This section highlights FDA-related milestones and regulatory updates for drugs developed by Ocular Therapeutix (OCUL).
Over the past two years, Ocular Therapeutix has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AXPAXLI, OTX-TKI, and DEXTENZA. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
AXPAXLI FDA Regulatory Timeline and Events
AXPAXLI is a drug developed by Ocular Therapeutix for the following indication: In Diabetic Retinopathy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AXPAXLI
- Announced Date:
- April 13, 2026
- Indication:
- In Diabetic Retinopathy
Announcement
Ocular Therapeutix, Inc announced additional positive Week 52 data from the SOL-1 Phase 3 superiority trial of AXPAXLI (also known as OTX-TKI), its investigational product candidate for the treatment of wet age-related macular degeneration (wet AMD).
AI Summary
Ocular Therapeutix reported additional positive Week 52 results from the SOL-1 Phase 3 superiority trial of AXPAXLI (OTX-TKI) for wet AMD. The trial met its primary endpoint: 74.1% of AXPAXLI subjects maintained vision at Week 36 (17.5% advantage) and 65.9% maintained vision at Week 52 (21.1% advantage) versus aflibercept.
Post-hoc analyses showed strong durability and anatomical control. Median time to central subfield thickness (CSFT) worsening was long—39 weeks to a ≥30 µm increase and 46 weeks to a ≥75 µm increase from Week 8. Visual acuity gains achieved during the loading phase were generally maintained through Week 52 across baseline vision subgroups. For subjects who experienced vitreous floater adverse events, visible drug particles resolved on average by about 20 weeks.
AXPAXLI is an investigational bioresorbable intravitreal hydrogel that delivers axitinib, a multi-target tyrosine kinase inhibitor with anti‑angiogenic effects for wet AMD.Read Announcement
- Drug:
- AXPAXLI
- Announced Date:
- February 5, 2026
- Indication:
- In Diabetic Retinopathy
Announcement
Ocular Therapeutix, Inc provided recent business highlights and reported financial results for the fourth quarter and year ended December 31, 2025.
AI Summary
Ocular Therapeutix reported pipeline and financial highlights for the fourth quarter and year ended December 31, 2025. The SOL-1 Phase 3 superiority trial remains masked; its data are expected to be presented at the 49th Macula Society Annual Meeting. The company plans to seek approval for AXPAXLI in wet AMD based on SOL-1 52-week data if results are positive and after planned regulatory interactions. In December 2025, Ocular completed randomization of 631 subjects in the SOL-R Phase 3 non-inferiority trial and has accelerated topline results to be anticipated in 1Q 2027. The HELIOS-3 Phase 3 trial in diabetic retinopathy is underway.
Ocular ended December 31, 2025 with $737.1 million in cash, which the company says provides runway into 2028. For the year, it reported a net loss of $265.9 million, or $1.42 per share, versus a $193.5 million loss, or $1.22 per share, in 2024. Outstanding shares were about 217.7 million as of February 2, 2026.
The company is observing a quiet period and did not hold a fourth-quarter 2025 call; quarterly calls will resume with first-quarter 2026 results.
Read Announcement- Drug:
- AXPAXLI
- Announced Date:
- November 24, 2025
- Indication:
- In Diabetic Retinopathy
Announcement
Ocular Therapeutix, Inc. announced that the first patient has been randomized in the HELIOS-3 Phase 3 registrational program for AXPAXLI (also known as OTX-TKI) for the treatment of non-proliferative diabetic retinopathy (NPDR).
AI Summary
Ocular Therapeutix announced that the first patient has been randomized in HELIOS-3, the second Phase 3 registrational trial of AXPAXLI (OTX-TKI) for non-proliferative diabetic retinopathy (NPDR). This step advances a program meant to test whether AXPAXLI can slow or improve disease with fewer injections.
HELIOS-2 and HELIOS-3 are complementary superiority trials that use a novel ordinal diabetic retinopathy severity score (DRSS) primary endpoint, which captures improvement, stability, or worsening across the full disease spectrum. The program also includes patients with non-center-involved diabetic macular edema (non-CI-DME) to target a broader diabetic retinopathy label.
