Aerie Pharmaceuticals Establishes GMP PRINT Production Facility in an Expanded Global Headquarters
Aerie Pharmaceuticals announced that it has built and commenced operation of its GMP (Good Manufacturing Practices)-validated manufacturing facility for production of ophthalmic implants using the proprietary PRINT (Particle Replication in Non-wetting Templates) Technology platform. As a result of the compact footprint and efficiency of the PRINT manufacturing process, the custom-designed 1,000 sq. ft. laboratory provides adequate capacity to produce all of the clinical product supply necessary for Aerie’s two lead development programs focused on retinal diseases.
Aerie has also completed its expansion at the headquarters location in Durham, North Carolina, by occupying the entire building at 4301 Emperor Boulevard. The headquarters facility now comprises a total of more than 61,000 sq. ft. and houses nearly 70 employees, making it Aerie’s largest office in the United States.
“In addition to focusing on the commercialization of our glaucoma franchise, we are actively engaged in building our pipeline, currently centered on our novel sustained release program being designed to address unmet needs in the treatment of retinal diseases,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. “Our scientists and engineers in Durham continue to advance the pipeline by pairing our proprietary molecules with sustained-release, bio-erodible polymers to deliver the full value of the innovative PRINT platform to our clinical program in retina, which we expect to initiate later in 2019.”
Aerie acquired the rights to use PRINT Technology in ophthalmology and certain other assets from Envisia Therapeutics in October 2017. Aerie is evaluating the use of PRINT Technology to manufacture fully-biodegradable polymer implants capable of sustained delivery of drug therapy to the back of the eye. The Durham PRINT GMP manufacturing laboratory will initially produce implants to support clinical trials of the AR-1105 (dexamethasone) implant and Aerie’s proprietary Rho kinase/Protein kinase C inhibitor, AR-13503 implant. These implants are designed to allow twice-yearly injections for the treatment of sight-threatening retinal conditions including diabetic macular edema and neovascular age-related macular degeneration.
Aerie is also evaluating this technology platform for sustained release of therapies to the front of the eye, including to treat glaucoma or ocular hypertension, as examples.