Glaukos Corp. has submitted its New Drug Application (NDA) to the Food and Drug Administration for Epioxa, its next-generation corneal cross-linking therapy for the treatment of keratoconus. The NDA submission includes data from two Phase III pivotal trials of Epioxa, both of which met the primary efficacy endpoints and demonstrated favorable tolerability and safety profiles. The company anticipates Epioxa could be the first FDA-approved, noninvasive corneal cross-linking therapy that does not require removal of the corneal epithelium.

Ocugen reports that its Data and Safety Monitoring Board (DSMB) has cleared continuation of the Phase I/II ArMaDa clinical trial of OCU410, a gene therapy designed as a one-time treatment for geographic atrophy caused by dry age-related macular degeneration. The DSMB reviewed data from 15 participants in the ongoing Phase II study and found that OCU410 demonstrated an acceptable safety and tolerability profile, Ocugen says. The trial, conducted in 13 US retinal centers, is evaluating the the safety and efficacy of OCU410 in 45 patients randomized into two dosing groups or a control group.

Regeneron Pharmaceuticals reports the Phase III QUASAR trial of Eylea HD (aflibercept 8 mg) for macular edema following retinal vein occlusion has met its primary endpoint, which consisted of equivalent improvement in visual acuity, compared to Eylea 2 mg at 36 weeks. Regeneron says the data will be submitted to regulatory authorities around the world, with a submission to the Food and Drug Administration planned for the first quarter of 2025.

Galimedix Therapeutics has launched the Phase II study of GAL-101 eye drops for treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration. The study is planned to enroll up to 110 patients, who will be randomized 1:1 to receive the study drug or placebo. The primary endpoint of the trial is reduction in rate of change of GA lesion size. The trial will also evaluate the reduction in rate of change in the area of photoreceptor degeneration and various functional outcome measures, including retinal sensitivity on microperimetry with patient-tailored grid design.

ViGeneron reports two key milestones for its gene therapy candidate VG901 to treat retinitis pigmentosa caused by mutations in the CNGA1 gene: The Food and Drug Administration has granted Rare Pediatric Disease Designation; and the independent Data Safety Monitoring Board has unanimously approved dose escalation in the ongoing Phase Ib clinical trial.

ViGeneron reports two key milestones for its gene therapy candidate VG901 to treat retinitis pigmentosa caused by mutations in the CNGA1 gene: The Food and Drug Administration has granted Rare Pediatric Disease Designation; and the independent Data Safety Monitoring Board has unanimously approved dose escalation in the ongoing Phase Ib clinical trial.

Tenpoint Therapeutics, which merged with Visus Therapeutics, has reported positive topline results from BRIO-II, the second Phase III pivotal trial of Brimochol PF for the treatment of presbyopia. Brimochol PF demonstrated statistically significant improvements in near vision versus vehicle at all timepoints out to eight hours. The trial also found Brimochol PF was well-tolerated over a 12-month daily dosing period with no treatment-related serious adverse events. An additional analysis found Brimochol PF significantly improved reading speed and patient-reported quality-of-life outcomes.

Ocular Therapeutix reports that it plans to seek feedback from the Food and Drug Administration in the first half of the year on the clinical trial design for Axpaxli in nonproliferative diabetic retinopathy.

Samsara Vision has reported intermediate-term visual and safety outcomes of the implantable SING IMT (Smaller-Incision New-Generation Implantable Miniature Telescope) in patients six months postsurgery. Overall, researchers found that SING IMT implantation improved distance and near vision, with a low impact on the corneal endothelium cell density and manageable safety outcomes. The results have been published in the journal Heliyon.

AbbVie and RegenxBio report that data from the pivotal clinical trials of ABBV-RGX-314 delivered subretinally in patients with neovascular age-related macular degeneration, known as ATMOSPHERE and ASCENT, are expected in 2026. Also, the partners say they are planning a Phase III program of AABV-RGX314 in diabetic retinopathy, delivered to the suprachoroidal space via the SCS Microinjector.

The Food and Drug Administration has approved Heidelberg Engineering’s Epithelial Thickness Module, available exclusively through the Anterion Cornea App. The module includes thickness mapping and data insights to evaluate both the epithelial and stromal structures in the clinic. It’s designed to support refractive surgery planning, evaluate the ocular surface, and aid in corneal ectasia assessment, as well as assist in other corneal diagnostics.

