Anti–vascular endothelial growth factor (VEGF) therapy is the current standard of care for exudative retinal diseases. However, new treatments including small-molecule tyrosine kinase inhibitors (TKIs) are being investigated to address unmet needs and to expand treatment options. This article summarizes the current data and future directions for investigational TKIs.
Retinal vascular diseases, including neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), have complex pathophysiology, involving pathways regulating angiogenesis, vascular permeability, inflammation, and fibrosis.1,2 VEGF plays a key role in angiogenesis and vascular permeability through binding VEGF receptors 1-3 (VEGFR).3 In eyes with nAMD and DME, VEGF levels are elevated in aqueous and vitreous humors.2 Although VEGF signaling is a key driver, additional pathways contribute to the pathophysiology of these diseases, such as the TIE2 pathway, whose activation leads to vascular stability and reduced permeability, and IL-6/Janus kinase (JAK) pathway, which has been implicated in inflammation in DME and nAMD.2,4-7
The development of anti-VEGF therapies, administered via intravitreal injection, was a turning point for the treatment of retinal vascular diseases; notably, ranibizumab (Lucentis; Genentech) was approved for nAMD in 2006,8 followed by aflibercept 2 mg (Eylea; Regeneron) for nAMD in 2011.9 Bevacizumab (Avastin; Genentech) is also used off label. Although anti-VEGF therapies are highly effective in reducing disease activity and maintaining vision in clinical trials, real-world long-term outcomes do not match the results of trials, due to multiple factors.10,11 Notably, these therapies require regular treatment, sometimes as often as monthly. This puts a large treatment burden on patients, their caregivers, and health care providers, contributing to patient undertreatment.10,11 Indeed, improved durability and reduced treatment burden are important factors retina specialists consider when deciding on treatment for patients. Recent therapies such as high-dose aflibercept 8 mg (Eylea HD; Regeneron),12 faricimab (Vabysmo; Genentech),13 and the port delivery system with ranibizumab (Susvimo; Genentech),14 were developed to extend drug therapeutic levels between administrations and thereby reduce treatment burden.
Anti-VEGF drugs function extracellularly by binding the ligand VEGF-A extracellularly, thereby inhibiting VEGFR-1 and VEGFR-2 and reducing angiogenesis.1,8-9 However, VEGFR-3 and other pathways contributing to the disease remain active, which may also lead to reduced outcomes over time.1 To address this, new or additional mechanisms of action (MOA) are being evaluated. For example, in addition to VEGF-A, faricimab inhibits angiopoietin-2 (Ang2), a partial agonist of TIE2, which may help to ensure TIE2 activity and subsequent vascular stability by allowing angiopoietin-1 to bind to TIE2 more effectively. Notably, several TKIs that offer a novel MOA compared with current therapies are currently under investigation for retinal diseases. When coupled with sustained-released drug delivery methods, these investigational drugs may address the unmet need of extended durability and treatment burden with a new MOA for treatment of these chronic conditions.
Future Options and Impact
More than 50 TKIs are currently approved by the FDA across therapeutic areas, primarily in oncology; however, none are approved in ophthalmology.15 Currently, 3 TKI molecules across 5 investigational products are under investigation for ophthalmologic indications: vorolanib, axitinib, and migaldendranib (Table 1).
Unlike current anti-VEGF therapies, vorolanib, axitinib, and migaldendranib function intracellularly to inhibit all 3 VEGFRs by binding directly to the VEGFRs rather than the ligands.1,16 In addition to VEGFRs, vorolanib and axitinib inhibit other receptors associated with angiogenesis, including fibroblast growth factor receptors (FGFR)1-3 and platelet-derived growth factor receptor (PDGFR).1 Vorolanib also binds to and inhibits JAK-1, resulting in blockade of IL-6–mediated inflammatory signaling.17 Further, axitinib was found to inhibit TIE2 at clinically relevant concentrations through in vitro HotSpot and IC50 assays, while vorolanib did not display this activity.1 Because TIE2 is associated with vessel stability and vascular health, its inhibition by axitinib may be an undesirable off-target effect that could lead to further vessel leakage. Oral administration of TKIs for nAMD was investigated but was generally not well tolerated; clinical trials were discontinued due in part to gastrointestinal and hepatobiliary adverse events.18 Therefore, efforts have focused on finding ocular delivery methods with sustained or continuous drug release for TKI treatment of retinal disease.