HELIOS-3 will enroll about 930 subjects in three arms: AXPAXLI with re-dose at week 24, AXPAXLI with sham at week 24, and sham/sham. Subjects are assessed every 12 weeks and the primary endpoint is the DRSS change at Week 52.
Ocular and investigators say AXPAXLI’s potential for durable efficacy and lower treatment burden could help many patients who currently avoid frequent injections.
Read Announcement- Drug:
- AXPAXLI
- Announced Date:
- September 30, 2025
- Indication:
- In Diabetic Retinopathy
Announcement
Ocular Therapeutix, Inc. announce plans for a registrational program in non-proliferative diabetic retinopathy (NPDR), and share further details on how AXPAXLI™ (also known as OTX-TKI) is being positioned to redefine retina treatment.
AI Summary
Ocular Therapeutix held an Investor Day to announce a new Phase 3 program for non-proliferative diabetic retinopathy (NPDR). The company plans two registrational trials, HELIOS-2 and HELIOS-3, to test AXPAXLI™ (OTX-TKI), its long-acting eye implant, in NPDR patients without center-involved diabetic macular edema.
HELIOS-2 is a two-arm superiority study comparing a single AXPAXLI injection to ranibizumab over 52 weeks. It uses a novel, ordinal diabetic retinopathy severity score (DRSS) endpoint agreed with the FDA under a Special Protocol Assessment.
HELIOS-3 is a three-arm superiority trial that evaluates two AXPAXLI dosing schedules against sham injections, also with a 52-week ordinal DRSS endpoint. This design lets every participant’s change in disease severity count toward the results.
AXPAXLI is designed to redefine retina care by offering durable, anti-VEGF treatment with fewer injections. If successful, it could reduce patient burden, expand treatment access, and reshape how ophthalmologists manage retinal vascular diseases.
Read Announcement- Drug:
- AXPAXLI
- Announced Date:
- August 12, 2025
- Indication:
- In Diabetic Retinopathy
Announcement
Ocular Therapeutix, Inc. announced it has received written agreement regarding a registrational trial design from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the Company's planned clinical trial of AXPAXLI (also known as OTX-TKI) for the treatment of non-proliferative diabetic retinopathy (NPDR).
AI Summary
Ocular Therapeutix, Inc. announced it has received written agreement from the U.S. Food and Drug Administration under a Special Protocol Assessment (SPA) for its planned Phase 3 trial of AXPAXLI (OTX-TKI) in non-proliferative diabetic retinopathy (NPDR). This SPA confirms that the trial’s design, endpoints and analysis plan meet FDA requirements for a registrational study.
Pravin U. Dugel, MD, CEO of Ocular Therapeutix, called the SPA a major milestone. He noted that NPDR affects about 9 million people in the U.S. and said AXPAXLI’s potential for once-a-year dosing could reduce vision-threatening complications and reshape diabetes eye care.
The new trial will test whether a single intravitreal injection of AXPAXLI can prevent disease progression and improve retinal health over 48 weeks. The SPA gives the company a clear regulatory pathway to seek approval if results meet agreed criteria.
Ocular Therapeutix plans to share more details on its NPDR strategy at its Investor Day on September 30, 2025.
Read Announcement- Drug:
- AXPAXLI
- Announced Date:
- May 28, 2025
- Indication:
- In Diabetic Retinopathy
Announcement
Ocular Therapeutix, Inc. announced that enrollment in the SOL-R registrational trial of its product candidate AXPAXLI™ in wet age-related macular degeneration (wet AMD) will close this week.
AI Summary
Ocular Therapeutix, Inc. recently announced that enrollment in its SOL-R registrational trial for AXPAXLI™, a product candidate for wet age-related macular degeneration (wet AMD), will close this week. This trial is the largest retinal tyrosine kinase inhibitor (TKI) study to date and aims to randomly assign at least 555 subjects. Patients are being enrolled from around 100 sites in countries including the U.S., Argentina, India, and Australia.
