Full Press Release Details
Ocular Therapeutix Reports Second Quarter
2025 Financial Results and Business Highlights
Outstanding patient retention and clinical execution
in complementary AXPAXLI SOL trials for wet AMD
SOL-1 remains on track for 1Q 2026 topline data
SOL-R rescue criteria streamlined and simplified
with topline data expected in 1H 2027
Planning to incorporate single long-term extension
study for both SOL trials
Ocular to host Investor Day on Tuesday, September
30, 2025, in New York City
Raised gross proceeds of approximately $97 million
in June 2025 through existing ATM facility
Cash balance of $391
million as of June 30, 2025, with expected runway into 2028, well beyond anticipated topline data for SOL-1 and SOL-R
BEDFORD, MA, August 5, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix,
Inc. (NASDAQ: OCUL, "Ocular"), an integrated biopharmaceutical company committed to redefining the retina experience,
today reported financial results for the second quarter ended June 30, 2025, and provided recent business highlights.
"We are entering the most important phase of Ocular
Therapeutix's history, marked by consistent execution, growing clinical conviction, and a clear roadmap to redefine the retina
treatment landscape," said Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of
Ocular Therapeutix. "With SOL-1 on track for topline data in the first quarter of 2026, followed by SOL-R topline data in the
first half of 2027, we are building what we expect to be a powerful and highly differentiated clinical profile for AXPAXLI. Due to
our increasing confidence and conviction in AXPAXLI's potential, we are now planning a long-term, open-label extension study
for patients completing either of the SOL trials, and we are advancing SOL-R with streamlined and simplified rescue criteria that
better reflect real-world practice. SOL-1 and SOL-R are thoughtfully crafted, complementary trials with bespoke patient populations
designed to de-risk outcomes and answer key questions physicians will have on the durability, flexibility, and repeatability of
AXPAXLI. As a result of this clinical strategy, AXPAXLI has the potential to secure an unprecedented superiority label in wet AMD.
Recently approved anti-VEGF products and current competitive Phase 3 wet AMD trials are all based on non-inferiority to aflibercept
(2 mg). To our knowledge, SOL-1 is the only Phase 3 superiority trial being conducted in wet AMD, and if we are successful in
gaining FDA approval, we will potentially be the only product with a superiority claim in the label for the foreseeable future. We
further expect the SOL program to enable dosing every 6 months to as infrequently as every 12 months. We believe this dynamic will
allow us a unique and potentially dominant position compared to all other products in the commercial landscape, and could unlock an
opportunity that spans millions of patients worldwide - addressing the critical needs for a more sustainable, less burdensome
treatment, with potentially improved long-term outcomes."
Dr. Dugel continued, "Beyond wet AMD, we are thrilled
with the FDA feedback supporting our NPDR and DME program, and we look forward to sharing more details at our Investor Day in September,
along with the global commercial outlook for AXPAXLI and more. Our refreshed corporate branding, launched in June, reflects the Company
we've become: retina-focused, patient-driven, and boldly advancing a potential new standard-of-care in retinal disease."
