New Dorzolamide Hydrochloride Ophthalmic Solution Receives FDA Approval

Alembic Pharmaceuticals has received FDA approval for Dorzolamide Hydrochloride Ophthalmic Solution USP, 2%, a product that is therapeutically equivalent to Trusopt Ophthalmic Solution, 2% (Merck).¹

Dorzolamide is used to treat high intraocular pressure due to open-angle glaucoma or other eye diseases such as ocular hypertension. Lowering that high pressure can be vital to preventing blindness.

Ocular hypertension can cause glaucoma and permanent vision loss if left untreated. In open-angle glaucoma, the angle in the eye where the iris meets the cornea is as open as it should be, but the eye’s drainage canals become clogged over time, causing an increase in internal eye pressure and subsequent damage to the optic nerve.²

As a carbonic anhydrase inhibitor, ophthalmic solution containing dorzolamide hydrochloride works by suppressing the activity of carbonic anhydrase, an enzyme which assists rapid interconversion of carbon dioxide and water into carbonic acid, protons, and bicarbonate ions.³

The 2% ophthalmic solution has an estimated market size of $35 million for the 12 months preceding December 2018, according to IQVIA.¹

References

• Alembic Pharmaceuticals receives USFDA Approval for Dorzolamide Hydrochloride Ophthalmic Solution USP, 2% [News Release]. Vadodara, India; August, 13, 2019: Alembic Pharmaceuticals. https://www.alembicpharmaceuticals.com/wp-content/uploads/2019/08/Press-Release-USFDA-Approval-Dorzolamide-Hydrochloride-Ophthalmic-Solution-USP-August-2019. Accessed August 2019.
• Symptoms of Open-Angle Glaucoma. Glaucoma Research Foundation. https://www.glaucoma.org/glaucoma/symptoms-of-primary-open-angle-glaucoma.php. Accessed August 2019.
• PDB101: Molecule of the Month: Carbonic Anhydrase. RCSB. https://pdb101.rcsb.org/motm/49. Accessed August 2019.