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# An Eye Drug Failed Its Main Test — Now Its Maker Wants to Exclude Nine Patients
- URL: https://www.pennystocks.news/eypt-an-eye-drug-failed-its-main-test-now-its-maker-wants-to/
- Published: 2026-08-21T02:47:48.000Z
- Updated: 2026-08-21T02:47:48.000Z
- Description: DURAVYU didn't hit its primary goal in the LUGANO trial. EyePoint says nine patients who lost vision from unrelated causes skewed the result. Not one patient in the comparison group had the same problem.
- Author: PennyStocksNews Team
- Tags: nasdaq, ticker-eypt

Nine patients in EyePoint's Phase 3 eye drug trial lost significant vision. The company says none of them should count. **The primary endpoint was not achieved in the full patient dataset**, EyePoint said in an August 17 press release — but it is pushing ahead toward an FDA filing anyway.

EyePoint, Inc. NASDAQ: EYPT 

The LUGANO trial tested whether DURAVYU, an investigational implant delivered into the eye every six months, could match the vision outcomes of aflibercept, the standard injection treatment for wet age-related macular degeneration. Wet AMD damages central vision progressively and is a leading cause of blindness in people over fifty. **Nine patients in the DURAVYU arm lost significant vision** from geographic atrophy, glaucoma, and retinal detachment — not from wet AMD itself, according to EyePoint. All nine had their wet AMD controlled by the drug. **Not one patient in the aflibercept comparison arm experienced comparable losses.**

What this means for someone holding the stock: the case for FDA approval now rests largely on whether regulators accept an argument that was not part of the original trial design. EyePoint ran what it calls an ad hoc analysis — conducted after the results came in, rather than planned in advance — stripping those nine patients out. With them removed, the drug was non-inferior to aflibercept. Regulators draw a clear line between pre-specified and after-the-fact analyses, and EyePoint has not said whether the FDA has given any indication it will accept this framing.

Shares closed 15.17% higher at $6.3000 on August 19, on dollar volume of about $53 million.

EyePoint points to its secondary results as supporting evidence. Patients receiving DURAVYU needed **42% fewer supplemental injections** than those on aflibercept — a statistically superior result, the company said. **More than half of DURAVYU patients went 56 weeks without any supplemental treatment at all**, and in those patients specifically, vision outcomes were non-inferior to aflibercept. The drug's six-month dosing interval compares to the roughly every-two-month standard in current U.S. practice, according to the release.

EyePoint also argues the comparison arm performed better than expected historically — prior large trials showed roughly 3 to 5 percent of aflibercept patients typically lose significant vision, yet none did in LUGANO — which it says made the primary endpoint harder for DURAVYU to clear.

A second, identical trial called LUCIA is now the critical variable. Results are expected in the fourth quarter of 2026, and EyePoint says it still plans to file for FDA approval in the first half of 2027, assuming LUCIA supports that path. The company has not said what it would do if LUCIA also misses the primary endpoint on the full dataset.