EyePoint, Inc. has completed enrollment in the global COMO and CAPRI Phase 3 trials evaluating DURAVYU in diabetic macular edema. More than 480 treatment-naive and previously treated participants entered the two studies within five months, ahead of the company’s previous third-quarter enrollment target. The pivotal trials will test whether a 2.7 mg DURAVYU intravitreal insert administered every six months can preserve vision at least as effectively as on-label 2 mg aflibercept, with topline 56-week results expected in the fourth quarter of 2027.
Enrollment completion confirms that the studies have recruited their intended populations, but it does not provide new evidence that DURAVYU is effective or safe. The principal clinical test will be whether a sustained-release treatment can reduce the frequency of eye injections without sacrificing best-corrected visual acuity or allowing retinal swelling to return between doses.
COMO and CAPRI will compare six-month DURAVYU dosing with on-label aflibercept treatment
COMO and CAPRI are global, randomized, double-masked and aflibercept-controlled non-inferiority studies. Participants are assigned to receive either a 2.7 mg DURAVYU insert or the approved 2 mg dose of aflibercept. Patients in the DURAVYU groups are scheduled for repeat treatment every six months, while the control groups receive aflibercept according to its approved dosing regimen.
The primary endpoint is the blended change from baseline in best-corrected visual acuity at weeks 52 and 56. Blending measurements from two visits can reduce the influence of temporary fluctuations or an unusually strong or weak result recorded during a single examination. The trials are designed for non-inferiority, meaning DURAVYU does not need to produce greater visual improvement than aflibercept. It must remain within a predefined margin showing that substantially less frequent treatment does not cause an unacceptable loss of efficacy.
EyePoint has not disclosed the numerical non-inferiority margin in its July 30 announcement. That margin will be important when the results are reported because a trial can technically achieve non-inferiority even when the average outcome numerically favors the comparator, provided the difference remains within the prespecified boundary.
Secondary endpoints include safety, the reduction in treatment burden, the proportion of eyes requiring no supplemental aflibercept and anatomical changes measured through optical coherence tomography. OCT allows investigators to measure central retinal thickness and determine whether fluid is adequately controlled, even when visual acuity remains temporarily stable.
Participants may receive supplemental aflibercept if disease activity exceeds the trial’s rescue criteria. A high rescue-injection rate could allow average vision to remain acceptable while weakening the argument that DURAVYU provides dependable six-month disease control. The most clinically persuasive result would combine non-inferior vision, stable retinal anatomy, fewer injections and a large proportion of patients who do not need rescue therapy.
The studies include both treatment-naive patients and people previously treated for diabetic macular edema. This broader population should provide evidence that is more representative of retinal practice than a study restricted to one treatment history. Investigators will still need to determine whether outcomes are consistent between newly treated eyes and eyes that already responded to anti-VEGF injections.
Sustained vorolanib delivery is intended to control vascular leakage for six months
Diabetic macular edema develops when diabetes-related damage causes retinal blood vessels to leak fluid into the macula, the central retinal region needed for reading, driving and recognizing fine detail. The fluid causes retinal swelling and can produce blurred or distorted central vision. Anti-VEGF injections are the recommended first-line treatment for many patients with vision-impairing diabetic macular edema.
DURAVYU combines vorolanib, a small-molecule tyrosine kinase inhibitor, with EyePoint’s bioerodible Durasert E drug-delivery technology. The insert is administered through a standard intravitreal injection in a retinal specialist’s office and is designed to release vorolanib inside the eye for at least six months before gradually eroding.
Vorolanib acts inside cells to inhibit all vascular endothelial growth factor receptors rather than binding circulating VEGF molecules in the manner of aflibercept and other antibody-based therapies. EyePoint also reports that vorolanib inhibits platelet-derived growth factor receptors and affects inflammation through IL-6 and JAK1 signaling. The potential clinical importance of these additional actions has not been established in a completed Phase 3 diabetic macular edema trial.
Current 2 mg aflibercept dosing for diabetic macular edema generally involves injections every four weeks for the first five doses followed by dosing every eight weeks, although some patients require more frequent treatment. The 8 mg formulation can extend treatment to intervals of eight to 16 weeks after initial monthly loading doses. DURAVYU’s planned six-month interval would therefore represent a substantial reduction in scheduled injections if the Phase 3 studies confirm reliable disease control.
Longer intervals could reduce visits and procedures for patients who are often managing diabetes and other health conditions at the same time. Frequent anti-VEGF visits can burden patients, caregivers and treatment centers, while missed or delayed injections may allow retinal fluid to recur and vision to deteriorate. Sustained-delivery approaches are being investigated partly to reduce this gap between outcomes achieved in controlled trials and those reached during routine care.
