Earnings summaries and quarterly performance for OCULAR THERAPEUTIX.
Executive leadership at OCULAR THERAPEUTIX.
DN
Donald Notman
Detailed
Chief Financial Officer and Chief Operating Officer
JH
Jeffrey Heier
Detailed
Chief Scientific Officer
NW
Nadia Waheed
Detailed
Chief Medical Officer
PK
Peter Kaiser
Detailed
Chief Development Officer
PD
Pravin Dugel
Detailed
Executive Chairman
SN
Sanjay Nayak
Detailed
Chief Strategy Officer
TA
Todd Anderman
Detailed
Chief Legal Officer and Secretary
Board of directors at OCULAR THERAPEUTIX.
Research analysts who have asked questions during OCULAR THERAPEUTIX earnings calls.
Sean McCutcheon
Raymond James
6 questions for OCUL
Also covers: BMY, CMPX, CRIS +6 more
TA
Tazeen Ahmad
Bank of America
6 questions for OCUL
Also covers: ACAD, ALNY, APLS +20 more
TB
Tara Bancroft
TD Cowen
5 questions for OCUL
Also covers: ADVM, CELC, DAWN +10 more
YC
Yi Chen
H.C. Wainwright & Co.
5 questions for OCUL
Also covers: ANGO, APDN, BLFS +22 more
Biren Amin
Piper Sandler Companies
4 questions for OCUL
Also covers: ALLO, APLS, BBIO +5 more
CH
Colleen Hanley
Baird
2 questions for OCUL
Also covers: AGEN, CHRS, KPTI +1 more
CK
Colleen Kusy
Robert W. Baird & Co.
2 questions for OCUL
Also covers: APLS, BPMC, CHRS +5 more
DS
Dingding Shi
Jefferies
2 questions for OCUL
Also covers: ADCT, ASND, AUTL +6 more
Gregory Harrison
Scotiabank
2 questions for OCUL
Also covers: AGIO, APLS, EYPT +3 more
JW
Jon Wolleben
Citizen JMP
2 questions for OCUL
Also covers: BCRX, CLSD, MDGL +3 more
BM
Bill Maughan
Clear Street
1 question for OCUL
Also covers: DCTH, RGNX
C
Catherine
Citizens
1 question for OCUL
Also covers: KALV
CO
Catherine Okoukoni
Citizens JMP Securities, LLC
1 question for OCUL
Also covers: ALT
Catherine Okoukoni
Citizens JMP
1 question for OCUL
Also covers: ALT, CRNX, KALV +2 more
CC
Colleen Coozy
Baird
1 question for OCUL
Joe Thomas
Scotiabank
1 question for OCUL
Also covers: APLS, TVTX
JW
Jonathan Wolleben
JMP Securities, a Citizens Company
1 question for OCUL
Also covers: ALT, BCRX, CLSD +5 more
Kelly Shi
Jefferies
1 question for OCUL
Also covers: ADCT, AGEN, ALDX +17 more
LH
Lachlan Hanbury-Brown
William Blair & Company
1 question for OCUL
Also covers: APLS, ARSP, EYEN +4 more
LW
Lisa Walter
RBC Capital Markets
1 question for OCUL
Also covers: APLS, EYPT, RGNX +2 more
YC
Ye Chen
HC Wainwright
1 question for OCUL
YD
Yuxi Dong
Mizuho Securities
1 question for OCUL
Also covers: BGNE, HRTX, RVMD
Recent press releases and 8-K filings for OCUL.
OCULAR THERAPEUTIX to Submit AXPAXLI NDA Based on Year 1 SOL-1 Data
OCUL
Guidance Update
Product Launch
- OCULAR THERAPEUTIX, INC. (OCUL) intends to submit a new drug application (NDA) for its product candidate AXPAXLI (OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD).
- This submission will be based on year 1 data from the SOL-1 Phase 3 clinical trial, departing from the historical FDA requirement of two clinical trials for such ophthalmic product candidates.
- The company expects to report top-line data from year 1 of the SOL-1 clinical trial during the first quarter of 2026.
Dec 5, 2025, 10:17 PM
Ocular Therapeutix CEO Details AXPAXLI Clinical Timelines and Superiority Label Goals
OCUL
New Projects/Investments
Product Launch
- Ocular Therapeutix expects the readout of its first Phase III study, SOL-1, for AXPAXLI in the first quarter of 2026, with the goal of obtaining a superiority label.
