The FDA has issued multiple approvals and denials of drugs, formulations and devices over the past month.
Here are five recent ophthalmology-related FDA actions you might have missed:
Alembic s generic dorzolamide hydrochloride solution approved
Indicated for the treatment of elevated IOP in ocular hypertension or open-angle glaucoma patients, it is therapeutically equivalent to Trusopt ophthalmic solution 2% (Merck). Read more.
FDA approves Eylea prefilled syringe
The 2-mg, single-dose, sterilized prefilled Eylea (aflibercept) syringe, which requires fewer preparation steps compared with vials, is expected to be available by the end of the year. Read more.
FDA rejects Kala’s dry eye NDA, requests additional data
A complete response letter from the FDA regarding the company’s new drug application indicated that efficacy data from an additional trial will be necessary to support a resubmission. Read more.
FDA accepts application for Bimatoprost Sustained-Release
Data supporting the application from the two phase 3 ARTEMIS trials showed Bimatoprost SR reduced IOP by 30% over 12 weeks. Read more.
FDA rejects Eton’s allergic conjunctivitis drop
Eton’s partner, Bausch Health Companies, which acquired the U.S. rights to EM-100 in February, received a complete response letter from the FDA regarding the filing. Read more.