Recent Achievements and Upcoming Milestones:
| SOL-1 (Phase 3, wet AMD) retention and protocol adherence continues to be exceptional as topline data remains on track for 1Q 2026. Patient engagement and investigator adherence to the study rescue protocol continue to be outstanding in the SOL-1 superiority study. Ocular plans to continue to follow patients completing the trial through a long-term extension study. | ||
| SOL-R (Phase 3, wet AMD) rescue criteria streamlined and simplified with topline data expected in 1H 2027. The SOL-R non-inferiority study is the largest tyrosine kinase inhibitor (TKI) trial to date in retina. Based on investigator feedback, and as part of its ongoing effort to ensure SOL-R reflects real-world clinical decision-making, Ocular has streamlined and simplified the rescue criteria to a >5-letter loss in visual acuity plus a 75-micron increase in central subfield thickness (CSFT). This change aligns the trial more closely with how physicians determine when to intervene in the real world in the most conservative manner. This change was not an FDA requirement, but rather a strategic decision to further bridge the gap between clinical trial design and clinical practice. SOL-R remains robustly powered at 90% with the non-inferiority margin of -4.5 ETDRS letters per FDA guidance. SOL-R has completed enrollment and, based on its projected randomization timeline, Ocular expects to report topline data in 1H 2027. | ||
| New Drug Application (NDA) filing for FDA review planned for shortly after topline results in SOL-R. Because axitinib is FDA-approved for non-ophthalmic indications, the Company plans to leverage the 505(b)(2) NDA review pathway which has the potential to shorten the review timeline for AXPAXLI by two months compared to the traditional review pathway for new molecular entities. The FDA has previously communicated that SOL-1 and SOL-R should be appropriate for use as adequate and well-controlled studies to support a potential NDA and product label for wet AMD. If approved, Ocular believes AXPAXLI has the potential to be the first product for wet AMD with a superiority label based on the SOL-1 trial, with redosing potentially as infrequently as every 12 months. |
| The Company plans to incorporate a single long-term, open-label extension study for both SOL trials. Subjects will be eligible to enter the extension study after completing the two-year safety follow-up period in either SOL-1 or SOL-R. In addition to providing long-term safety data, the study is expected to further inform the AXPAXLI treatment paradigm and potentially provide several commercial advantages. The extension study is designed to evaluate long-term safety and explore key efficacy outcomes such as vision preservation, anti-fibrotic activity, and the potential consequences of delaying AXPAXLI treatment in control arm patients. | ||
| Written feedback received from FDA on registrational trial in non-proliferative diabetic retinopathy (NPDR) for AXPAXLI . Building on FDA's positive feedback received earlier this year, Ocular is actively engaged in defining its clinical strategy for AXPAXLI in NPDR and diabetic macular edema (DME). The Company plans to provide more details surrounding its clinical trial strategy and design at its upcoming Investor Day on September 30, 2025. | ||
| Opportunistically raised gross proceeds of approximately $97 million in June 2025 through existing at-the-market (ATM) facility. This additional capital provides Ocular with financial flexibility as the Company prepares for data from its first registrational trial in wet AMD, SOL-1, in the first quarter of 2026. Ocular remains well-financed with expected runway well beyond the anticipated receipt of SOL-1 and SOL-R topline data and into 2028. | ||
| Investor Day to be held the afternoon of Tuesday, September 30, 2025, in New York City. The event will feature prominent retinal disease Key Opinion Leaders (KOLs) and presentations from senior Company leadership. Key areas of focus include: an overview of the complementary SOL trials and how they may support a differentiated superiority label for AXPAXLI in wet AMD; new details on the planned SOL extension study; the clinical strategy for NPDR and DME informed by recent FDA feedback; and a review of the global commercial opportunity for AXPAXLI across retinal indications. Additional event logistics and webcast information will be provided in advance. To register for Ocular's Investor Day, please visit Ocular's website or register HERE. | ||
| Unveiled new corporate branding in June 2025 reflecting Ocular's transformation to a retina-focused company. Ocular aims to redefine the retina experience by reducing the treatment burden and providing an alternative to the pulsatile nature of available treatments, in hopes of preserving vision for the long-term. The Company's new branding reflects Ocular's meaningful progress, driven by the momentum of its SOL trials and its commitment to patients. |
Second Quarter Ended June 30, 2025, Financial Results:
Total cash and cash equivalents were $391.1 million
as of June 30, 2025. Based on current plans and related estimates of anticipated cash inflows from DEXTENZA , the Company
believes that its current cash balance is sufficient to support its planned expenses, debt service obligations, and capital expenditure
requirements into 2028. This cash projection does not yet factor in the full impact of potential clinical trial activities for AXPAXLI
in NPDR and DME or the long-term extension study in wet AMD, as Ocular is currently in the planning phases for these programs.
Total net revenue was $13.5 million for
the second quarter of 2025, an 18.1% decrease as compared to total net revenue of $16.4 million in the comparable quarter in 2024. Total
net revenue includes both gross DEXTENZA product revenue, net of discounts, rebates, and returns, which the Company refers to as net product
revenue, and collaboration revenue.
