Ophthalmology Times

07/22/2025

Viatris announced that its phase 3 study to evaluate the efficacy and safety of pimecrolimus 0.3% (MR-139) ophthalmic ointment in subjects with blepharitis did not meet the primary endpoint.

The MR-139 3001 phase 3 trial (NCT06400511) was a randomized, placebo-controlled, double-masked prospective study, with a total of 477 patients randomized to receive either MR-139 or placebo, self-administered to the eyelids twice daily. Patients were treated and observed over 12 weeks.

Read More:

The primary end point of the trial was complete resolution of debris after 6 weeks of twice-daily dosing.

07/22/2025

A new Chinese investigation found that attention-deficit hyperactivity disorder (ADHD) is associated with reduced myopia prevalence, more hyperopic spherical equivalent refraction (SER), and shorter axial length (AL) in schoolchildren, according to Xiu Nian Chen, PhD, from the Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong.

Chen and colleagues explained that increased risks of astigmatism, strabismus, reduced near point of convergence, color discrimination, and contrast sensitivity have been reported in patients with ADHD. This is noteworthy considering that myopia is the most common ocular disease worldwide, with a heavy public health burden in many parts of the world.

Read More:

Authors noted it may be worthwhile to explore whether oral methylphenidate affects myopia by influencing dopamine levels

07/21/2025

Nicox and Kowa have entered into an agreement regarding NCX 470, Nicox’s nitric oxide (NO)-donating bimatoprost eye drop, for the lowering of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.

According to the agreement, Kowa receives exclusive rights to develop and commercialize NCX 470 in the US and all other territories of the world excluding Japan, China, Korea, and Southeast Asia. Kowa already has a license to NCX 470 for Japan, where it is preparing to enter a phase 3 clinical trial.

NCX 470 is currently licensed to Ocumension Therapeutics for China, Korea, and Southeast Asia.

Read More:

Under the terms of the agreement, Kowa receives exclusive rights to develop and commercialize NCX 470 in the US and all other territories of the world excluding Japan, China, Korea, and Southeast Asia.

07/21/2025

OKYO Pharma has announced positive top-line data from the recently closed phase 2 trial of urcosimod (formerly called OK-101) to treat neuropathic corneal pain (NCP).

The company describes urcosimod as a lipid-conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor, which is typically found on immune cells of the eye responsible for the inflammatory response, as well as on neurons and glial cells in the dorsal root ganglion.

Urcosimod is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor.

07/20/2025

AAVantgarde Bio recently announced the US Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for AAVB-039. AAVB-039 is AAVantgarde’s gene therapy program for the treatment of Stargardt disease. AAVantgarde is a clinical-stage biotechnology company focused on developing gene therapies for the treatment of inherited retinal disease.

“This FDA clearance marks a pivotal milestone for AAVantgarde and our Stargardt program,” Natalia Misciattelli, PhD, chief executive officer of AAVantgarde, said in a press release.

AAVB-039 advances gene therapy for Stargardt disease, aiming for innovative treatments for inherited retinal disorders.

07/20/2025

The US Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ocular reproxalap for the treatment of signs and symptoms of dry eye disease from Aldeyra Therapeutics.

Aldeyra resubmitted its NDA to the FDA in June 20252 after it received 2 complete response letters (CRL) from the FDA in April 2025 and November 2023 for past submissions.

Read More:

A Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2025, was assigned by the FDA.

07/19/2025

The US Food and Drug Administration (FDA) recently granted fast track designation to Sanofi’s SAR446597 for the treatment of geographic atrophy (GA).

SAR446597 is a one-time intravitreal gene therapy treatment that “delivers genetic material encoding 2 therapeutic antibody fragments that target and inhibit 2 critical components of the complement pathway: C1s in the classical pathway and factor Bb in the alternative pathway,” a press release said

Read More:

SAR446597 is a one-time intravitreal gene therapy treatment for the treatment of geographic atrophy

07/19/2025

Samsung Bioepis and Harrow have entered into a license, development, and commercialization agreement (DCA). In the agreement, Harrow will secure the exclusive US commercial rights to the ophthalmology biosimilar portfolio of Samsung Bioepis—ranibizumab-nuna 0.05 mL injection (BYOOVIZ), an FDA-approved biosimilar referencing LUCENTIS (ranibizumab), and aflibercept-yszy 0.05 mL injection (OPUVIZ), an FDA-approved biosimilar referencing EYLEA (aflibercept).

The commercial license will become effective upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis, which is expected to be completed by the end of 2025, according to Samsung Bioepis.

Read More:

Included in the agreement are ranibizumab-nuna 0.05 mL injection (BYOOVIZ), referencing LUCENTIS (ranibizumab), and aflibercept-yszy 0.05 mL injection (OPUVIZ), referencing EYLEA (aflibercept).

07/18/2025

The second part in the series celebrating Ophthalmology Times' 50th anniversary, where we invited top experts to reflect on the most significant innovations in ophthalmology over the past five decades.

To mark Ophthalmology Times' 50th anniversary, we invited top experts to reflect on the most significant innovations in ophthalmology over the past five decades.

07/18/2025

A Chinese investigation emphasized the importance of eradicating secondhand smoke to prevent the development of myopia in children, reported first author Yuchang Lu, MD.

Lu and colleagues pointed out that although the mechanism of myopia is not fully understood, genetic and environmental factors are believed to influence its development.“ Investigating the risk factors for myopia and enhancing modifiable environmental predictors are crucial for mitigating the myopia epidemic,” they stated in their article in BMC Ophthalmology.

Read More:

A Chinese study reveals that secondhand smoke exposure significantly increases the risk of early-onset myopia in children

07/17/2025

Meet Joseph Allen, OD, FAAO, Dipl ABO, Founder at Doctor Eye Health, and a member of the EyeCon 2025 educational committee!

Join him from September 26–27 at the Margaritaville Hollywood Beach Resort. Engage with top educators, hear the latest advances in eye care, and network with your peers. Earn up to 14 CME/COPE credits as you enjoy the beautiful weather at Hollywood Beach.

Sign up NOW! Click here: https://hubs.li/Q03xhNdQ0

Don’t miss the chance to connect and grow with the eye care community! Use code ALLEN for 50% off of your registration!

07/17/2025

Spherix Global Insights released data that examine the competitive and complex treatment landscape for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).

The Q2 wave of the syndicated RealTime Dynamix studies shows current prescribing dynamics, perceptions of leading therapies, and evolving expectations shaped by emerging treatments and payer influence.

Read More:

The survey shows the evolving landscape of nAMD and DME treatments, highlighting physician preferences, payer influences, and the promise of gene therapy advancements.