Patients Report Fewer Side Effects From Reproxalap Than Lifitegrast

Patients with dry eye disease (DED) tolerated the application of 2 formulations of reproxalap better than lifitegrast, according to an investigation published in Clinical Ophthalmology.

The study reviewed patient responses in 3 areas after lifitegrast ophthalmic solution 5%, reproxalap 0.25% standard formulation (SF), or reproxalap 0.25% novel formulation (NF). Investigators instilled 1 of the 3 drops into 17 patients’ eyes who were then asked to complete a questionnaire. The patients were asked questions about ocular discomfort, blurry vision, and dysgeusia (bad taste) at several points after instillation. Discomfort was rated on the ocular discomfort score (ODS) (0 to 10). The patients were seen 3 different times in 7 days. At each visit, 1 treatment was applied to both eyes by an unmasked technician. Treatments were administered 2 to 4 days apart. 

“Most prescription eye drops lead to transient instillation site discomfort,” researchers explain. But “post-acute tolerability that lasts for ≥1 hour after administration is a critical determinant of compliance, QoL, and treatment efficacy.”

Approximately two-thirds of patients with DED prescribed lifitegrast discontinue treatment after a median of 1 month, potentially due to ocular discomfort associated with the drop, researchers note. 

Reproxalap scored better than lifitegrast in ocular comfort, vision, and dysgeusia. The report shows that the probability of a negative response with regards to comfort for the Reproxalap SF groups was 10.5% and for the reproxalap NF, it was 7.4%; For lifitegrast, it was 44.9% (P =.0006, P =.0003, respectively). The dysgeusia scores were greater for the lifitegrast group vs both the reproxalap groups as well (P =.1042 and P =.0184, respectively), with 16% of the negative responders in the lifitegrast groups reporting dysgeusia. The blurry vision rating too was higher in the lifitegrast group than either reproxalap group, with 53% of the negative responders in the lifitegrast group reporting a blurry vision score of 3 (out of 10) or higher, that lasted for any duration, vs 16% in the reproxalap groups. 

Researchers report that no significant safety findings were observed following administration of any drop and all slit lamp and fundus findings were clinically insignificant, with no changes during the trial. The novel reproxalap formulation used in this study was similar to the standard formulation, except that the percent weight/volume of an excipient was modestly increased. Currently, lifitegrast is 1 of only 2 anti-inflammatory ophthalmic drugs approved by the US Food and Drug Administration for the treatment of DED, and it is the only drug approved for the treatment of the signs and symptoms of DED.

“Reproxalap has broad statistically significant advantages over lifitegrast in assessments of the most common lifitegrast side effects of ocular discomfort, blurry vision, and dysgeusia,” according to the investigators. “The superior performance of reproxalap…may result in greater patient adherence to, and lower discontinuation rates for, a novel potential prescription DED therapy.”

Disclosure: Multiple study authors declared affiliations with the biotech, pharmaceutical, and/or device companies. This study was supported by Aldeyra Therapeutics, Inc. Please see the original reference for a full list of authors’ disclosures.  

Reference

McMullin D, Clark D, Cavanagh B, Karpecki P, Brady T. Topical reproxalap 0.25% and lifitegrast 5% in patients with dry eye disease. Clin Ophthalmol. Published online September 3, 2021. doi:10.2147/OPTH.S327691