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OCULAR THERAPEUTIX (OCUL)

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Earnings summaries and quarterly performance for OCULAR THERAPEUTIX.

Research analysts who have asked questions during OCULAR THERAPEUTIX earnings calls.

Sean McCutcheon

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 +22 more
TB

Tara Bancroft

TD Cowen

5 questions for OCUL

Also covers: ADVM, CELC, DAWN +11 more
YC

Yi Chen

H.C. Wainwright & Co.

5 questions for OCUL

Also covers: ANGO, APDN, BLFS +22 more
Biren Amin

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 +6 more
DS

Dingding Shi

Jefferies

2 questions for OCUL

Also covers: ADCT, ASND, AUTL +6 more
Gregory Harrison

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, CRNX +4 more
BM

Bill Maughan

Clear Street

1 question for OCUL

Also covers: DCTH, RGNX
C

Catherine

Citizens

1 question for OCUL

Also covers: BCRX, KALV
CO

Catherine Okoukoni

Citizens JMP Securities, LLC

1 question for OCUL

Also covers: ALT
Catherine Okoukoni

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

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 +6 more
Kelly Shi

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 +3 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 Announces Positive Phase 3 SOL-1 Results for AXPAXLI
OCUL
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
  • Ocular Therapeutix announced positive top-line results from the Phase 3 SOL-1 trial for AXPAXLI in wet AMD, demonstrating superiority over aflibercept. This makes AXPAXLI the first and only investigational product in wet AMD with a novel mechanism of action to successfully achieve this milestone against an approved anti-VEGF agent.
  • At the week 36 primary endpoint, 74.1% of AXPAXLI subjects maintained vision, compared to 55.8% in the aflibercept arm, with a statistically significant risk difference of 17.5% (p-value 0.0006).
  • AXPAXLI also demonstrated sustained durability and anatomic control, with 65.9% of subjects maintaining vision and 44.1% maintaining central subfield thickness within 30 microns of baseline through week 52. The drug was generally well-tolerated, with no observed treatment-related ocular or systemic serious adverse events.
  • The company plans to pursue FDA approval via the accelerated 505(b)(2) pathway, aiming for a superiority label that could bypass payer step edits and potentially redefine wet AMD treatment.
Feb 17, 2026, 1:00 PM
Ocular Therapeutix Announces Positive Top-Line Results for AXPAXLI in Wet AMD SOL-1 Trial
OCUL
New Projects/Investments
Product Launch
  • Ocular Therapeutix announced positive top-line results from the SOL-1 Phase 3 trial for AXPAXLI in wet AMD, demonstrating superiority to aflibercept 2 mg.
  • AXPAXLI showed superiority in maintaining vision, with 74.1% of subjects maintaining vision at week 36 (vs. 55.8% for aflibercept, p=0.0006) and 65.9% at week 52.
  • The trial also demonstrated sustained anatomic control, with 55.9% of AXPAXLI subjects maintaining central subfield thickness within 30 microns of baseline through week 36 and 44.1% through week 52.
  • AXPAXLI was generally well-tolerated, with no observed treatment-related ocular or systemic serious adverse events.
  • Ocular Therapeutix plans to pursue regulatory approval via the accelerated 505(b)(2) pathway for AXPAXLI.
Feb 17, 2026, 1:00 PM
Ocular Therapeutix Announces Positive Top-Line Results for AXPAXLI in Wet AMD SOL-1 Trial
OCUL
Product Launch
New Projects/Investments
  • Ocular Therapeutix announced positive top-line results from the SOL-1 Phase 3 registrational trial for AXPAXLI in wet AMD.
  • AXPAXLI demonstrated superiority to an approved anti-VEGF agent (aflibercept 2 mg), a significant achievement as no other novel mechanism of action product has done so in over two decades.
  • The trial met its primary endpoint, with 74.1% of AXPAXLI subjects maintaining vision through week 36, compared to 55.8% for aflibercept, showing high statistical significance (p-value of 0.0006).
  • AXPAXLI exhibited sustained efficacy and a well-tolerated safety profile, with 65.9% of subjects maintaining vision and 44.1% maintaining central subfield thickness within 30 microns of baseline at week 52, and no observed treatment-related ocular or systemic serious adverse events.
  • The company plans to pursue regulatory submission through the accelerated 505(b)(2) pathway based on the SOL-1 data.
Feb 17, 2026, 1:00 PM
Ocular Therapeutix Announces Positive Topline Results from SOL-1 Phase 3 Superiority Trial for AXPAXLI
OCUL
New Projects/Investments
  • Ocular Therapeutix, Inc. announced positive topline results from the SOL-1 Phase 3 superiority trial of AXPAXLI (OTX-TKI) for the treatment of wet age-related macular degeneration (AMD).
  • The trial met its superiority primary endpoint at Week 36, with 74.1% of subjects in the AXPAXLI arm maintaining vision, a 17.5% risk difference (p=0.0006) compared to the aflibercept (2 mg) arm.
  • At Week 52, 65.9% of AXPAXLI subjects maintained vision, representing a 21.1% risk difference (p <0.0001) compared to the aflibercept (2 mg) arm.
  • AXPAXLI was generally well-tolerated in SOL-1, with no treatment-related ocular serious adverse events (SAEs) observed.
  • Ocular Therapeutix plans to submit a New Drug Application (NDA) based on the SOL-1 data, subject to planned formal discussions with the U.S. FDA.
Feb 17, 2026, 12:00 PM
Ocular Therapeutix to Announce SOL-1 Phase 3 Trial Results
OCUL
New Projects/Investments
  • Ocular Therapeutix, Inc. will host a webcast on Tuesday, February 17, 2026, to review the topline results of the SOL-1 Phase 3 superiority clinical trial for AXPAXLI™ (OTX-TKI).
  • AXPAXLI™ is an investigational product candidate for the treatment of wet age-related macular degeneration (wet AMD).
  • Detailed data from the trial will be presented at the 49th Macula Society Annual Meeting between February 25 \u2013 28, 2026.
  • AXPAXLI™ utilizes the company's ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology.
Feb 13, 2026, 10:00 PM
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.
Feb 5, 2026, 12:13 PM
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).
Feb 5, 2026, 12:00 PM
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