Durability cannot be judged solely by the amount of drug released from the insert. Phase 3 must show that the concentration remaining late in each six-month interval is sufficient to control disease across patients with different levels of VEGF activity. Results around months five and six will be particularly informative because they should reveal whether anatomical or visual control weakens before the next scheduled dose.
Phase 2 VERONA results support the pivotal design but came from only 27 patients
The Phase 3 program was informed by the randomized Phase 2 VERONA study, which enrolled 27 patients with previously treated diabetic macular edema. Participants received 1.34 mg DURAVYU, 2.7 mg DURAVYU or aflibercept. The primary endpoint measured the time to the first supplemental aflibercept injection through week 24.
At week 24, the selected 2.7 mg DURAVYU dose produced an average gain of 7.1 best-corrected visual acuity letters from baseline and an average 75.9-micron reduction in central subfield thickness. Approximately 73% of eyes in the 2.7 mg group required no supplemental aflibercept through six months, compared with 50% of control eyes. EyePoint also reported that the dose reduced treatment burden by more than two-thirds.
The anatomical comparison favored DURAVYU, with EyePoint reporting 74% greater reduction in retinal thickness than in the aflibercept control group. Visual and anatomical improvements were observed by week four, suggesting that the solid insert released therapeutically active vorolanib soon after administration rather than requiring several months to reach useful exposure.
VERONA was too small to establish comparative efficacy reliably. Only 27 patients were divided among three treatment groups, including approximately 11 patients receiving the 2.7 mg dose and six receiving aflibercept. One or two unusual outcomes could therefore have had a substantial effect on the group averages.
The study was also described as randomized and controlled but included open-label features, and all participants had previously received anti-VEGF treatment. COMO and CAPRI use double masking and include treatment-naive patients, making them more rigorous tests of whether the Phase 2 results can be reproduced across a broader population.
No DURAVYU-related ocular or systemic serious adverse events were reported in VERONA through the six-month analysis. EyePoint reported no cases of endophthalmitis, retinal vasculitis, insert migration or intraocular inflammation. The small study could not rule out uncommon complications, particularly when the product is administered repeatedly to hundreds or potentially thousands of patients.
An independent data safety monitoring committee reviewed masked information from EyePoint’s ongoing wet age-related macular degeneration and diabetic macular edema Phase 3 programs in May 2026 and recommended that the studies continue without protocol changes. That recommendation indicates that the committee did not identify a safety concern requiring interruption or modification at that review. It does not provide unmasked safety rates or establish that DURAVYU will ultimately have an acceptable benefit-risk profile.
The 2027 readout must prove that fewer injections do not compromise visual outcomes
Completing enrollment ahead of schedule reduces recruitment uncertainty and makes the fourth-quarter 2027 data target more credible. It also means the remaining timeline is driven primarily by participant follow-up, data cleaning and analysis rather than by the ability to find eligible patients.
DURAVYU’s Phase 3 program now spans more than 1,380 participants across diabetic macular edema and wet age-related macular degeneration. More than 900 patients were enrolled in the LUGANO and LUCIA wet AMD trials, while COMO and CAPRI added more than 480 patients. The wet AMD studies are expected to begin reporting data in August 2026, more than a year before the diabetic macular edema results.
The wet AMD readouts may provide earlier information about repeat six-month dosing, intravitreal safety and manufacturing consistency. Positive results would increase confidence in the shared delivery platform, but they would not establish efficacy in diabetic macular edema because the diseases involve different populations, retinal pathology and treatment responses.
The diabetic macular edema studies must show that the insert performs across eyes with varying disease severity and prior exposure to treatment. Investigators will examine whether benefits are consistent between COMO and CAPRI, because two independently positive studies would provide stronger evidence than a result driven by one successful trial and one inconclusive trial.
Safety will remain critical for a sustained intraocular tyrosine kinase inhibitor. Investigators must monitor for inflammation, infection, retinal vasculitis, retinal detachment, changes in intraocular pressure, insert migration and systemic effects. Because the insert cannot simply be removed through a routine office procedure after injection, an unexpected local reaction could be more difficult to manage than a problem associated with a short-acting medicine.
Enrollment completion is therefore an operational milestone rather than a clinical conclusion. DURAVYU’s potential advantage is clear: two planned treatments per year could substantially reduce the injection schedule associated with diabetic macular edema. The pivotal results must now demonstrate that this convenience is achieved without weaker vision outcomes, inadequate late-interval disease control or safety problems associated with repeated sustained-release treatment.
