Aurobindo Pharma has received approval from FDA for its abbreviated new drug application for the glaucoma medication dorzolamide hydrochloride (HCl) and timolol maleate ophthalmic solution in 2% and 0.5% concentrations.
The product is a generic equivalent to the reference listed drug Cosopt ophthalmic solution, from Akorn Operating Company.
FDA indicates the drug to reduce intraocular pressure in patients with open-angle glaucoma or ocular hypertension who don’t respond well to beta-blockers
IQVIA estimates the market size for dorzolamide HCl and timolol maleate ophthalmic solution to have a market size of $70 million for the twelve month period ending in March 2021.
FDA approvals of glaucoma eye drops Brimonidine by Somerset and Dorzolamide/Timolol by Aurobindo have created a dispensing issue where both drops have not been lasting for a 90-day timeframe on a script written for 20 ml dispensing one drop each eye twice daily. Does the FDA have any part in testing the viscosity of the drug and the size of the dispensing hole used by these companies in India? Could these shortages be because the drops are not lasting 90 days which requires doctors to request an additional bottle to fill patients need for these glaucoma meds. I am now trying MicroLabs from India for Dorzolamide and am experiencing the same problem again. A smaller hole from the dispenser could solve the problem but it means less profit to these companies. Glaucoma causes blindness and FDA should mandate smaller holes to resolve this issue. How can you assist me in resolving this problem? I’m a retired Certified Tech and have been on Dorzolamide for more than 15 yrs with No problem until now. Any suggestions? Have already filed complaint with Aurobindo and they say everyingl is correct. Pharmacists say this issue on dispensing is drug company’s responsibility but what about the FDA? Thank you!