Efficacy and Safety of a 2% Dorzolamide/ 0.5% Timolol Fixed-Combination Brand: Mardozia®
Keywords:
primary open angle glaucoma, normal tension glaucoma, ocular hypertension, dorzolamide, timololAbstract
Objective: To evaluate efficacy and safety of Mardozia® (2% Dorzolamide/0.5% Timolol fixed combination) drugs in glaucoma patients, specifically in Thai population.
Methods: The multicenter, prospective, randomized, open label study in POAG, NTG and OHT which used brand name (Cosopt®) with or without PGs at least 3 months then drug washout for one month and switch to generic drug (Mardozia®), total study seven months period. The IOP was measured baseline on branded medication, month 0 and post-switch at month 1, 3 and 6. The questionnaire on the discomfort symptoms and discomfort score for the use of eye drops answered by the patients before baseline on branded medication and month 6 after received.
Results: A total of 60 eyes who receive brand name with or without PGs at least 3 months were enrolled in the study (71.7% female, median age 68.5 years old). At the end of the follow-up month 6 (visit 5) of Mardozia®, mean IOP was 13.82 ± 3.22 mmHg, reduced from baseline 2.7 ± 3.03 mm Hg (14.88%, p < 0.001) and IOP reduction was not significant difference compared with brand name at baseline on branded medication (0.91mmHg) (-5.35%). There was, likewise, significant difference in the discomfort score (P < 0.001).
Conclusion: Mardozia® is effective in reducing IOP for glaucoma patients. The effect was seen significantly since first month and continued until the last follow-up. After the switch, the IOP-lowering effect of the generic drug Mardozia® was comparable to the brand name. Overall safety is better after switching. Patients had less adverse drug reactions and were more comfortable with Mardozia® significantly.
References
Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol 2006;90:262-7. doi: 10.1136/ bjo.2005.081224. Pubmed PMID: 16488940.
Chantra S. Eye problem in aging. Healthtoday Thailand. 2553:10(110): 88-91.
IQVIA MAT Q2/2022, Tims (Thailand) Co.,Ltd.
Kass MA, Heuer DK, Higginbotham EJ, et al. The ocular hypertension treatment study: A randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open‑angle glaucoma. Arch Ophthalmol 2002;120:701‑13.
Lichter PR, Musch DC, Gillespie BW, et al. Interim clinical outcomes in the collaborative initial glaucoma treatment study comparing initial treatment randomized to medications or surgery. Ophthalmology 2001;108:1943‑53.
Sezgin Akçay BI, Güney E, Bozkurt KT, Unlü C, Akçali G. The safety and efficacy of brinzolamide 1% timolol 0.5% fixed combination versus dorzolamide 2%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension. J Ocul Pharmacol Ther. 2013;29:882-6. doi: 10.1089/jop.2013.0102.
Heijl A, Leske MC, Bengtsson B, Hyman L, Bengtsson B, Hussein M Early Manifest Glaucoma Trial Group. Reduction of intraocular pressure and glaucoma progression: Results from the early manifest glaucoma trial. Arch Ophthalmol. 2002;120:1268-79. doi: 10.1001/archopht.120.10.1268.
Tae-Woo Kim, Martha Kim, Eun Ji Lee, et al. Intraocular pressure-lowering efficacy of dorzolamide/ timolol fixed combination in normal-tension glaucoma. Journal of Glaucoma. 2014;23(5):329-32.
Erik L. Greve MD, PHD, Alexander H. Rulo MD,Stephen M. Drance OC, MD. Reduced intraocular pressure and increased ocular perfusion pressure in normal tension glaucoma: A review of short-term studies with three dose regimens of latanoprost treatment. Survey of Ophthalmology Volume 41, Supplement 2, February 1997, Pages S89-S92.
Inder Paul Singh, MD. Setting Target Pressures. Glaucoma Today. September/October 2015.
Yong Il Kim, Jee Hyun Kim, Tae Yoon Lee, et al. Efficacy and Safety of Glaucoma Patients’ Switch from a 2% Dorzolamide/0.5% Timolol Fixed-Combination Brand-Name Drug to Its Generic Counterpart. Journal of Ocular Pharmacology and therapeutics. 2015;31, Number 6.
Narayanaswamy A, Neog A, Baskaran M, et al.A randomized, crossover, open label pilot study to evaluate the efficacy and safety of Xalatan in comparison with generic Latanoprost (Latoprost) in subjects with primary open angle glaucoma or ocular hypertension. Indian J. Ophthalmol. 2007;55:127-31.
Peter Meredith. Bioequivalence and other unresolved issues in generic drug substitution. Clin. Ther. 2003;25: 2875-90.
Fiscella R.G., Gaynes B.I., and Jensen M., et al. Equivalence of generic and brand-name ophthalmic products. American Journal of Health-System Pharmacy. 2001;58:616-7.
Mammo Z.N., Flanagan J.G., James D.F., et al. Generic versus brand-name North American topical glaucoma drops. Can J Ophthalmol. 2012;47:55-61.
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The Thai Journal of Ophthalmology (TJO) is a peer-reviewed, scientific journal published biannually for the Royal College of Ophthalmologists of Thailand. The objectives of the journal is to provide up to date scientific knowledge in the field of ophthalmology, provide ophthalmologists with continuing education, promote cooperation, and sharing of opinion among readers.
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