Duravyu (EyePoint Pharmaceuticals) is a sustained-release intravitreal insert that combines vorolanib with the bioerodible Durasert E drug delivery platform and is designed to deliver a daily therapeutic dose for at least 6 months.19,20 Each insert is composed of 94% drug and 6% matrix; the matrix is designed to prevent free-floating drug particles and does not contain polyethylene glycol (PEG) or polylactic-co-glycolic acid (PLGA).19,20 Duravyu is administered intravitreally using a preloaded syringe injector. In preclinical studies, vorolanib is measurable in target tissues within hours of administration.21,22
Duravyu has been evaluated in more than 190 patients across one phase 1 and three phase 2 trials.19,20,23-24 In the multicenter, randomized phase 2 DAVIO 2 (NCT05381948) trial, an injection of 2 doses of EYP-1901 (2 mg [n=53] or 3 mg [n=54]) was evaluated against aflibercept 2 mg every 8 weeks (q8W; n=54) in patients with previously treated nAMD.23,25 Both Duravyu doses showed consistent and sustained vision and anatomic outcomes at month 8, 6 months after Duravyu injection, with vision outcomes statistically noninferior to aflibercept q8W. Change from baseline in vision and CST were +1.0 and +0.9 letters (difference vs aflibercept q8W −0.3, −0.4 letters [noninferiority margin: −4.5 letters]), and +17.8 µm and +10.6 µm with Duravyu 2 mg and 3 mg, respectively.23,25,26 Up to 6 months after a single dose of Duravyu, 63% of patients remained supplement free.23,25 Compared with the 6 months before study, treatment burden reductions of 89% and 85% were observed at 6 months after Duravyu treatment.26 Similarly, in the phase 2 VERONA (NCT06099184) trial for DME, best-corrected visual acuity (BCVA) improvements of +6.9 and +7.1 letters were reported for Duravyu 1.3 mg (n=10) and 2.7 mg (n=11), respectively, at week 24 with central subfield thickness (CST) reductions of −71.1 µm and 75.9 µm.20 Up to week 24, 60% of Duravyu 1.3 mg and 73% of Duravyu 2.7 mg patients were supplemental injection-free.20 Across both trials no safety signals nor ocular serious adverse events (SAEs) related to Duravyu were reported.20,23,25 Based on learnings from these trials, phase 3 trials LUGANO (NCT06668064) and LUCIA (NCT06683742) for nAMD are evaluating Duravyu 2.7 mg with redosing every 6 months vs aflibercept q8W for nAMD. Topline 56-week data from LUGANO are expected in mid-2026 with LUCIA to follow.27,28 Duravyu 2.7 mg with redosing every 6 months will also be evaluated for DME in 2 identical noninferiority phase 3 trials, with first patient dosing anticipated in first quarter of 2026.29
Axitinib is being evaluated in 3 investigational products: Axpaxli (OTX-TKI; Ocular Therapeutics), CLS-AX (Clearside Biomedical), and SR-14034 (Alcon Research). Axpaxli combines axitinib with Elutyx, a bioresorbable soft PEG hydrogel intravitreal insert designed for drug release over 6 to 12 months.30-32 Drug is released via steady-state diffusion until hydrogel bioresorption occurs at 8 to 9 months.30 Axpaxli is administered via intravitreal injection.30 Axpaxli was investigated in two phase 1 trials for nAMD (Australia-based, NCT03630315; US-based, NCT04989699).33-35 The Australia-based trial was an open-label dose-ranging trial in both previously treated and treatment-naive patients conducted at 5 sites (n=23); the US-based trial was a randomized double-masked trial comparing a single dose of Axpaxli (n=15) with aflibercept q8W (n=5) conducted at 6 sites.33-35 In both trials, Axpaxli maintained vision compared with baseline with mean BCVA change from baseline of +1.1 letters at 6 months (Australia) and −1.3 letters at 7 months (United States).33-35 At months 6 and 7, Axpaxli maintained or improved CST with change from baseline of −101.3 µm (Australia) and +9.2 µm (United States). Through month 6 in both trials, 61% and 80% of patients remained supplement free.33-35 In the US-based trial, an anti-VEGF treatment burden reduction of 93% was observed at month 7 vs pretrial treatment.35 Across both trials, no drug-related SAEs were reported. In the Australia-based trial, 2 systemic SAEs were reported, with none reported in the US-based trial.33-35
Axpaxli is being further evaluated in the phase 3 trials SOL-1 (NCT06223958) and SOL-R (NCT06495918).36 SOL-1 completed enrollment and randomization; SOL-R completed enrollment with randomization ongoing. Top-line data are expected in Q1 202636 and H1 2027, respectively.37