The company highlighted the rapid pace of trial enrollment, which reflects their commitment to delivering innovative treatments for wet AMD. With enrollment now complete, the focus shifts to disciplined trial execution and maintaining high patient retention. The SOL-R study, in combination with a complementary trial (SOL-1), will provide the robust clinical data needed to support a future New Drug Application (NDA) with the FDA for AXPAXLI.
Read Announcement- Drug:
- AXPAXLI
- Announced Date:
- January 14, 2025
- Target Action Date:
- Q4 2025
- Estimated Target Date Range:
- October 1, 2025 - December 31, 2025
- Indication:
- In Diabetic Retinopathy
Announcement
Ocular Therapeutix, Inc. announced that topline data anticipated in Q4 2025
AI Summary
Ocular Therapeutix announced that topline data from its Phase 3 SOL-1 trial in wet age-related macular degeneration (wet AMD) is now expected in Q4 2025. The SOL-1 study, which compared a single injection of AXPAXLI to a single dose of aflibercept, completed randomization in December 2024. With more than 300 patients enrolled across over 100 sites in the United States and Argentina, the study is designed to evaluate the durability and efficacy of AXPAXLI as a potential alternative treatment for wet AMD. In addition to this trial, Ocular plans to seek FDA feedback in the first half of 2025 regarding the clinical trial design for AXPAXLI in non-proliferative diabetic retinopathy. These advancements underline the company’s commitment to addressing unmet needs in vision care by developing treatments that may decrease treatment burden and improve patient outcomes.
Read Announcement- Drug:
- AXPAXLI
- Announced Date:
- January 14, 2025
- Target Action Date:
- H1 2025
- Estimated Target Date Range:
- January 1, 2025 - June 30, 2025
- Indication:
- In Diabetic Retinopathy
Announcement
Ocular Therapeutix, Inc. announced that Company plans to seek FDA feedback in H1 2025 on clinical trial design for AXPAXLI in NPDR
AI Summary
Ocular Therapeutix announced plans to seek FDA feedback in the first half of 2025 regarding the clinical trial design for AXPAXLI in patients with non-proliferative diabetic retinopathy (NPDR). The company aims to extend the promising benefits of AXPAXLI beyond its current focus on wet AMD. Early studies, including the HELIOS trial, demonstrated that a single injection of AXPAXLI could reduce the risk of vision loss, with treated patients showing no vision-threatening complications at 48 weeks. This upcoming FDA engagement is a key step for Ocular as it works to expand its clinical program and address a major unmet need in diabetic retinopathy treatment. By seeking regulatory input, Ocular Therapeutix hopes to refine its trial design and further develop AXPAXLI’s potential to provide a longer-lasting and sustainable treatment option for patients at risk of vision loss.
Read Announcement- Drug:
- AXPAXLI
- Announced Date:
- January 14, 2025
- Indication:
- In Diabetic Retinopathy
Announcement
Ocular Therapeutix, Inc. plans to advance AXPAXLI in non-proliferative diabetic retinopathy (NPDR), and the Company's strategic outlook for 2025 in its presentation at the 43rd Annual J.P. Morgan Healthcare Conference (JPM 2025).
AI Summary
Ocular Therapeutix, Inc. shared exciting news at the 43rd Annual J.P. Morgan Healthcare Conference regarding its plans for AXPAXLI™. After making strong progress in wet age-related macular degeneration (AMD) with encouraging patient enrollment in its SOL-R trial, the company is now looking to expand its focus. In 2025, Ocular plans to target non-proliferative diabetic retinopathy (NPDR), a major cause of vision loss in the working population. Based on positive Phase 1 HELIOS trial results—where a single AXPAXLI injection showed promising benefits including preventing vision-threatening complications—the company intends to seek FDA feedback in the first half of 2025 on the clinical trial design for NPDR. This strategic move underlines Ocular’s commitment to addressing two global retinal diseases while aiming to reduce treatment burden and improve patient outcomes.