- The second Phase III study, SOLAR, is anticipated to read out in the first half of 2027 , and together with SOL-1, aims to provide a label with dosing flexibility of every six to twelve months with repeatability.
- The company has secured an IP extension for AXPAXLI until 2044.
- Ocular Therapeutix is also pursuing the NPDR opportunity, where AXPAXLI could potentially offer an injection once a year.
Dec 3, 2025, 1:30 PM
Ocular Therapeutix Provides Update on AXPAXLI Phase III Trials and IP Extension
OCUL
New Projects/Investments
Guidance Update
- Ocular Therapeutix expects the readout for its SOL-1 Phase III study for AXPAXLI in Q1 2026, with the primary goal of obtaining a superiority label.
- The SOL-R Phase III study for AXPAXLI is anticipated to read out in the first half of 2027, designed to provide clinical relevance, demonstrate repeatability, and offer a comparison against high-dose EYLEA.
- The company holds an IP extension for AXPAXLI until 2044.
- Ocular Therapeutix is also pursuing the NPDR (Diabetic Retinopathy) opportunity with AXPAXLI, targeting a once-a-year injection and utilizing a novel ordinal endpoint validated by the FDA.
Dec 3, 2025, 1:30 PM
Ocular Therapeutix Provides Update on AXPAXLI Clinical Trials and Market Strategy
OCUL
New Projects/Investments
Product Launch
- Ocular Therapeutix is focused on retina and developing AXPAXLI, a TKI on a tunable hydrogel platform, to address treatment sustainability and long-term outcomes in retinal vascular diseases by targeting VEGF.
- The company has two Phase III studies for AXPAXLI: SOL-1, aiming for a superiority label in wet macular degeneration, with readout expected in Q1 2026, and SOLAR, designed for clinical relevance and non-inferiority against Eylea, with readout in H1 2027.
- AXPAXLI's target product profile includes a superiority label, dosing flexibility of six to twelve months with repeatability, and a durability of nine to ten months. The company's IP extension has been granted until 2044.
- Ocular Therapeutix identifies a significant opportunity in diabetic retinopathy (NPDR), where AXPAXLI could offer a once-a-year injection to potentially reduce vision-threatening complications from 30-40% to zero, addressing the current underutilization of anti-VEGFs in this patient population.
Dec 3, 2025, 1:30 PM
Ocular Therapeutix Announces First Patient Randomized in HELIOS-3 Phase 3 Program for AXPAXLI in NPDR
OCUL
New Projects/Investments
- Ocular Therapeutix has randomized the first patient in the HELIOS-3 Phase 3 registrational program for AXPAXLI (OTX-TKI) for the treatment of non-proliferative diabetic retinopathy (NPDR).
- The HELIOS program, comprising HELIOS-2 and HELIOS-3, aims to evaluate AXPAXLI's ability to alter the course of NPDR with infrequent dosing, potentially as infrequent as every 12 months.
- The studies are designed as superiority trials, targeting a broad diabetic retinopathy label by including patients with non-center-involved diabetic macular edema, and utilize a novel ordinal ≥2-step diabetic retinopathy severity score (DRSS) primary endpoint.
- This program addresses a significant unmet need, as there are over 6 million NPDR patients in the U.S., with fewer than 1% currently receiving therapy due to the burden of frequent injections.
Nov 24, 2025, 12:00 PM
Ocular Therapeutix Provides Update on AXPAXLI Clinical Trials and Commercial Strategy
OCUL
New Projects/Investments
Product Launch
Guidance Update
- Ocular Therapeutix (OCUL) is advancing AXPAXLI, its lead program for retinal diseases, with two pivotal Phase III studies for wet macular degeneration: SOL-1 (superiority study) with card turn in Q1 2026, and SOLAR (non-inferiority study) with card turn in H1 2027.
- The company aims for AXPAXLI to achieve the first and only superiority label versus an anti-VEGF for wet AMD, supported by an IP extension to 2044.
- OCUL plans to leverage a 505(b)(2) regulatory pathway for efficient submission after the successful SOLR study, benefiting from both components of AXPAXLI being independently FDA-approved and a Special Protocol Assessment (SPA).
- For diabetic retinopathy and diabetic macular edema, OCUL is conducting pivotal studies (Helios 2 and 3) using a novel ordinal endpoint, with the expectation of securing a broad label covering all diabetic retinal disease.
- OCUL is well-capitalized and possesses the expertise to commercialize AXPAXLI independently, with no current plans for partnerships or licensing opportunities.
