Ophthalmic Drug Development Services

• Facet team members have extensive scientific training and recent ophthalmology drug development and FDA approval experience.

• Extensive experience with dry eye, glaucoma, meibomian gland dysfunction, wet AMD, uveitis, and many rare ophthalmology diseases.

• Facet works with trusted partners and key opinion leaders in ophthalmology to help companies speed their products through development.

Facet has worked on drugs, biologics, medical device, and combination ophthalmology products:

We have prepared nonclinical, CMC, and clinical development plans for a variety of ophthalmology candidates

We have successfully sheparded Type A, B (including EOP), and C meetings with FDA’s CDER, CBER, and CDRH.  We have also been involved in multi-center meetings.

We have provided strategic oversight, content development, and finalization of IND, NDA/BLA, and 510K applications

We have successfully secured orphan designation for products that target rare ocular diseases and conditions