Read Announcement- Drug:
- AXPAXLI
- Announced Date:
- December 2, 2024
- Target Action Date:
- Q4 2025
- Estimated Target Date Range:
- October 1, 2025 - December 31, 2025
- Indication:
- In Diabetic Retinopathy
Announcement
Ocular Therapeutix, Inc announced that Topline clinical data from SOL-1 expected in Q4 2025.
AI Summary
Ocular Therapeutix, Inc. announced an important milestone with its registrational SOL-1 Phase 3 trial evaluating AXPAXLI for the treatment of wet age-related macular degeneration (wet AMD). With over 300 patients enrolled and randomization coming to an end, the trial is set to provide clear insights into the safety and effectiveness of AXPAXLI, a candidate designed to offer a durable treatment option that may require dosing only every six to nine months.
Topline clinical data from SOL-1 is expected to be reported in the fourth quarter of 2025. This data will be crucial in determining the potential benefits of AXPAXLI for patients with wet AMD. The progress in SOL-1 also supports and accelerates enrollment in the SOL-R trial, reinforcing the company’s commitment to improving vision outcomes for patients facing this challenging condition.
Read Announcement- Drug:
- AXPAXLI
- Announced Date:
- December 2, 2024
- Indication:
- In Diabetic Retinopathy
Announcement
Ocular Therapeutix, Inc. announced that more than 300 patients have been randomized in the SOL-1 Phase 3 trial for AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI), and the trial is expected to close randomization this week.
AI Summary
Ocular Therapeutix, Inc. announced that over 300 patients have been randomized in the SOL-1 Phase 3 trial for AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI) to treat wet age-related macular degeneration (wet AMD). This milestone indicates that the trial will complete its randomization phase within the week, marking an important step in the clinical evaluation of this innovative therapy.
The SOL-1 trial, which is the first registrational study for AXPAXLI in wet AMD, seeks to assess the safety and effectiveness of a treatment that could be administered every six to nine months. This progress is a promising development for patients, as it addresses the need for durable therapies that improve long-term vision outcomes.
Read Announcement- Drug:
- AXPAXLI
- Announced Date:
- August 7, 2024
- Indication:
- In Diabetic Retinopathy
Announcement
Ocular Therapeutix, Inc. announced that the Company has received a written response from the U.S. Food and Drug Administration (FDA) that the Phase 3 SOL-R clinical trial is appropriate for use as the Company's second adequate and well controlled study of AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI) for the treatment of patients with wet age-related macular degeneration (wet AMD).
AI Summary
Ocular Therapeutix, Inc. announced that the FDA has provided written feedback confirming that its Phase 3 SOL-R clinical trial qualifies as the second adequate and well-controlled study for AXPAXLI™ (axitinib intravitreal implant) in patients with wet age-related macular degeneration (wet AMD). This Type C written response indicates the trial is acceptable as a registrational study to support a potential New Drug Application and product label for AXPAXLI™. The FDA also noted that combining one superiority study with one non-inferiority study is generally acceptable for marketing approval in wet AMD.
Along with the ongoing SOL-1 trial, SOL-R will form the basis of Ocular Therapeutix’s Phase 3 program. This clear regulatory path provides important support for advancing AXPAXLI™ as a new treatment option for patients suffering from wet AMD.
Read Announcement- Drug:
- AXPAXLI
- Announced Date:
- July 30, 2024
- Indication:
- In Diabetic Retinopathy
Announcement
Ocular Therapeutix, Inc. nnounced that the first patients have been enrolled in the Phase 3 SOL-R clinical trial evaluating repeat dosing of AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI) for the treatment of patients with wet age-related macular degeneration (wet AMD).
