacy study showed that almost all subjects reported significant symptom improvement at one minute (95% as referenced above), and 79% of them maintained significant redness reduction at eight hours. All patient groups in the studies showed a low-risk of allergic reactions.

The product, according to Lumifydrops.com , can be administered up to four times a day.3 The labeling, however, notes: “as with other OTC redness relievers, you should stop use and ask a doctor if you experience eye pain, changes in vision, redness or irritation that worsens or lasts more than 72 hours. For additional credibility, inform patients that they should still visit their eye doctor if redness persists as it could be an underlying condition.”

DETAILS

Lumify became available for purchase in major retailers nationwide, including Walgreens, CVS, Rite Aid, Walmart, Target and Amazon, in the second quarter of 2018. The bottles are available in 2.5-mL and 7.5-mL sizes, with suggested retail prices of $14.99 and $25.99, respectively. The brimonidine tartrate ophthalmic solution 0.025% product was licensed by Eye Therapies, Inc. to Bausch + Lomb Incorporated. OM

REFERENCES

  1. Vaidyanathan S, Williamson P, Clearie K, et al. Fluticasone reverses oxymetazoline-induced tachyphylaxis of response and rebound congestion. Am J Respir Crit Care Med. 2010;182:19-24.
  2. Soparkar CN, Wilhelmus KR, Koch DD, et al. Acute and chronic conjunctivitis due to over-the-counter ophthalmic decongestants. Arch Ophthalmol. 1997;115:34-38.
  3. Summary Review. Drug Approval Package: Lumify (brimonidine tartrate). FDA. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208144Orig1s000SumR.pdf . Accessed Dec. 15, 2018.
  4. Tappeiner C, Sarra GM, Abegg M. Abuse of vasoconstrictive eyedrops mimicking an ocular pemphigoid. Eur J Ophthalmol. 2009;19:129-132.
  5. Corboz MR, Rivelli MA, Mingo GG, et al. Mechanism of decongestant activity of alpha 2-adrenoceptor agonists. Pulm Pharmacol Ther. 2008;21:449-454.