Regulatory oversight appears to be shifting for an ophthalmology program: Outlook Therapeutics said FDA reversed course on its reformulated version of Avastin for wet age-related macular degeneration (wet AMD) after multiple rejections dating to 2023. The company said the agency concluded that substantial evidence supports the needed changes. The development matters for stakeholders because Outlook’s application strategy hinges on FDA feedback at the formula level, which can determine whether trials or commercialization plans need retooling. A new clearance pathway would also affect competitive dynamics in retina. Watch for downstream FDA communication on timing and what additional datasets may be required before broader use.