AI Summary
Ocular Therapeutix, Inc. announced that the first patients have been enrolled in the Phase 3 SOL-R clinical trial to evaluate the repeat dosing of AXPAXLI™ (axitinib intravitreal implant) for treating wet age-related macular degeneration (wet AMD). The global study will compare a six-month repeat dosing regimen of AXPAXLI with aflibercept given every eight weeks. Approximately 825 patients with wet AMD, including treatment-naïve individuals or those diagnosed within three months, will be enrolled in this trial. The study is designed as a non-inferiority trial to determine if repeat dosing of AXPAXLI can safely and effectively maintain visual acuity compared to the current standard therapy. This research aims to provide practical evidence for a more convenient dosing schedule that aligns with real-world treatment needs, potentially reducing the treatment burden for patients with wet AMD.
Read Announcement- Drug:
- AXPAXLI
- Announced Date:
- July 10, 2024
- Indication:
- In Diabetic Retinopathy
Announcement
Ocular Therapeutix, Inc. announced that a late-breaking abstract related to the Phase 1 HELIOS study of AXPAXLI (axitinib intravitreal implant) for non-proliferative diabetic retinopathy (NPDR) was accepted for presentation at the 42nd American Society of Retina Specialists (ASRS) Annual Scientific Meeting being held July 17-20 in Stockholm, Sweden.
AI Summary
Ocular Therapeutix, Inc. recently announced that a late-breaking abstract from its Phase 1 HELIOS study has been accepted for presentation at the 42nd American Society of Retina Specialists (ASRS) Annual Scientific Meeting in Stockholm, Sweden, scheduled for July 17–20. The study evaluates AXPAXLI, a sustained-release axitinib intravitreal implant designed to treat non-proliferative diabetic retinopathy (NPDR).
The abstract, titled “Interim Safety and Efficacy Results From the Phase 1 HELIOS Trial of Sustained-release Axitinib Implant (OTX-TKI) for NPDR,” will be presented by Dr. Dilsher S. Dhoot on July 18 at 10:47 AM CEST during the Diabetic Retinopathy Symposium 2 session. The Phase 1 HELIOS trial is a multi-center, double-masked, randomized study in the U.S. that is assessing the implant’s safety, tolerability, and potential efficacy in patients with moderately severe to severe NPDR without center-involved diabetic macular edema.
Read Announcement- Drug:
- AXPAXLI
- Announced Date:
- June 13, 2024
- Indication:
- In Diabetic Retinopathy
Announcement
Ocular Therapeutix, Inc. today hosted an Investor Day where it highlighted excellent clinical development progress with AXPAXLI for wet age-related macular degeneration (wet AMD) and non-proliferative diabetic retinopathy (NPDR) and updated its corporate strategy.
AI Summary
Ocular Therapeutix, Inc. hosted an Investor Day where the company showcased its robust progress in clinical development for AXPAXLI. The presentation highlighted encouraging data for wet age-related macular degeneration (wet AMD) from the pivotal SOL-1 trial, which has already enrolled 151 subjects across 60 sites. Additionally, the company announced plans for the SOL-R study, a repeat dosing trial designed to further evaluate AXPAXLI in wet AMD. This phase is seen as a key step in reinforcing the drug's monotherapy activity, potential durability, and favorable safety profile.
The Investor Day also featured positive topline data from the 48-week HELIOS study in patients with non-proliferative diabetic retinopathy (NPDR). Alongside these clinical advancements, the company updated its corporate strategy to become a leader in retinal care, emphasizing a focused approach to retinal vascular disease markets.
Read Announcement
OTX-TKI FDA Regulatory Timeline and Events
OTX-TKI is a drug developed by Ocular Therapeutix for the following indication: For the treatment of wet AMD.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- OTX-TKI
- Announced Date:
- February 23, 2026
- Indication:
- For the treatment of wet AMD
Announcement
Ocular Therapeutix, Inc. announced that the Company will present detailed results from the SOL-1 Phase 3 superiority clinical trial of AXPAXLI™ (also known as OTX-TKI), for the treatment of wet age-related macular degeneration (wet AMD), at the 49th Macula Society Annual Meeting on Friday, February 27, 2026, with data presentations starting at 1:00 PM PT (4:00 PM ET). Ocular plans to host an investor webcast on Monday, March 2, 2026, at 7:30 AM ET to discuss the Macula Society presentations.