Nov 18, 2025, 2:30 PM
Ocular Therapeutix Provides Updates on AXPAXLI Clinical Programs and Commercial Strategy
OCUL
New Projects/Investments
Product Launch
Guidance Update
- Ocular Therapeutix is advancing two pivotal Phase III programs for AXPAXLI: SOL-1, a superiority study with card turn anticipated in Q1 2026, and SOL-R, a non-inferiority study with card turn expected in H1 2027.
- AXPAXLI, a highly potent and selective TKI on a hydrogel platform, is being developed for wet macular degeneration, diabetic retinopathy, and diabetic macular edema, with the goal of offering a once-a-year injection to enhance treatment sustainability and patient outcomes.
- The company anticipates achieving a superiority label for AXPAXLI in wet AMD, which would allow for flexible dosing every six to twelve months, and holds an IP extension until 2044.
- Ocular Therapeutix plans an efficient regulatory submission utilizing a 505(b)(2) pathway and intends to commercialize AXPAXLI independently, highlighting that the diabetic retinopathy market is 3.5 times larger than wet macular degeneration.
Nov 18, 2025, 2:30 PM
Ocular Therapeutix Provides Updates on AXPAXLI Clinical Programs and Commercial Strategy
OCUL
New Projects/Investments
Product Launch
Guidance Update
- Ocular Therapeutix is advancing two Phase III programs for AXPAXLI in wet macular degeneration (wet AMD): SOL-1 (superiority study) with card turn anticipated in Q1 2026, and SOL-R (non-inferiority study) with card turn expected in H1 2027.
- AXPAXLI, a potent and selective TKI on a hydrogel platform, is being developed for wet AMD, diabetic retinopathy (DR), and diabetic macular edema (DME). The company anticipates a superiority label for wet AMD, allowing for dosing every six to twelve months, and has an IP extension to 2044.
- The target market for diabetic retinopathy is 3.5 times larger than wet AMD, with less than 1% of patients currently treated due to sustainability issues. AXPAXLI aims to offer a once-a-year injection for DR, with pivotal studies (Helios 2 and 3) utilizing an FDA-validated ordinal endpoint for a broad label covering all diabetic retinal disease.
- The regulatory submission process is expected to be efficient via a 505(b)(2) pathway, as AXPAXLI's components are already FDA-approved, and SOL-1 has a Special Protocol Assessment (SPA). Ocular Therapeutix plans to commercialize AXPAXLI independently, leveraging its existing Dextenza commercial team.
Nov 18, 2025, 2:30 PM
Oculis Reports Q3 2025 Financial Results and Provides Pipeline Update
OCUL
Earnings
Guidance Update
New Projects/Investments
- Oculis reported $182.2 million in cash, cash equivalents, and short-term investments as of September 30, 2025, with a recent $110 million financing extending its cash runway into 2029.
- The company is accelerating its portfolio development, with Privosegtor moving into the PIONEER pivotal program for Acute Optic Neuritis (AON) and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION), with the first trial, PIONEER-1, expected to initiate in Q4 2025.
- OCS-01 DIAMOND Phase 3 trials for diabetic macular edema (DME) are on track for topline results in Q2 2026, and the Licaminlimab PREDICT-1 registrational trial for dry eye disease (DED) is expected to start in Q4 2025.
- For the three months ended September 30, 2025, research and development expenses were $17.6 million, and general and administrative expenses were $8.0 million. The year-to-date net loss for the nine months ended September 30, 2025, was $89.7 million.
Nov 10, 2025, 9:05 PM
Ocular Therapeutix Provides Q3 2025 Business and Financial Update
OCUL
Earnings
Guidance Update
New Projects/Investments
- Ocular Therapeutix ended Q3 2025 with approximately $345 million in cash, which does not reflect $445 million in net proceeds from an October equity financing, providing an expected cash runway into 2028.
- The SOLAR registrational study for XPAXLY in Wet AMD has reached its target randomization of 555 subjects, with top-line data anticipated in the first half of 2027.
- The SOL1 superiority trial for XPAXLY in Wet AMD remains on track for top-line data in the first quarter of 2026, demonstrating over 95% patient retention.
- The Helios program for diabetic retinopathy, including nonproliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME), is set to initiate imminently, with Helios 2 and Helios 3 designed as superiority trials under FDA agreements.
Nov 4, 2025, 1:00 PM
Quarterly earnings call transcripts for OCULAR THERAPEUTIX.
Ask Fintool AI Agent
Get instant answers from SEC filings, earnings calls & more