DEXTENZA end-user unit sales were up 5% compared to the second
quarter in 2024, however the reduction in net revenue was due to an evolving and significantly more challenging reimbursement environment
for DEXTENZA in 2025. Strong execution by the Ocular commercial team has ensured the demand for DEXTENZA continues to grow, as evidenced
by sustained unit growth. Compared to the first quarter of 2025, DEXTENZA net product revenue increased by 26.0% in the second quarter
Research and development expenses for the second quarter
of 2025 were $51.1 million versus $28.9 million for the comparable quarter in 2024, reflecting an increase in overall clinical expenses
associated with the SOL-1 and SOL-R Phase 3 clinical trials, as well as additional personnel and professional services to support these
Selling and marketing expenses were $13.7 million
for the second quarter of 2025, as compared to $10.0 million for the comparable quarter of 2024, primarily reflecting an increase in personnel-related
costs, including stock-based compensation expense, and professional fees associated with pre-commercialization activities for AXPAXLI.
General and administrative expenses were $14.3 million
for the second quarter of 2025, as compared to $19.7 million for the comparable quarter of 2024, primarily due to a decrease in personnel-related
costs, including stock-based compensation expense. The second quarter of 2024 includes one-time personnel-related costs, including stock-based
compensation expense, for certain employees who departed the Company, and restructuring costs.
Net loss for the second quarter of 2025 was $(67.8)
million, or a net loss of $(0.39) per share on both a basic and diluted basis, compared to a net loss of $(43.8)
million, or a net loss of $(0.26) per share on a basic and diluted basis, for the comparable quarter of 2024. The net loss
in the second quarter of 2025 includes a net loss from the change in fair value of our derivative liability of $(0.6) million, which
is comprised of a non-cash loss from fair value measurement of the derivative liability associated with the Barings Credit Facility
of $(0.2) million, and expense related to actual royalty fees under the Barings Credit Facility of $(0.5) million, compared to a
$(3.0) million net loss for the second quarter of 2024, which is comprised of a net non-cash loss attributable to fair value
measurements of the derivative liabilities associated with the Barings Credit Facility and the Company's convertible notes of $(2.5)
million, and expense related to actual royalty fees under the Barings Credit Facility of $(0.6) million.
Outstanding shares as of August 1, 2025, were
approximately 174.0 million.
Conference Call and Webcast Information:
Ocular Therapeutix will host a conference call and webcast on Tuesday,
August 5, 2025, at 8:00 AM ET to discuss recent business progress and financial results for the second quarter ended June 30, 2025. To
access the call, please dial: 1-877-407-9039 (U.S.) or 1-201-689-8470 (International). The live and archived webcast can also be
accessed by visiting the Ocular Therapeutix website on the Events and Presentations section of the Investor Relations page. A replay of
the webcast will be archived for at least 30 days.
AXPAXLI (also known as OTX-TKI) is an investigational, bioresorbable, intravitreal hydrogel incorporating axitinib, a small
molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD, diabetic
retinopathy, diabetic macular edema, and other retinal diseases.
About the SOL-1 Study
The registrational Phase 3 SOL-1 trial (NCT06223958) is designed to evaluate the safety and efficacy of AXPAXLI in a multi-center,
double-masked, randomized (1:1), parallel group study that involves more than 100 clinical trial sites located in the U.S. and Argentina.
In December 2024, the trial completed randomization of 344 evaluable treatment-na ve subjects with a diagnosis of wet AMD in the
The superiority study has an eight-week loading segment prior to randomization.
During the loading segment, subjects who have 20/80 vision or better and who satisfy other enrollment criteria receive two doses of aflibercept
(2 mg) at Week -8 and Week -4. Eligible subjects who achieve best corrected visual acuity (BCVA) of 20/20 at Day 1 or gain at least 10
early treatment diabetic retinopathy study (ETDRS) letters at Day 1 are then randomized to receive a single dose of AXPAXLI or a single
dose of aflibercept (2 mg). At Week 52 and at Week 76, all subjects are re-dosed with their respective initial treatment of AXPAXLI or
aflibercept (2 mg). Subjects will be followed for safety until the end of Year 2. Throughout the study, subjects are assessed monthly.
Trial subjects and designated study personnel will remain masked through the end of Year 2. The clinical trial protocol requires that,
during the study, subjects in either arm meeting pre-specified rescue criteria will receive a supplemental dose of aflibercept (2 mg).
The primary endpoint of SOL-1 is the proportion of subjects who maintain
visual acuity, defined as a loss of <15 ETDRS letters of BCVA, at Week 36. Subjects will continue to be evaluated for durability up