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Five FDA ophthalmology actions in August
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The FDA moved forward on multiple ophthalmology-related products in the month of August. Here are the top five advancements as reported on Healio.com/OSN:
1. Retinitis pigmentosa gene therapy gets orphan drug designation.
The drug candidate, intended to specifically treat X-linked retinitis pigmentosa caused by mutations in the RPGR gene, is from Applied Genetic Technologies Corp. Read more here.
2. FDA responds to new drug application for Vyzulta.
Bausch + Lomb’s glaucoma drug candidate Vyzulta, a latanoprostene bunod ophthalmic solution, was the subject of a complete response letter from the FDA early in the month. Read more here.
3. Optovue’s epi-mapping software gets clearance .
Optovue’s epithelial thickness mapping software has become the first to be cleared by the FDA for quantitative measurements of the epithelial and stromal layers of the cornea. Read more here.
4. Ocugen’s ocular graft-versus-host disease treatment gets orphan drug designation .
An exploratory observational study showed a beneficial effect of OCU300, a brimonidine tartrate drug, in 90% of patients who were treated. Read more here.
5. Second Sight gets approval to begin Orion visual prosthesis study in human s.
The FDA granted conditional approval for a human feasibility clinical study of the Orion cortical visual prosthesis system. Read more here.