Retina is something of an “all the rage” subject in ophthalmology at the moment. If you read the recent PIE cover story (which of course you did), you’ll remember. Gene therapy, virtual and augmented reality, and outstanding pharmaceutical developments are all rocking retina.
Indeed advancements in ophthalmological pharmaceuticals are looking particularly bright going into 2021. This is despite the pall cast by coronavirus and the prospect of renewed national lockdowns. These advancements are being made possible in part by increased investment and the spurring on of scientific research.
This same applies to developments in both dry and wet age related macular degeneration (AMD). These incurable conditions are one of the leading causes of blindness — and this makes development in this area crucial.
All about Allergan
Allergan is one company that well represents this trend of development. Domiciled in Ireland, Allergan is a pharmaceutical company that acquires, develops, manufactures and markets brand name drugs and medical devices. It specializes in medical aesthetics, eye care, central nervous system and gastroenterology.
The company’s eye care wing focuses on a variety of eye conditions including glaucoma, dry eye and external eye diseases. Allergan describes itself as a global leader in eye care, and as one of the fastest-growing eye care companies worldwide. Allergan’s eye care product portfolio includes an implant to treat diabetic macular edema, eye drops for glaucoma, OPTIVE® Lubricant Eye Drops, and the REFRESH® range of artificial tears.
Allergan’s retina division has mainly focused on treating diabetic macular edema (DME). However, recent developments in the company’s structure are going to increase the breadth and depth of Allergan’s retina work.
Mr. Stewart has decades of experience in the pharmaceutical industry.
Andrew Stewart is the associate vice-president of U.S. commercial retina at Allergan, in addition to serving as executive director of corporate business development at the company. Mr. Stewart has years of experience in the pharmaceutical industry and he is particularly excited by Allergan’s developments. He points to the acquisition of the company by AbbVie, an American biopharmaceutical company, as being a particularly positive development which will spur development in the retina field.
“Abbvie is a powerhouse that gives us much more breadth and scale across different disease areas. Large neuroscience and aesthetic business are now going to become key pillars of our company,” Mr. Stewart said.
“If you are in eye care, you have to be in retina due to its profitability, large market and the high number of physicians you can reach. Retina will always be a high profile and a highly medically necessary field. Allergan’s been involved in retina for over a decade with Ozurdex,” he said.
Issues with the Feds
Ozurdex is one of Allergan’s foremost pharmaceutical products and Mr. Stewart describes it as one of the premier products in the retina field today. Ozurdex is used to treat DME, macular edema and non-infectious uveitis. While this drug remains a reliable go-to for the company, another drug is dominating its concerns at present.
Abicipar, a drug developed by Allergan to treat wet AMD, failed to secure U.S. Federal Drug Administration (FDA) approval. Citing an unfavorable benefit-risk ratio, the FDA said it was concerned by intraocular inflammation in patients using Abicipar. While recognizing that inflammation was an issue, Mr. Stewart remains convinced of the efficacy of Abicipar.
“We do have a higher rate of inflammation compared with Beovu for example, which has an inflammatory rate of 4%. However, Abicipar can offer significant help in meeting medical need, and it offers six injections a year versus 13 for ranibizumab,” Mr. Stewart said.
“The inflammation was severe, but we knew we had this challenge for the phase 3 trial. We improved our manufacturing process in a smaller study known as MAPLE trial, all of which is public knowledge,” he said.
“We have to make a determination to be better with inflammation, to meet the same safety profile as Eylea and Lucentis. I believe we will be able to do that. It will be an R&D assessment. We will know later this year and then we will make a determination to go back into clinical study with Abicipar,” Mr. Stewart concluded.