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FDA Rejects Outlook Therapeutics' Eye Drug for Third Time as Efficacy Questions Persist

MarketDash Editorial Team
2 hours ago
Outlook Therapeutics shares plunged to a 52-week low after the FDA issued another rejection letter for Lytenava, its wet AMD treatment, saying the company still hasn't provided enough proof the drug actually works.

Sometimes in biotech, the third time is not the charm. Outlook Therapeutics, Inc. (OTLK) learned that lesson the hard way on Friday when its stock plummeted to a new 52-week low after the FDA once again rejected its application for Lytenava, a treatment for wet age-related macular degeneration.

The FDA issued a complete response letter (CRL) on Wednesday to Outlook's resubmission of its biologics license application for ONS-5010/Lytenava (bevacizumab-vikg). The message was clear: the agency cannot approve the application in its current form. The problem? Still not enough evidence that the drug actually works.

A Pattern of Rejection

This marks the third time Outlook has hit a wall with regulators over this eye drug. Back in August 2023, the FDA sent the company its first complete response letter regarding ONS-5010. Then in August 2025, another CRL arrived with a single deficiency: lack of substantial evidence of effectiveness.

Now, despite Outlook's efforts to address those concerns, the FDA says the additional mechanistic and natural history data provided in the latest resubmission don't change the previous conclusion. The company submitted a complete data set from its NORSE clinical trial program, but it wasn't enough to move the needle.

The Efficacy Puzzle

Here's the frustrating part for Outlook: the FDA acknowledges that one adequate and well-controlled study demonstrated efficacy. But the agency wants confirmatory evidence to support the application. The catch? The FDA hasn't indicated what type of confirmatory evidence would actually be acceptable. That's like being told to improve your performance without being given the scoring rubric.

Wet AMD is serious business. It's a severe form of age-related macular degeneration where abnormal blood vessels grow under the retina, leaking blood and fluid. This causes rapid central vision loss, with patients experiencing wavy lines, dark spots, or blurred vision. Effective treatments are critically needed, which makes regulatory setbacks in this space particularly disappointing for patients and investors alike.

What's Next for Outlook?

Outlook Therapeutics isn't throwing in the towel yet. The company says it's exploring all available pathways for potential approval in the U.S. Meanwhile, it intends to continue efforts to expand into additional markets in Europe and other regions. Whether those international regulatory bodies will be more receptive to the existing data remains to be seen.

Rough Times for Wet AMD Treatments

Outlook isn't alone in struggling with wet AMD drug development. In March 2025, Opthea Limited (OPT) announced that its global Phase 3 COAST trial for wet AMD failed to meet its primary endpoint of mean change in best corrected visual acuity from baseline to week 52.

That trial evaluated intravitreally administered 2 mg sozinibercept every four or eight weeks in combination with 2 mg of Regeneron Pharmaceuticals Inc.'s (REGN) Eylea (aflibercept), administered every eight weeks after a loading phase. The setback highlighted just how challenging this therapeutic area can be.

Market Reaction

Investors didn't wait around for the details. Outlook Therapeutics shares plunged 60.82% to $0.61 during premarket trading on Friday, marking a new 52-week low. When a company gets rejected by the FDA three times for the same drug, with no clear path forward and vague guidance on what would satisfy regulators, the market tends to lose patience quickly.

The big question now is whether Outlook can figure out what the FDA actually wants to see or if the company will need to pivot its strategy entirely. With the stock trading near pennies and regulatory uncertainty hanging overhead, time isn't exactly on their side.

Back to Stock Market News

FDA Rejects Outlook Therapeutics' Eye Drug for Third Time as Efficacy Questions Persist

MarketDash Editorial Team
2 hours ago
Outlook Therapeutics shares plunged to a 52-week low after the FDA issued another rejection letter for Lytenava, its wet AMD treatment, saying the company still hasn't provided enough proof the drug actually works.

Sometimes in biotech, the third time is not the charm. Outlook Therapeutics, Inc. (OTLK) learned that lesson the hard way on Friday when its stock plummeted to a new 52-week low after the FDA once again rejected its application for Lytenava, a treatment for wet age-related macular degeneration.

The FDA issued a complete response letter (CRL) on Wednesday to Outlook's resubmission of its biologics license application for ONS-5010/Lytenava (bevacizumab-vikg). The message was clear: the agency cannot approve the application in its current form. The problem? Still not enough evidence that the drug actually works.

A Pattern of Rejection

This marks the third time Outlook has hit a wall with regulators over this eye drug. Back in August 2023, the FDA sent the company its first complete response letter regarding ONS-5010. Then in August 2025, another CRL arrived with a single deficiency: lack of substantial evidence of effectiveness.

Now, despite Outlook's efforts to address those concerns, the FDA says the additional mechanistic and natural history data provided in the latest resubmission don't change the previous conclusion. The company submitted a complete data set from its NORSE clinical trial program, but it wasn't enough to move the needle.

The Efficacy Puzzle

Here's the frustrating part for Outlook: the FDA acknowledges that one adequate and well-controlled study demonstrated efficacy. But the agency wants confirmatory evidence to support the application. The catch? The FDA hasn't indicated what type of confirmatory evidence would actually be acceptable. That's like being told to improve your performance without being given the scoring rubric.

Wet AMD is serious business. It's a severe form of age-related macular degeneration where abnormal blood vessels grow under the retina, leaking blood and fluid. This causes rapid central vision loss, with patients experiencing wavy lines, dark spots, or blurred vision. Effective treatments are critically needed, which makes regulatory setbacks in this space particularly disappointing for patients and investors alike.

What's Next for Outlook?

Outlook Therapeutics isn't throwing in the towel yet. The company says it's exploring all available pathways for potential approval in the U.S. Meanwhile, it intends to continue efforts to expand into additional markets in Europe and other regions. Whether those international regulatory bodies will be more receptive to the existing data remains to be seen.

Rough Times for Wet AMD Treatments

Outlook isn't alone in struggling with wet AMD drug development. In March 2025, Opthea Limited (OPT) announced that its global Phase 3 COAST trial for wet AMD failed to meet its primary endpoint of mean change in best corrected visual acuity from baseline to week 52.

That trial evaluated intravitreally administered 2 mg sozinibercept every four or eight weeks in combination with 2 mg of Regeneron Pharmaceuticals Inc.'s (REGN) Eylea (aflibercept), administered every eight weeks after a loading phase. The setback highlighted just how challenging this therapeutic area can be.

Market Reaction

Investors didn't wait around for the details. Outlook Therapeutics shares plunged 60.82% to $0.61 during premarket trading on Friday, marking a new 52-week low. When a company gets rejected by the FDA three times for the same drug, with no clear path forward and vague guidance on what would satisfy regulators, the market tends to lose patience quickly.

The big question now is whether Outlook can figure out what the FDA actually wants to see or if the company will need to pivot its strategy entirely. With the stock trading near pennies and regulatory uncertainty hanging overhead, time isn't exactly on their side.