Axitinib is also being investigated in CLS-AX. Unlike the intravitreal insert delivery method of the previous 2 products, CLS-AX consists of axitinib suspended in a proprietary suspension formation designed for administration via Clearside’s SCS Microinjector for suprachoroidal delivery.38 Injection into the suprachoroidal space targets the drug suspension to the back of the eye;39,40 this compartmentalizes the drug away from off-target tissues and fully behind the visual field, reducing the risk of floaters and other visual disturbances that may occur with intravitreal injections. SCS may also allow for more direct targeting of key tissues with a higher drug concentration than that of an intravitreal injection.39,40 CLS-AX was investigated in the phase 1/2a trial OASIS (NCT04626128) and its extension (NCT05131646), and the phase 2b trial Odyssey (NCT05891548). In OASIS, vision and CST were stable through months 3 and 6 in the initial trial and extension, respectively.41,42 The phase 2b ODYSSEY trial was a randomized, double-masked trial of CLS-AX 1.0 mg (n=40) vs aflibercept 2 mg q8W (n=20) conducted at 32 sites.38,43 At week 36 after treatment, BCVA and CST were maintained with changes from baseline of −1.9 letters and +8.0 µm.38 Through 24 weeks, 67% of patients were supplement-free with a reduction in injection treatment burden of 84%.38 Across trials, no ocular SAEs or treatment-related SAEs were reported.38
The third product investigating axitinib for nAMD is AR-14034, which combines axitinib with a bioerodible polymer implant for sustained drug release.44,45 The safety and durability of AR-14034 is currently being investigated in the 2-stage, dose-escalation phase 1/2 NOVA-1 trial (NCT05769153) being conducted at 44 US locations.46
Contrasting with the above products with ocular administration, migaldendranib (D-4517.2; Ashvattha Therapeutics) has been designed for subcutaneous injection and consists of a TKI analog covalently linked to a hydroxyl group. The hydroxyl group targets the molecule specifically for uptake into retinal pigment epithelial cells, macrophages, and microglia in choroidal neovascular lesions where it is retained for up to 30 days. Further, due to the hydroxyl group, migaldendranib bypasses the liver and is renally excreted to reduce hepatic AEs previously observed with systemic administration of TKIs. After a phase 1 trial,16 migaldendranib is currently being evaluated in an open-label trial conducted at 16 locations in previously treated patients (NCT05387837).47 At the 40-week end-of-study analysis, migaldendranib displayed visual and anatomic improvements in both indications (nAMD, n=14; DME, n=8).48 At week 40, BCVA and CST changes of +6.1 letters and −23.3 µm were reported for DME patients. Improvements in BCVA and CST were also observed in the nAMD group.48 Across both indications, an ~80% treatment burden reduction was seen at week 40.48 Migaldendranib was well tolerated with no treatment-related systemic or ocular serious adverse effects.48
Next Steps for Treatment Options
The efficacy results and favorable safety profiles reported in these clinical trials show promise for TKIs for treatment of retinal exudative diseases, particularly nAMD and DME. With vision and anatomic results comparable with current treatments and highly reduced treatment burden, TKIs have potential to address the undertreatment and treatment burden experienced by patients in clinical practice.
With phase 3 trials in progress for several of these products, additional data will be available that will further elucidate the potential placement for TKIs in the therapeutic landscape and treatment regimens. We look forward to seeing these results reported in the upcoming years. RP
References
1. Bakri SJ, Lynch J, Howard-Sparks M, et al. Vorolanib, sunitinib, and axitinib: A comparative study of vascular endothelial growth factor receptor inhibitors and their anti-angiogenic effects. PLoS One 2024;19(6):e0304782. doi:10.1371/journal.pone.0304782
2. Nguyen QD, Heier JS, Do DV, et al. The Tie2 signaling pathway in retinal vascular diseases: a novel therapeutic target in the eye. Int J Retina Vitreous 2020;6:48. doi:10.1186/s40942-020-00250-z
3. Ferrara N. VEGF and Intraocular Neovascularization: From Discovery to Therapy. Transl Vis Sci Technol 2016;5(2):10. doi:10.1167/tvst.5.2.10
4. Yang JY, Goldberg D, Sobrin L. Interleukin-6 and macular edema: a review of outcomes with inhibition. International Journal of Molecular Sciences 2023;24(5):4676.
