The FDA acknowledged receipt of the application on Tuesday. If approved, ONS-5010/LYTENAVA would become the first FDA-approved ophthalmic formulation of bevacizumab.The agency classified the filing as a Class 1 review and set a target action date of July 29.Previous Rejections For Outlook Therapeutics Eye DrugIn January, the FDA issued a complete response letter (CRL) to Outlook Therapeutics' resubmission of the biologics license application (BLA) for ONS-5010/Lytenava (bevacizumab-vikg).The letter indicated that the FDA cannot approve the application in its present form for wet age-related macular degeneration (wet AMD).By April, Outlook Therapeutics submitted a formal dispute resolution request (FDRR) to the FDA regarding its ONS-5010/LYTENAVA.Last August, the FDA issued a CRL to ONS-5010 resubmission. The CRL included only one deficiency for a lack of substantial evidence of effectiveness.In August 2023, Outlook Therapeutics received a complete response letter from the FDA regarding ONS-5010.Technical OutlookThe stock has shown a 12-month performance decline of 7.10%, but recent price action indicates a strong upward momentum.Currently, the stock is trading at $1.64, which is significantly above its 20-day SMA of 75 cents, indicating bullish sentiment, with the price sitting 119.9% above this moving average.Momentum indicators show the Relative Strength Index (RSI) at 86.22, suggesting the stock is overbought and could trigger a near-term pullback.This high RSI level reflects a strong upward trend, but it also raises caution for investors as it may signal that the stock is stretched.
Outlook Therapeutics Eye Drug Review Returns To FDA — Again - Outlook Therapeutics (NASDAQ:OTLK)
Outlook Therapeutics shares rose after the FDA accepted its resubmitted LYTENAVA BLA and set a July 2026 target action date.











