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Tyrosine Kinase Inhibitors to Prolong Efficacy of Anti-VEGF Therapies

Video content above is prompted by the following:

If TKIs become available, how would this impact the relative benefits of PDS?

Panelists explore how the introduction of tyrosine kinase inhibitors (TKIs) could affect the perceived benefits of the port delivery system, as these agents may offer an alternative approach to reducing injection burden while potentially providing broader therapeutic effects.

clinical

Tyrosine Kinase Inhibitors to Prolong Efficacy of Anti-VEGF  Therapies

Vantage Biosciences has successfully dosed the first patient in its phase 2 clinical study evaluating VX-01, an oral therapy for the treatment of 

non-proliferative diabetic retinopathy (NPDR)

VX01-DR-201, is a phase 2, multi-center, double-masked, randomized, placebo-controlled study designed to evaluate the efficacy of oral dose of VX-01 in patients with moderate to severe NPDR without 

center-involved diabetic macular edema (CI-DME).

 Participants will be randomized 1:1 into 1 of 2 study cohorts and will take VX-01 or placebo BID for 52 consecutive weeks, followed by a 12-week post-treatment observation period.

VX-01 is an orally administered small molecule therapy designed to target neurovascular inflammation associated with diabetic eye disease and aims to slow or prevent disease progression in NPDR patients before irreversible vision loss occurs.

Alek Safarian, co-founder and chairman of Vantage Biosciences, commented on the trial in a press release from the company, saying, “We are pleased to initiate patient dosing in this important phase 2 study, which evaluates VX-01 as a potential early intervention for diabetic retinopathy. By targeting the disease at an earlier stage, VX-01 has the potential to slow or prevent progression to more severe forms of diabetic retinopathy, reducing the likelihood that patients will require invasive treatments in the future.”

The company stated that the study is expected to read out in 2027 and is being run at 27 sites across the US, Australia, and a number of Southeast Asian countries.

Vantage Biosciences doses first patient in phase 2 clinical study of oral VX-01 for non-proliferative diabetic retinopathy. Published April 11, 2025. Accessed April 11, 2025. 

https://www.globenewswire.com/news-release/2025/04/11/3059941/0/en/Vantage-Biosciences-Doses-First-Patient-in-Phase-2-Clinical-Study-of-Oral-VX-01-for-Non-Proliferative-Diabetic-Retinopathy.html

VX01-DR-201, is a phase 2, multi-center, double-masked, randomized, placebo-controlled study in patients with moderate to severe NPDR without center-involved diabetic macular edema (CI-DME).

Canonical

First patient dosed in Vantage Biosciences' phase 2 study of VX-01 for nonproliferative diabetic retinopathy

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Aldeyra Therapeutics for its resubmission of the New Drug Application (NDA) of reproxalap for the treatment of dry eye disease.

Aldeyra previously conducted 2 trials for ocular redness in a dry eye chamber, and two dry eye disease symptom field (environmental exposure) trials, which were submitted as part of an initial NDA in November 2022.

Aldeyra received a CRL for its initial NDA for reproxalap

 While no safety or manufacturing issues with reproxalap were identified, the FDA stated in the letter that the NDA did not demonstrate “efficacy in treating ocular symptoms associated with dry eyes” and that “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye” should be conducted.

FDA accepted the most recent NDA from Aldeyra in November of 2024

 The new NDA featured previously disclosed positive results from a recently completed dry eye disease symptom trial that was requested by the FDA following a review of the previous NDA. The application also includes a draft label reflecting acute activity in reducing dry eye symptoms in a dry eye chamber trial, chronic activity in reducing dry eye symptoms in a field trial, and acute activity in reducing ocular redness in 2 dry eye chamber trials.

In the recent NDA, the FDA found no manufacturing or safety issues with reproxalap. However, the FDA stated in the CRL that the NDA “failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes” and that “at least one additional adequate and well controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye” should be conducted, mirroring their previous CRL.

Furthermore, Aldeyra stated the letter identified “concerns with the data from the trial submitted to the NDA that may have affected interpretation of the results,” which the FDA stated may be related to methodological issues, including a difference in baseline scores across treatment arms.

According to the company, a Type A meeting is expected to be held within approximately 30 days to discuss the CRL for the resubmitted NDA and the ongoing clinical trials of reproxalap in dry eye disease.

Todd C. Brady, MD, PhD, president and CEO of Aldeyra Therapeutics commented on the status of the NDA in a press release from the company.

“Pending positive results from the ongoing clinical trials and discussions with the FDA, we look forward to a potential NDA resubmission mid-year 2025,” stated Brady. “Reproxalap remains the only late-stage topical ocular therapy suitable for chronic administration to have potentially demonstrated acute reduction in ocular redness, as well as reduction in ocular discomfort, highlighting rapid and broad activity for both the signs and symptoms of dry eye disease.”