5. Sepah YJ, Do DV, Mesquida M, et al. Aqueous humour interleukin-6 and vision outcomes with anti-vascular endothelial growth factor therapy. Eye 2024;38(9):1755-1761.
6. Funatsu H, Noma H, Mimura T, et al. Association of vitreous inflammatory factors with diabetic macular edema. Ophthalmology 2009;116(1):73-79.
7. Manda A, Lee LH, Steinkerchner M, et al. Analysis of aqueous interleukin-6 in diabetic retinopathy: a prospective, controlled trial of 328 eyes. Ophthalmology Retina 2025
8. LUCENTIS (ranibizumab). Prescribing Information. Genentech Inc.; Last updated: 2014.
9. EYLEA (aflibercept). Prescribing Information. Regeneron Pharmaceuticals Inc.; Last updated: 2024.
10. Ciulla TA, Pollack JS, Williams DF. Visual acuity outcomes and anti-VEGF therapy intensity in diabetic macular oedema: a real-world analysis of 28 658 patient eyes. Br J Ophthalmol 2021;105(2):216-221. doi:10.1136/bjophthalmol-2020-315933
11. Wykoff CC, Garmo V, Tabano D, et al. Impact of anti-VEGF treatment and patient characteristics on vision outcomes in neovascular age-related macular degeneration: up to 6-year analysis of the AAO IRIS Registry. Ophthalmol Sci 2024;4(2):100421. doi:10.1016/j.xops.2023.100421
12. EYLEA HD (aflibercept). Prescribing Information. Regeneron Pharmaceuticals Inc.; Last updated: 2024.
13. VABYSMO (faricimab). Prescribing Information. Genentech Inc.; Last updated: 2024.
14. SUSVIMO (ranibizumab injection). Prescribing Information. Genentech Inc.; Last updated: 2025.
15. Thomson RJ, Moshirfar M, Ronquillo Y. Tyrosine Kinase Inhibitors. StatPearls. Treasure Island (FL)2025.
16. Cleland JL, Sharma R, Appiania S, et al. Safety and tolerability of a single subcutaneous dose of anti-angiogenesis drug to treat neovascular age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Invest Ophthalmol Vis Sci. 2022;63:1347-F0184.
17. Duker JS. Duravyu™: Sustained-Release, Multi-MoA TKI with the Potential to Fulfill the Unmet Needs in DME and Wet AMD. Presented at: American Academy of Ophthalmology: Eyecelerator; October 16, 2025; Orlando, Florida. Accessed October 21, 2025. https://eyepointpharma.com/wp-content/uploads/2025/10/EyePoint_Eyecelerator_AAO-2025_25101601.pdf.
18. Cohen MN, O’Shaughnessy D, Fisher K, et al. APEX: a phase II randomised clinical trial evaluating the safety and preliminary efficacy of oral X-82 to treat exudative age-related macular degeneration. Br J Ophthalmol 2021;105(5):716-22. doi:10.1136/bjophthalmol-2020-316511
19. Patel S, Storey PP, Barakat MR, et al. Phase I DAVIO trial: EYP-1901 bioerodible, sustained-delivery vorolanib insert in patients with wet age-related macular degeneration. Ophthalmol Sci. 2024;4(5):100527. doi:10.1016/j.xops.2024.100527
20. Regillo CD. VERONA: results from a phase 2 trial of DuravyuDuravyu (vorolanib intravitreal insert vs aflibercept for diabetic macular edema. Presented at: Clinical Trials at the Summit; June 21, 2025; Las Vegas, Nevada. Accessed July 15, 2025. https://eyepointpharma.com/wp-content/uploads/2025/06/CTS_VERONA_Regillo_FINAL.pdf.
21. Hsieh T, Kupperman BD, Howard-Sparks M, et al. Plasma pharmacokinetics of single- and repeat-dose intravitreal EYP-1901 (vorolanib in Durasert) in rabbits over 12 months. Invest Ophthalmol Vis Sci. 2024;65:718.
22. Kupperman BD, Howard-Sparks M, Lynch J, et al. Design and function of EYP-1901, a sustained-release platform for retinal/choroidal diseases: pan–vascular endothelial growth factor receptor inhibitor vorolanib in a bioerodible intravitreal insert. Investigative Ophthalmology & Visual Science 2024;65:1938.