AI Summary
Ocular Therapeutix will present detailed results from the SOL-1 Phase 3 superiority trial of AXPAXLI (OTX‑TKI) for wet age‑related macular degeneration at the 49th Macula Society Annual Meeting in San Diego. The company’s symposium runs Friday, February 27, 2026, from 12:45–2:15 PM PT, with SOL‑1 data presentations beginning at 1:00 PM PT (4:00 PM ET). Ocular will furnish the symposium slides to the SEC via a Current Report on Form 8‑K at 4:00 PM ET on February 27 and will post all slides on its website.
Ocular will host an investor webcast on Monday, March 2, 2026, at 7:30 AM ET to review the SOL‑1 results. The webcast will include brief prepared remarks followed by a live Q&A with Ocular leadership and retina key opinion leaders. The live and archived webcast and presentation slides will be available on the Events and Presentations section of the company’s Investor Relations page; a replay will be archived for at least 30 days.
Read Announcement- Drug:
- OTX-TKI
- Announced Date:
- February 17, 2026
- Indication:
- For the treatment of wet AMD
Announcement
Ocular Therapeutix, Inc. announced positive topline results from the SOL-1 Phase 3 superiority trial of AXPAXLI (also known as OTX-TKI), its investigational product candidate, for the treatment of wet age-related macular degeneration (AMD).
AI Summary
Ocular Therapeutix announced positive topline results from the SOL-1 Phase 3 superiority trial of AXPAXLI (OTX-TKI) for wet age-related macular degeneration. The trial met its primary endpoint: 74.1% of AXPAXLI subjects maintained vision at Week 36, a 17.5% absolute advantage (p=0.0006) versus aflibercept. At Week 52, 65.9% maintained vision versus 44.2% with aflibercept (21.1% difference, p<0.0001).
AXPAXLI also showed higher rescue-free rates (80.6%, 74.7%, 68.8% at Weeks 24, 36, 52) than aflibercept (72.1%, 56.4%, 47.7%), and stronger fluid control: 55.9% of AXPAXLI subjects kept central subfield thickness within 30 μm at Week 36, a 17.1% benefit (nominal p=0.0013). An exploratory analysis using SOL-R criteria showed a 77.1% rescue-free rate at Week 24.
AXPAXLI was generally well tolerated with no treatment-related ocular or systemic serious adverse events reported in SOL-1 and no cases of endophthalmitis, retinal vasculitis, retinal detachment, or implant migration. Subjects remain under follow-up and detailed results will be presented publicly.
Read Announcement- Drug:
- OTX-TKI
- Announced Date:
- February 13, 2026
- Indication:
- For the treatment of wet AMD
Announcement
Ocular Therapeutix, Inc. announced that the Company will host a webcast to review the topline results of the SOL-1 Phase 3 superiority clinical trial of AXPAXLI™ (also known as OTX-TKI), for the treatment of wet age-related macular degeneration (wet AMD), on Tuesday, February 17, 2026.
AI Summary
Ocular Therapeutix announced it will host a webcast on Tuesday, February 17, 2026 at 8:00 AM ET to review topline results from the SOL-1 Phase 3 superiority clinical trial of AXPAXLI (also known as OTX‑TKI) for the treatment of wet age‑related macular degeneration (wet AMD). The webcast will cover the main trial outcomes and what they may mean for the program’s next steps.
Interested parties can register for the virtual webcast, which will be available live and later as an archived replay on the Ocular Therapeutix website in the Events and Presentations section of Investor Relations; the replay will remain available for at least 30 days. More detailed SOL-1 data will be presented at the 49th Macula Society Annual Meeting. The company also recommends following its website, LinkedIn, or X for updates.