Aldeyra expects to announce top-line results from the ongoing dry eye disease field trial and the ongoing chamber clinical trial in Q2 of 2025. Pending positive results from those trials, the company plans to resubmit the NDA mid-year 2025.

Aldeyra Therapeutics receives complete response letter from the U.S. Food and Drug Administration for the reproxalap new drug application for the treatment of signs and symptoms of dry eye disease. Published April 3, 2025. Accessed April 3, 2025. 

https://ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-receives-complete-response-letter-us-food-0

Hutton D. Aldeyra Therapeutics receives complete response letter from FDA for reproxalap NDA. Ophthalmology Times. Published November 29, 2023. Accessed April 3, 2025. 

https://www.ophthalmologytimes.com/view/aldeyra-therapeutics-receives-complete-response-letter-from-fda-for-reproxalap-nda

Harp M. Maharjan E K. FDA accepts NDA from Aldeyra Therapeutics for reproxalap for dry eye. Published November 19, 2025. Accessed April 3, 2025. 

https://www.ophthalmologytimes.com/view/fda-accepts-nda-from-aldeyra-therapeutics-for-reproxalap-for-dry-eye

The company stated that the FDA noted at least 1 additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye should be conducted.

FDA issues complete response letter to Aldeyra Therapeutics for resubmitted new drug application of reproxalap

A study of the effects of methylphenidate in children with attention deficit hyperactivity disorder (ADHD) found lower corneal endothelial cell counts in those diagnosed with ADHD and undergoing treatment with methylphenidate compared with untreated children and a control group. The authors also reported that the ganglion cell layer (GCL) measurements were lower in the untreated children who were diagnosed with ADHD compared with those receiving methylphenidate and the control group. 

, MD, and colleagues from the Department of Ophthalmology, Medical Faculty, Karadeniz Technical University, Trabzon, Turkey, reported their results in International Ophthalmology.

Methylphenidate isa central nervous system stimulant that is used to treat ADHD, a very common diagnosis in children in the US.

This study focused on elucidating the ocular effects of methylphenidate on children diagnosed with ADHD and healthy controls. The participants were divided as follows: those diagnosed with ADHD and undergoing methylphenidate therapy (group 1), newly diagnosed untreated patients (group 2), and healthy, controls (group 3). The researchers evaluated the morphology and numbers of corneal endothelial cells, corneal thickness, choroidal thickness (CT), retinal thickness (RT), GCL, and retinal nerve fiber layer (RNFL) were evaluated.

Group 1 included 30 children (mean age, 10.53 ± 2.78years) with ADHD treated with methylphenidate for a minimum of 1 year; group 2 included 32 newly diagnosed untreated children (mean age, 9.21 ± 1.85 years);and group 3 included 35 healthy children (mean age, 11.03 ± 3.01 years).

While the groups did not differ significantly (P > 0.05) in age, visual acuity level, or refractions, the researchers found that the endothelial cell counts and hexagonality values differed significantly between groups 1 and 2 (P = 0.041 andP= 0.031, respectively).

Other observations were that the GCL values differed between groups 1 and 2 and between groups 2 and 3 (P = 0.0001 andP = 0.02, respectively), but not between groups 1 and 3 (P = 0.551), the researchers reported.

The other parameters evaluated, i.e., the central CT, central RT, and mean RNFL values did not differ significantly among the three groups (P > 0.05).

Uzlu and colleagues concluded, “Corneal endothelial counts were lower in the children diagnosed with ADHD and receiving methylphenidate therapy than in those not receiving treatment and the control group. In addition, GCL measurements were lower in the children diagnosed with ADHD and not using medication compared to those using methylphenidate and the control group.”

1. Uzlu D, Bilginer SÇ, Yaşar Y, et al.An examination of the ocular effects of methylphenidate used in children and adolescents diagnosed with attention-deficit hyperactivity disorder.Int Ophthalmol. 2025;45. 

https://doi.org/10.1007/s10792-025-03471-z

A study on the effects of methylphenidate in children with ADHD found that treated children had lower corneal endothelial cell counts compared to untreated children and a control group. 

Ocular effects of methylphenidate in children and adolescents with ADHD 

 emphasized the importance of early recognition of the ocular signs of multiple myeloma because early diagnosis and treatment may have a positive impact on the disease course, according to coauthors Matteo Ripa, MD, and Chiara Schipa, MD, who, respectively, are from the Department of Ophthalmology, Sankara Eye Hospital, Jaipur, Rajasthan, India, and Catholic University “Sacro Cuore”, and the , Rome, Italy, the Department of Emergency, Anesthesiological and Reanimation Sciences, Fondazione Policlinico Universitario A. Gemelli Istituto di Ricovero e Cura a Carattere Scientifico, both in Rome.