23. Eichenbaum DA. 12-MONTH RESULTS FROM THE DAVIO 2 TRIAL: A phase 2, multicenter study of a single injection of EYP-1901 (vorolanib intravitreal insert) vs aflibercept for previously treated patients with wet age-related macular degeneration. Presented at: Retina Society Annual Meeting; September 11-15, 2024; Lisbon, Portugal. Accessed July 15, 2025. https://eyepointpharma.com/wp-content/uploads/2025/02/RetSoc-2024_DAVIO2-1yr_Eichenbaum_Presentation_FINAL_For-Website.pdf.
24. Almeida D, Ribeiro R. PAVIA phase 2 trial of EYP-1901 in nonproliferative diabetic retinopathy: 12-month results. Invest Ophthalmol Vis Sci.2025;66(8):4762.
25. Regillo CD. EYP-1901 for the treatment of wet AMD: phase 2 DAVIO 2 end-of-study results. Presented at: American Academy of Ophthalmology retina subspecialty day; October 18-19, 2024; Chicago, Illinois. Accessed July 15, 2025. https://eyepointpharma.com/wp-content/uploads/2024/10/AAOSSD-2024_DAVIO2-1yr_Regillo_Presentation.pdf.
26. Abbey A. DAVIO 2: year 1 results from a phase 2, multicenter, non-inferiority trial of EYP-1901 (vorolanib intravitreal insert) vs aflibercept for previously treated wet age-related macular degeneration. Presented at: Hawaiian Eye and Retina; January 18-24, 2025; Koloa, Hawaii. Accessed July 13, 2025. https://eyepointpharma.com/wp-content/uploads/2025/02/HIEye2024_25012001.pdf.
27. EyePoint Pharmaceuticals. EyePoint Completes Enrollment in Pivotal Phase 3 LUGANO Trial of Duravyu™ for Treatment of Wet Age-Related Macular Degeneration. Press release. May 27, 2025. Accessed July 15, 2025. https://investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-completes-enrollment-pivotal-phase-3-lugano-trial.
28. EyePoint Pharmaceuticals. EyePoint Completes Enrollment of Pivotal Phase 3 Trials for Duravyu™ in Wet Age-Related Macular Degeneration. Press release. July 29, 2025. Accessed July 29, 2025. https://investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-completes-enrollment-pivotal-phase-3-trials-duravyutm.
29. EyePoint Pharmaceuticals. EyePoint Announces Pivotal Phase 3 Program Initiation for Duravyu™ in Diabetic Macular Edema. Press release. October 14, 2025. Accessed October 15, 2025. https://investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-announces-pivotal-phase-3-program-initiation-duravyutm.
30. Blizzard C, Patel C, Patil M, et al. PHARMACODYNAMIC EFFICACY OF OPTIMIZED INTRAVITREAL AXITINIB IMPLANT (OTX-TKI) IN A VEGF CHALLENGE RABBIT MODEL. Presented at: ARVO; May 5-9, 2024; Seattle, Washington. Accessed July 15, 2024. https://investors.ocutx.com/static-files/4ab97f8b-adf0-4acf-8e3d-2bd7c1441fb2.
31. Schlottmann P. Sustained-Release Axitinib Hydrogel (OTX-TKI) for Wet AMD: US Phase 1 Study Results. Presented at: Clinical Trials at the Summit; June 21, 2025; Las Vegas, Nevada. Accessed July 15, 2025. https://investors.ocutx.com/static-files/d9e143a4-4054-4ade-9ad3-edcebbaba93f.
32. Wykoff CC, Kuppermann BD, Regillo CD, et al. Extended Intraocular Drug-Delivery Platforms for the Treatment of Retinal and Choroidal Diseases. J Vitreoretin Dis 2024;8(5):577-86. doi: 10.1177/24741264241267065.
33. Moshfeghi AA. Phase 1 Trial of a Novel, Hydrogel-based, Intravitreal AxitinibImplant for the Treatment of Neovascular Age-related Macular Degeneration. Presented at: American Academy of Opthalmology; November 12-15, 2021; New Orleans, Louisiana. Accessed July 15, 2025. https://investors.ocutx.com/static-files/7fbcac09-dd2b-4111-a3f1-39a173e4d9e4.
