No significant difference was seen in efficacy and safety of prostaglandin analogues when comparing original and generics, according to a systematic review published in Ophthalmology Glaucoma.
“Three databases, PubMed, EMBASE and MEDLINE, were searched for randomized controlled trials from the marketing of the first PGA, latanoprost, in 1995 to the present date,” Alvilda T. Steensberg, MD, of the Department of Drug Design and Pharmacology at the University of Copenhagen in Copenhagen, Denmark, and colleagues wrote.
Researchers focused on 385 studies investigating the IOP-lowering effect of original prostaglandin analogues (PGAs) compared to their generic counterparts when treating individuals diagnosed with open-angle glaucoma (OAG) or ocular hypertension (OHT). The PGAs evaluated in these studies were latanoprost, travoprost, bimatoprost and tafluprost.
The primary outcome was reduction of IOP from the baseline. The secondary outcomes measured were tolerability, ocular surface health, quality of life, disease progression and cost-effectiveness.
Results included six studies involving 619 patients. Meta-analysis of all studies neglected to show clinically significant differences in efficacy between generic and original PGAs (0.23 mm Hg, CI -0.50 to 0.04 mm Hg). Both generic and original PGAs were well tolerated.
Because most studies evaluated showed at least one domain of low or unclear risk of bias, the quality of evidence is moderate, the researchers stated.
“This evidence is of moderate quality, but a small number of studies were available, and more randomized trials comparing other generic PGAs with original formulations would be useful to further investigate the robustness and generalizability of these findings,” the authors wrote. – by Erin T. Welsh
Disclosure: The authors report no relevant financial disclosures.