Multiple myeloma is a rare cancer that originates in white blood cells (plasma cells) that produce antibodies.

The investigators conducted a literature review of PubMed, Scopus, and Embase to identify studies mentioning intraocular or extraocular manifestations of multiple myeloma with the goal of determining if they can be considered a disease hallmark to guide clinical decision-making. Cases were excluded that had other monoclonal gammopathies or therapy-related ocular effects. Ultimately, the investigators included 82 articles.

Ripa and Schipa and colleagues reported that “Ophthalmic manifestations may be the first sign or represent that the multiple myeloma is relapsing."

The literature search showed that “Several eyelid manifestations have been recognized that included “bilateral eyelid ecchymosis, cutaneous xanthomatosis, necrobiotic xanthogranuloma, localized lipid deposits, ptosis associated with diplopia, and eyelid ectropion,” they said.

Other findings included the presence of crystalline deposits throughout all layers of the cornea, including the epithelium, stroma, and endothelium of patients with multiple myeloma. A rarer finding in patients with multiple myeloma was copper deposition that was described as a greenish-brown deposit affecting the central cornea on Descemet’s membrane with unique characteristics.

The investigators also found that the retina and choroid can be affected in this patient population. Specifically, bilateral central retinal vein occlusion, choroidal effusion, ciliary body cysts, Purtscher’s retinopathy, and microvascular changes have been reported.

The research team underscored the importance of recognizing the ocular manifestations in patients with multiple myeloma to facilitate early diagnosis and treatment.

“…all patients diagnosed with multiple myeloma should undergo a thorough ophthalmic examination. Therefore, a close collaboration between hematologists and ophthalmologists could lead to earlier diagnoses and potentially impact the course of the disease,” the authors concluded.

1. Ripa M, Schipa C, Aceto P, Shah NA. Exploring the ocular involvement in multiple myeloma: a comprehensive review of 70-year clinical studies. 

https://doi.org/10.1007/s10792-025-03467-9

Ocular signs may be early indicators of multiple myeloma or relapse, and early recognition and collaboration between hematologists and ophthalmologists can improve outcomes.

Ocular involvement in multiple myeloma

Formosa Pharmaceuticals and Cipla Limited have entered into an exclusive licensing agreement for the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007) for post-operative inflammation and pain following ocular surgery.

Under the terms of the agreement, Cipla has exclusive rights to market APP13007 across 11 countries: India, Nepal, Sri Lanka, Bangladesh, Malaysia, Myanmar, Kenya, Nigeria, South Africa, Argentina, and Colombia.

approved by the US Food and Drug Administration (FDA) in March 2024

. It offers a twice-daily dosing regimen for 14 days without tapering, providing rapid and sustained relief from inflammation and pain.

 The rights to APP13007 have been split depending on the country, with numerous deals being made, and the deal with Cipla adds to the list.

 to the drug in August 2023 from Formosa. 

Cristália Products Químicos Farmacêuticos LTDA acquired exclusive Brazilian rights

 from Formosa in January 2024. In Canada, 

Apotex Inc. acquired exclusive rights in August 2024

Erick Co, president and CEO of Formosa Pharmaceuticals, and Achin Gupta, global chief operating officer of Cipla, both commented on the recent partnership in a press release.

"Formosa Pharma welcomes this partnership with Cipla, a well-renowned and respected global pharmaceutical brand. We appreciate their recognition and desire to add APP13007 to their rich portfolio of innovative medicines and look forward to working together to provide our novel therapy to ocular surgery patients to their audience," said Co.

"The partnership with Formosa Pharmaceuticals marks a significant milestone for Cipla, as it is our first multi-regional licensing agreement in ophthalmology. It reinforces our commitment to bringing cutting-edge treatments to patients worldwide. With exclusive rights to market APP13007 across 11 countries, we are excited to expand access to this innovative therapy and strengthen our ophthalmology portfolio,” said Gupta.

The strategic licensing agreement between Cipla and Formosa Pharmaceuticals includes upfront payments, royalty milestones, and additional value-driven considerations throughout its term.

Cipla and Formosa sign multi-regional licensing deal for Clobetasol Suspension. PRnewswire. Published March 18, 2025. Accessed March 20, 2025. 

https://www.prnewswire.com/news-releases/cipla-and-formosa-sign-multi-regional-licensing-deal-for-clobetasol-suspension-302403405.html

The recent agreement with Cipla adds to the list of partnerships Formosa has formed for APP13007.

Minzhong Yu, PhD, MMed

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