34. Moshfeghi AA. Australia-based Phase 1 Trial of a Novel, Hydrogel-based, Intravitreal Axitinib Implant for the Treatment of Neovascular Age-related Macular Degeneration. Presented at: American Academy of Ophthalmology; September 30-October 2, 2022; Chicago, Illinois. Accessed July 15, 2025.
35. Dhoot DS. Interim Safety and Efficacy Data from a Phase 1 Clinical Trial of Sustained-release Axitinib Hydrogel Implant (OTX-TKI) in Wet AMD Subjects: 7-month Analysis. Presented at: American Academy of Ophthalmology: Retina Subspecialty Day; September 30, 2022; Chicago, Illinois. Accessed July 15, 2025. https://investors.ocutx.com/static-files/2ede9647-0109-4b51-b204-823d19cbaa86.
36. Gibson A. SOL-1 & SOL-R Pivotal Phase 3 Trials Evaluating OTX-TKI for wAMD. Presented at: Clinical Trials at the Summit, June 21, 2025;. Las Vegas, Nevada. Accessed July 15, 2025. https://investors.ocutx.com/static-files/0ca6958b-a3aa-44ef-9603-9d7c85a7a865.
37. Ocular Therapuetix. Ocular Therapeutix™ Investor Day to Highlight Exceptional Axpaxli™ Progress Across SOL Program and Detail Registrational Trial Plans to Pursue a Diabetic Retinopathy Label with a Novel Primary Endpoint. Press release. September 30, 2025. Accessed October 15, 2025. https://investors.ocutx.com/news-releases/news-release-details/ocular-therapeutixtm-investor-day-highlight-exceptional.
38. Clearside Biomedical. ODYSSEY Topline Data Results Conference Call/Webcast; October 9, 2024. Accessed July 15, 2025. https://clearsidebio.com/wp-content/uploads/2024/10/ODYSSEY-Topline-Data-Presentation-Final-10.09.24.pdf.
39. Chiang B, Jung JH, Prausnitz MR. The suprachoroidal space as a route of administration to the posterior segment of the eye. Adv Drug Deliv Rev 2018;126:58-66. doi: 10.1016/j.addr.2018.03.001.
40. Moisseiev E, Loewenstein A, Yiu G. The suprachoroidal space: from potential space to a space with potential. Clin Ophthalmol 2016;10:173-8. doi: 10.2147/OPTH.S89784.
41. Clearside Biomedical. OASIS Phase 1/2a Clinical Trial: 3-Month Final & 6-Month Interim Results; November 9, 2022. Accessed July 15, 2025. https://clearsidebio.com/wp-content/uploads/2024/02/OASIS-3-Month-Final-6-Month-Interim-Results-Presentation-11.9.22.pdf.
42. Clearside Biomedical. OASIS Phase 1/2a Clinical Trial 6-Month Extension Study Results; February 2, 2023. Accessed July 15, 2025. https://clearsidebio.com/wp-content/uploads/2024/02/OASIS-Extension-Study-Results-2.2.23.pdf.
43. Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration (ODYSSEY). ClinicalTrials.gov identifier: NCT05891548. Updated July 25, 2025. Accessed July 29, 2025. https://clinicaltrials.gov/study/NCT05891548.
44. Muste JC, Talcott KE. Novel Therapeutics for Neovascular AMD. Retinal Physician, 2025:16-19.
45. Weksler M, McDougal A, Williams S, et al. AR-14034 SR Implant Inhibits Retinal Vascular Leakage In A VEGF Challenge Model For Up To 12 Months. Investigative Ophthalmology & Visual Science 2023;64:2114.
46. Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD) (NOVA-1). ClinicalTrials.gov identifier: NCT05769153. Updated July 29, 2025. Accessed July 30, 2025. https://clinicaltrials.gov/study/NCT05769153.
47. Safety, Tolerability and PK of Subcutaneous D-4517.2 in Subjects With Wet AMD or DME (Tejas). ClinicalTrials.gov identifier: NCT05387837. Last updated May 4, 2025. Accessed July 29, 2025.https://clinicaltrials.gov/study/NCT05387837.
48. A shvattha Therapeutics. Ashvattha Therapeutics Announces Positive Topline 40-Week Phase 2 Results for Migaldendranib in Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration. Press release. September 4, 2025. Accessed October 15, 2025. https://avttx.com/ashvattha-therapeutics-announces-positive-topline-40-week-phase-2-results-for-migaldendranib-in-diabetic-macular-edema-and-neovascular-age-related-macular-degeneration/.