Ocular Therapeutix Has Received FDA Written Response That Phase 3 Sol-r Trial Is Appropriate For Use As The Company's Second Adequate And Well Controlled Study Of Axpaxli (Axitinib Intravitreal Implant, Also Known As OTX-TKI) For Wet Age-related Macular Degeneration
Portfolio Pulse from Benzinga Newsdesk
Ocular Therapeutix has received a written response from the FDA indicating that the Phase 3 Sol-r trial is appropriate for use as the company's second adequate and well-controlled study of Axpaxli (Axitinib Intravitreal Implant, also known as OTX-TKI) for wet age-related macular degeneration.
August 07, 2024 | 11:10 am
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
Ocular Therapeutix has received FDA approval for the Phase 3 Sol-r trial as a second study for Axpaxli (OTX-TKI) in treating wet age-related macular degeneration.
The FDA's approval for the Phase 3 Sol-r trial as a second study for Axpaxli (OTX-TKI) is a significant regulatory milestone for Ocular Therapeutix. This approval could accelerate the development and potential commercialization of the treatment, positively impacting OCUL's stock price in the short term.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100