The eye is a highly delicate organ of the human body having various barriers that protect the eye from foreign particles. Ophthalmic drug products are preparations that deliver a drug either as drops, ointments, or injections on the eye, into the eye, or onto the conjunctiva and are used to treat various eye conditions. Strict regulatory considerations need to be followed by the industries involved in the manufacturing of ophthalmic drug products to bring a quality product with assured patient safety and therapeutic efficacy. The present chapter highlights the key regulatory aspects relevant to ophthalmic drug products, either as simple drug preparations or as drug-device combination products. In the end, a brief success story of the recent VIUTY™ eye drop is given for readers’ discretion.