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 +21 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 Reports Q4 and Full Year 2025 Financial Results and Clinical Trial Updates
OCUL
Earnings
Guidance Update
New Projects/Investments
- Ocular Therapeutix reported a cash balance of $737.1 million as of December 31, 2025, with an expected cash runway into 2028.
- Total net revenue for the fourth quarter of 2025 was $13.3 million, a 22.4% decrease compared to the same period in 2024, and full year 2025 total net revenue was $52.0 million, an 18.5% decrease from 2024. This reduction was primarily due to a more challenging reimbursement environment for DEXTENZA.
- The company expects to present topline results for the SOL-1 Phase 3 superiority trial of AXPAXLI in wet AMD at the 49th Macula Society Annual Meeting between February 25-28, 2026. Pending positive results, Ocular plans to submit a New Drug Application (NDA) for AXPAXLI based on SOL-1 52 Week data.
- Randomization for the SOL-R Phase 3 non-inferiority trial in wet AMD was completed in December 2025, with topline results now anticipated in Q1 2027.
- Research and development expenses increased to $50.8 million for Q4 2025 and $197.1 million for the full year 2025, reflecting increased clinical expenses for ongoing Phase 3 trials (SOL-1, SOL-R, HELIOS-3).
6 hours ago
Ocular Therapeutix Reports Q4 and Full Year 2025 Financial Results and Provides Clinical Trial Updates
OCUL
Earnings
Guidance Update
New Projects/Investments
- Ocular Therapeutix reported a cash balance of $737.1 million as of December 31, 2025, with an expected runway into 2028.
- Total net revenue for Q4 2025 was $13.3 million, representing a 22.4% decrease compared to Q4 2024, and full year 2025 total net revenue was $52.0 million, an 18.5% decrease from 2024, primarily due to a challenging reimbursement environment for DEXTENZA.
- The company reported a net loss of $(64.7) million, or $(0.29) per share, for Q4 2025, and a full year 2025 net loss of $(265.9) million, or $(1.42) per share.
- Key clinical updates include the expected presentation of Week 52 results for the SOL-1 Phase 3 superiority trial for AXPAXLI in wet AMD between February 25-28, 2026, with plans to submit an NDA based on positive results. Randomization for the SOL-R Phase 3 non-inferiority trial was completed in December 2025, accelerating topline results to 1Q 2027, and the HELIOS-3 Phase 3 trial in diabetic retinopathy is underway.
6 hours ago
Ocular Therapeutix Appoints David W. Robinson as Global Chief Commercial Officer
OCUL
Management Change
Hiring
New Projects/Investments
- Ocular Therapeutix, Inc. has appointed David W. Robinson as its Global Chief Commercial Officer.
- Mr. Robinson is an accomplished global commercial leader, notably serving as the primary architect for the launch of EYLEA® at Regeneron and most recently as Chief Marketing Officer, Global Ophthalmology at Merck.
- This appointment strategically positions the company for the global launch of AXPAXLI™ (OTX-TKI), if approved, for wet age-related macular degeneration (wet AMD) and non-proliferative diabetic retinopathy (NPDR).
Jan 21, 2026, 12:00 PM
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
Quarterly earnings call transcripts for OCULAR THERAPEUTIX.
Ask Fintool AI Agent
Get instant answers from SEC filings, earnings calls & more