EyePoint Announces 53% Workforce Reduction Following Phase 3 DURAVYU Trial Results

EyePoint, Inc. (NASDAQ:EYPT) announced plans to reduce its workforce by approximately 53% and conclude its pivotal Phase 3 clinical trials in wet age-related macular degeneration (AMD) earlier than planned after its investigational treatment DURAVYU failed to meet the primary endpoint in the LUCIA study.

The Massachusetts-based biotechnology company said its board of directors approved a restructuring programme intended to reduce operating expenses and preserve capital while redirecting resources towards its Phase 3 development programme for DURAVYU in diabetic macular oedema (DME).

EyePoint expects the restructuring to generate approximately $30 million in annualised savings, with one-time employee-related charges estimated at $9 million.

Phase 3 LUCIA Study Does Not Meet Primary Endpoint

The LUCIA trial evaluated DURAVYU as a potential treatment for wet age-related macular degeneration, a condition characterised by abnormal blood vessel growth in the retina that can cause vision loss.

The study did not achieve its primary endpoint of non-inferiority, which was designed to assess whether DURAVYU could demonstrate efficacy within a predefined margin compared with the reference treatment.

Failure to meet this endpoint means the trial did not establish the required evidence of non-inferiority under its prespecified statistical criteria.

However, EyePoint reported that patients receiving DURAVYU experienced improvements in vision during the study.

The company also stated that the trial achieved secondary endpoints relating to reduced treatment burden and anatomical control.

These findings suggest that some measures of treatment activity were observed despite the primary endpoint not being met.

Nevertheless, the results did not satisfy the study’s principal efficacy objective, prompting EyePoint to end its pivotal wet AMD programme earlier than planned.

DURAVYU remains an investigational treatment and has not received approval from the US Food and Drug Administration (FDA).

Company Shifts Development Focus to Diabetic Macular Oedema

Following the LUCIA results, EyePoint plans to concentrate its clinical development activities on DURAVYU for diabetic macular oedema.

DME is a retinal condition associated with diabetes in which fluid accumulates in the macula, potentially affecting central vision.

EyePoint’s Phase 3 DME programme consists of two pivotal clinical trials, COMO and CAPRI.

The studies have enrolled a combined total of 551 patients.

Both trials are evaluating DURAVYU at a dose of 2.7 mg administered every six months, compared with aflibercept administered every eight weeks.

Aflibercept is an established treatment used for several retinal conditions, including diabetic macular oedema.

The trials are intended to assess whether DURAVYU can provide an alternative treatment approach with less frequent administration.

EyePoint expects topline results from both studies during the fourth quarter of 2027.

The clinical outcomes remain uncertain, and the company has not reported efficacy results from these Phase 3 DME trials.

Workforce Reduction Expected to Continue Into 2027

EyePoint’s board approved a restructuring plan that includes eliminating approximately 53% of the company’s workforce.

The reductions are expected to take place substantially during the fourth quarter of 2026, with the process scheduled for completion during the first half of 2027.

The company estimates that it will incur approximately $9 million in one-time charges associated with employee severance and other separation benefits.

Once implemented, the restructuring is expected to reduce annual operating costs by approximately $30 million.

The projected savings reflect management estimates and will depend on the timing and execution of the workforce reductions.

EyePoint did not disclose the total number of employees affected or provide a detailed breakdown of the reductions by department in the information released.

The restructuring follows the decision to discontinue the pivotal wet AMD studies and concentrate available resources on the remaining DME development programme.

Chief Executive Comments on Restructuring

Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint, acknowledged the impact of the workforce reduction on employees.

“Decisions involving a reduction in our workforce are exceptionally difficult, and we extend our deepest gratitude to our departing colleagues for their dedication and meaningful contributions,” Duker said.

The restructuring forms part of the company’s response to the LUCIA trial outcome and its decision to prioritise the diabetic macular oedema programme.

EyePoint expects the reduction in operating expenses to support the continued development of DURAVYU while limiting future cash expenditure.

Cash and Investments Total Approximately $118 Million

EyePoint reported cash, cash equivalents and short-term investments of approximately $118 million as of 30 September 2026.

The company intends to preserve financial resources through its restructuring programme and the early conclusion of its wet AMD clinical trials.

The anticipated $30 million in annualised savings may reduce future operating expenditure, although the company will incur approximately $9 million in one-time restructuring charges.

The available information does not include updated cash runway guidance or a detailed forecast of expenditure through the expected DME trial readouts in late 2027.

EyePoint’s future funding requirements will depend on clinical development costs, restructuring expenses and other operational commitments.

DURAVYU Development Continues Without FDA Approval

DURAVYU is being investigated as a potential treatment for retinal diseases requiring ongoing management.

The failure of the LUCIA study to demonstrate non-inferiority in wet AMD represents a setback for that particular development programme, although EyePoint reported improvements in vision and achievement of certain secondary endpoints.

The company has elected to continue development in diabetic macular oedema through the COMO and CAPRI studies.

The two Phase 3 trials will provide additional evidence about DURAVYU’s efficacy and safety in this separate indication.

DURAVYU has not been approved by the FDA for wet AMD, DME or any other indication.

Any future regulatory submission would depend on the results of clinical development and the applicable regulatory requirements.

Investors Await Phase 3 DME Results in 2027

EyePoint’s restructuring follows the unsuccessful primary endpoint outcome in its Phase 3 LUCIA trial and represents a reduction in the company’s planned clinical development activities.

The company is targeting approximately $30 million in annualised savings while continuing its two pivotal studies in diabetic macular oedema.

With 551 patients enrolled across COMO and CAPRI, the next major clinical milestones are the expected topline results in the fourth quarter of 2027.

Investors will be monitoring the implementation of the workforce reductions, cash expenditure and progress of the remaining clinical programme.

The company’s longer-term development plans will depend substantially on the outcome of the DME trials and its ability to maintain sufficient financial resources.

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