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, DEXTENZA, OTX-TIC, and OTX-TKI. 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:
- 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
- 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:
- January 14, 2025
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- H1 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
- Estimated Event Date Range:
- October 1, 2025 - December 31, 2025
- Target Action Date:
- Q4 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:
- 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:
- December 2, 2024
- Estimated Event Date Range:
- October 1, 2025 - December 31, 2025
- Target Action Date:
- Q4 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:
- 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- Drug:
- AXPAXLI
- Announced Date:
- May 6, 2024
- Indication:
- In Diabetic Retinopathy
Announcement
Ocular Therapeutix, Inc. announced that it will participate at two investor conferences in May
AI Summary
Ocular Therapeutix, Inc., a biopharmaceutical company focused on developing innovative therapies for eye diseases, announced its participation in two important investor conferences this May. The company will take part in a fireside chat at the Citizens JMP Life Sciences Conference on May 13, 2024, at 1:00 PM ET in New York, NY. It will also join another fireside chat at the BofA Securities 2024 Health Care Conference on May 15, 2024, at 3:00 PM PT in Las Vegas, NV.
Investors can watch live webcasts of these sessions by visiting the Investors section on the company’s website. This participation highlights Ocular Therapeutix’s commitment to keeping investors informed about its progress and future plans as it works to improve vision and quality of life through new treatments for eye conditions.
Read Announcement- Drug:
- AXPAXLI
- Announced Date:
- April 18, 2024
- Indication:
- In Diabetic Retinopathy
Announcement
Ocular Therapeutix, Inc. announced positive topline results from the Phase 1 HELIOS study evaluating AXPAXLI versus a sham control in patients with moderately severe to severe non-proliferative diabetic retinopathy (‘NPDR', NCT05695417) without diabetic macular edema (DME). Ocular plans to present the study results at an upcoming meeting.
AI Summary
Ocular Therapeutix, Inc. announced positive topline results from its Phase 1 HELIOS study. The study evaluated AXPAXLI against a sham control in patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema. Results showed that 46.2% of patients receiving AXPAXLI experienced a 1- or 2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS) at 40 weeks, while none in the control group achieved similar improvements. Additionally, no patients in the AXPAXLI group had any worsening in their DRSS, compared to 12.5% in the control group.
The treatment was generally well tolerated with no observed inflammation. Ocular plans to present the study results at an upcoming meeting as they look forward to progressing the treatment into Phase 3 trials for NPDR patients.
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
OTX-TIC FDA Regulatory Events
OTX-TIC is a drug developed by Ocular Therapeutix for the following indication: in patients with open-angle glaucoma or ocular hypertension.
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-TIC
- Announced Date:
- April 6, 2024
- Indication:
- in patients with open-angle glaucoma or ocular hypertension
Announcement
Ocular Therapeutix, Inc. announced positive Phase 2 data for PAXTRAVA (travoprost intracameral implant or OTX-TIC) in patients with open-angle glaucoma or ocular hypertension
AI Summary
Ocular Therapeutix, Inc. recently announced positive Phase 2 data for its investigational product, PAXTRAVA (travoprost intracameral implant or OTX-TIC), in patients with open-angle glaucoma or ocular hypertension. The study showed statistically significant and sustained intraocular pressure (IOP) reductions as early as two weeks, with mean IOP decreasing by approximately 24-30% through six months. Notably, 81.3% of treated eyes did not require any additional IOP‐lowering therapy during this period. The implant was generally well tolerated, with most adverse events being mild and no negative impact on the corneal endothelium. Additionally, the implant demonstrated consistent bioresorption, suggesting that repeat dosing may be possible without risks associated with stacking implants. These promising results support further development of PAXTRAVA and provide a hopeful advancement in the treatment approach for glaucoma patients.
Read Announcement
OTX-TKI FDA Regulatory 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 3, 2025
- Estimated Event Date Range:
- February 8, 2025 - February 8, 2025
- Target Action Date:
- February 08, 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
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