Aerie Pharmaceuticals announced that the FDA has reviewed the investigational new drug application (IND) for AR-1105 (dexamethasone intravitreal implant) and it is now in effect, allowing Aerie to initiate human studies in the treatment of macular edema due to retinal vein occlusion (RVO). The IND was submitted in December 2018. Aerie expects to initiate a phase 2 clinical study later in the first quarter of 2019.
AR-1105 is a bio-erodible implant that is designed to release the steroid dexamethasone over a 6-month sustained period. The method of administration is through commonly used intravitreal injection. The potential benefits of AR-1105 compared to other steroid products include 6-month duration of efficacy, improved administration due to a smaller needle size, and possibly a better safety profile due to lower peak drug levels.
“AR-1105 is the first IND-stage treatment in Aerie’s retina pipeline, which is an important milestone for the company,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie, said in a company news release. “This quarter we also plan to file an IND for our second retina product, a bio-erodible implant containing the Rho kinase/Protein kinase C inhibitor AR-13503 that is being developed for wet age-related macular degeneration and diabetic macular edema. These products demonstrate the potential of our two enabling platforms for delivering drugs to the back of the eye, the bio-erodible polymer technology we licensed from DSM and the PRINT manufacturing technology licensed from Envisia. As we advance these new treatments in our second significant therapeutic area in eye care, we continue to pursue our goal of building the next major ophthalmic pharmaceutical company.”