Read Announcement- Drug:
- OTX-TKI
- Announced Date:
- December 8, 2025
- Indication:
- For the treatment of wet AMD
Announcement
Ocular Therapeutix, Inc. announced that following recent public statements from U.S. Food and Drug Administration (FDA) leadership and other recent interactions with the FDA's Division of Ophthalmology, the Company now intends to submit a New Drug Application (NDA) for AXPAXLI™ (also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD) following year one data, if positive, from its ongoing SOL-1 Phase 3 clinical trial for which data are on track for the first quarter of 2026.
AI Summary
Ocular Therapeutix said it now plans to submit a New Drug Application (NDA) for AXPAXLI (OTX-TKI) for wet age-related macular degeneration shortly after positive year-one results from its ongoing SOL-1 Phase 3 trial, with topline data on track for the first quarter of 2026. The company will move forward only if the year-one data are positive.
Ocular intends to use the 505(b)(2) regulatory pathway to potentially shorten the review timeline. SOL-1 is a superiority trial comparing a single dose of AXPAXLI to a single injection of aflibercept (2 mg) with the same dosing cadence, a design meant to power a strong efficacy claim and support a registrational filing based on one pivotal study.
If approved, AXPAXLI could become the first tyrosine kinase inhibitor commercialized for wet AMD, offering extended durability (potentially 6–12 months) and a simple intravitreal injection procedure that may improve adherence and long-term outcomes. Year-two data will further inform clinicians and payors.Read Announcement
- Drug:
- OTX-TKI
- Announced Date:
- February 3, 2025
- Target Action Date:
- February 8, 2025
- Indication:
- For the treatment of wet AMD
Announcement
Ocular Therapeutix, Inc. announced upcoming presentations at the Angiogenesis, Exudation, and Degeneration 2025 virtual meeting on February 8, 2025.
AI Summary
Ocular Therapeutix, Inc. has announced its upcoming presentations at the Angiogenesis, Exudation, and Degeneration 2025 virtual meeting on February 8, 2025. The company will present detailed findings on its investigational product, OTX-TKI, now in Phase 1 through Phase 3 trials. One presentation, titled "OTX-TKI From Phase 1 to Phase 3: SOL-1 and SOL-R Trials for Neovascular AMD," will be given by Dr. Carl J. Danzig at 2:30 PM ET, focusing on emerging imaging techniques and therapies for exudative age-related macular degeneration. Additionally, two other sessions will cover key insights on diabetic retinopathy. Dr. Mark R. Barakat will present Phase 1 results from the intravitreal axitinib implant for non-proliferative diabetic retinopathy at 5:20 PM ET, and Dr. Justis P. Ehlers will discuss volumetric macular fluid analysis from the HELIOS clinical trial at 5:25 PM ET.
Read Announcement
DEXTENZA FDA Regulatory Events
DEXTENZA is a drug developed by Ocular Therapeutix for the following indication: Ocular Inflammation and Pain Following Ophthalmic Surgery.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DEXTENZA
- Announced Date:
- October 9, 2024
- Indication:
- Ocular Inflammation and Pain Following Ophthalmic Surgery
Announcement
Ocular Therapeutix, Inc. announced participation in multiple panels and presentations across three ophthalmology meetings in Chicago, Illinois during October 2024.
AI Summary
Ocular Therapeutix, Inc. announced its active role in several key ophthalmology meetings scheduled for October 2024 in Chicago, Illinois. The company will participate in multiple panels and presentations, highlighting its focus on innovative therapies for retinal diseases and eye conditions. At the AAO 2024 meeting, Ocular Therapeutix will share insights during the “Eyecelerator” session, featuring discussions on innovation and ongoing progress within the field.
Dr. Pravin U. Dugel, Executive Chair, President and CEO, will be a panelist on multiple occasions, including discussions on the future of retinal therapeutics. Additionally, Dr. Peter K. Kaiser and Dr. David A. Eichenbaum are set to present at various sessions, showcasing the company’s advancements as a retina-focused organization. These events offer a platform for engaging with experts and disseminating important research findings that could shape the future of retinal treatments.
Read Announcement
