A cloudy ophthalmic space got a little clearer Wednesday with the two collaborations by Visus Therapeutics and Outlook Therapeutics, now preparing for FDA approval.
A cloudy ophthalmic space got a little clearer Wednesday with the announcements of two collaborations by Visus Therapeutics and Outlook Therapeutics, now preparing for FDA approval.
Outlook Therapeutics also tapped AmerisourceBergen to distribute ONS-5010. ONS-5010 is the monoclonal antibody bevacizumab to treat wet age-related macular degeneration, commonly referred to as wet AMD and other eye diseases.
Bevacizumab is one of the oldest monoclonal antibodies on the market, developed by Roche’s Genentech and previously approved to treat several cancers. Its best known under the brand name Avastin.
Outlook submitted a biologics license application to treat eye disease in March, but the FDA required the company to submit more data over the summer.
Analysts expect approval of the eye drug candidate, brand named Lytenava, sometime in 2023.
Outlook previously partnered with FUJIFILM Diosynth Biotechnologies and Ajinomoto Bio-pharma Services for material sourcing and manufacturing assistance in anticipation of a commercial launch.
“Following our recent Biologics License Application submission, entering a relationship with AmerisourceBergen for ONS-5010 is a critical step in the next phase of our pre-commercial strategy execution,” said Outlook Pres. and CEO C. Russell Trenary, III in a statement.
If ONS-5010 is approved, AmerisourceBergen’s Besse Medical will handle distribution. AmerisourceBergen’s Innomar Strategies will handle medical information and pharmacovigilance, or the monitoring, detection and prevention of adverse events.
Outlook and AmerisourceBergen are also discussing a distribution agreement for outside the U.S.
Meanwhile, Visus Therapeutics on Wednesday announced it’s expanding its ophthalmic pipeline by acquiring the patents and assets of ViewPoint Therapeutics.
ViewPoint is developing an alpha-crystallin aggregation inhibitor as a non-surgical treatment for protein misfolding in the eye.
Misfolding causes cataracts and presbyopia, age-related near-sightedness. Presbyopia and cataracts are the leading causes of vision disability.
Alpha-crystallin aggregation inhibitors aim to restore lens clarity and have the potential to reverse near-sightedness and cataracts without surgery. Some 128 million U.S. adults have presbyopia. Most people treat age-related near-sightedness with reading glasses. More than half of U.S. adults older than 80 have cataracts.
Visus is currently conducting Phase III trials of its eye drops, Brimochol, for the treatment of presbyopia. Brimochol is a combination of carbachol and brimonidine tartrate. Carbachol is a miotic agent that constricts pupils.
“More than a third of the world’s population have presbyopia or cataracts, and this will only increase as the population ages,” said Dr. Eric Donnenfeld of Ophthalmic Consultants of New York and NYU. “A non-surgical approach to treating and possibly preventing cataracts and presbyopia could improve the quality of life of millions of people, globally, and would be a disruptive addition to the management of our patients.”
