FDA Approves Valeant's Brimonidine Tartrate Ophthalmic Solution for Ocular Redness

The US Food and Drug Administration (FDA) approved the brimonidine tartrate ophthalmic solution 0.025% (LUMIFY) as an over-the-counter (OTC) therapy for ocular redness.

The solution, from Bausch and Lomb as part of Valeant Pharmaceuticals International, has become the first approved OTC eye drop for ocular redness to include low-dose brimonidine tartrate. Brimonidine was previously approved by the FDA in 1996 for the treatment of intraocular pressure reduction in patients with glaucoma.

Ocular redness is a common condition brought on by inflammation of nearly any part of the eye. While common, non-selective redness relief eye drops treat the condition by constricting blood vessels in the eye, low-dose brimonidine selectively constricts veins in the eye, and increases the availability of oxygen to surrounding tissue.

As a result, the therapy has a reduced potential for patients developing adverse effects such as treatment tolerance or rebound redness, according to the manufacturing company.

A study reviewing the efficacy and safety of the ophthalmic solution in adult patients aged 40 years or older with ocular redness found that it was well-tolerated and beneficial within hours of administration.

Researchers randomized 57 subjects in a 2:1 ratio between brimonidine (38) and vehicle (19) therapy groups. Treatment was administered 4 times daily, for 4 weeks. After each week of therapy — and the week following the treatment period’s end — patients visited researchers for assessment.

Ocular redness was assessed on a scale of 0 to 4 (with lower scores representing a decrease in redness) prior to treatment, and again 5 to 240 minutes following treatment on the first day of treatment. On days 14, 28, and 35, it was assessed 5 minutes post-treatment. Outside from researcher assessment, patients logged their assessments during the 4-week treatment period.

Assessments for safety included adverse effects, rebound redness in treatment discontinuation cases, comprehensive ophthalmic exams, and patient vital signs.

At the treatment period’s end, researchers reported a significant reduction in ocular redness score for brimonidine patients (-1.37; P < 0.0001), and again at all individual time points. Subject-assessed ocular redness was also reported as significant lower for brimonidine patients (P < 0.0005).

The few reported adverse ocular effects were mild to moderate in severity, and tachyphylaxis and redness rebound were not observed at treatment discontinuation. Researchers concluded that the solution proved safe, well-tolerated, and effective for ocular redness reduction for at least 4 hours.

Joseph C. Papa, chairman and chief executive officer of Valeant, said in a statement that LUMIFY should be available in the US market in the second quarter of 2018.

“With today's approval of LUMIFY, consumers have a new and unique treatment option to relieve red, irritated eyes," Papa said.