The FDA accepted the revised supplemental New Drug Application (sNDA) for Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy secondary to dry age-related macular degeneration. The sNDA seeks to add positive two-year data to the Izervay US prescribing information based on results from the GATHER2 Phase III clinical trial. The application was refiled following a meeting between the FDA and Astellas, and it has been designated as a Class 1 resubmission with a 60-day review period. A target action date has been set for February 26.

Zeiss MEL 90 excimer laser received FDA approval for all three major indications, including myopia, hyperopia and mixed astigmatism. The laser integrates into the Corneal Refractive Workflow and complements the Visumax 800 with SMILE pro from ZEISS. The MEL 90 excimer laser technology is equipped with an active eye tracker.

PulseSight Therapeutics has submitted a Clinical Trial Authorization to the medical products regulatory agency in France for a Phase I trial to evaluate the safety and tolerability of PST-611 in humans with geographic atrophy and dry age-related macular degeneration. The study is expected to start in Q2 2025, with a readout anticipated by the end of 2025 or early 2026, PulseSight reports.

Outlook Therapeutics reports it has completed the 12-week safety and efficacy results for NORSE EIGHT, the second of two clinical trials evaluating ONS-5010 in patients with neovascular age-related macular degeneration. ONS-5010 is an ophthalmic formulation of bevacizumab (Avastin, Genenetch/Roche). Outlook reports ONS-5010 demonstrated noninferiority to ranibizumab (Lucentis, Genentech/Roche) at week 12. Based on these results, Outlook says it plans to resubmit the Biologics License Application for ONS-5010 by March 31.

Inflammasome Therapeutics reports what it calls positive topline three-month data from a clinical trial of its K8 implant in patients with geographic atrophy (GA) secondary to dry age-related macular degeneration. The five patients with bilateral GA who received a K8 implant in one eye demonstrated a 66% average reduction in GA lesion growth with no drug-related safety issues. Patients will receive a second K8 injection at month three of the six-month trial. Based on this data, Inflammasome says it has expanded the trial to 30 patients (60 eyes).

The last patient has been examined in the Phase III study of  ST-100 (vezocolmitide), Stuart Therapeutics’ investigative candidate for treatment of dry eye disease. Topline data results are expected in February.

In the OCU200 Phase I clinical trial in diabetic macular edema, the first patient has been dosed, reports trial sponsor Ocugen. The trial is evaluating safety of OCU200 via intravitreal injection in three cohorts: low dose (0.025 mg); medium dose (0.05 mg); and high dose (0.1 mg). All subjects will receive two intravitreal injections six weeks apart, with patient follow-up taking place up to three months after the last injection.

The Food and Drug Administration has granted Rare Pediatric Disease Designation to AAV8-RK-RetGC, reports MeiraGTx Holdings. The investigative program aims to treat Leber congenital amaurosis due to GUCY2D mutations.

The FDA also granted Fast Track designation to NPI-001 (N-acetylcysteine amide) tablets, Nacuity Pharmaceuticals’ investigational therapy for the treatment of retinitis pigmentosa.

Health Canada has authorized Vabysmo (faricimab injection) for use in a 6-mg single-use prefilled syringe (PFS) to treat wet, or neovascular, age-related macular degeneration, diabetic macular edema, and macular edema secondary to retinal vein occlusion, Roche Canada reports. Vabysmo PFS will become available in Canada in the coming months, Roche Canada says.

Arcatus, a triamcinolone acetonide 4-mg/0.1-mL injection suspension vial kit for delivery to the back of the eye through the suprachoroidal space (SCS), has received regulatory approval in Australia and Singapore for the treatment of uveitic macular edema (UME), partners Arctic Vision and Clearside Biomedical, developer of the SCS platform, announce. Arctic is a China-based ophthalmic biotech that has the exclusive license for the commercialization and development of Xipere, which Arctic markets as Arcatus or ARVN001, in Greater China, South Korea, Australia, New Zealand, India, and the Association of Southeast Asian Nations’ countries.

OKYO Pharma says it anticipates completing enrollment of the 48-patient trial of OK-101 for treatment of neuropathic corneal pain by the end of 2Q 2025, and releasing top-line data on the Phase 2a trial in 4Q 2025. The company says it also plans to meet with the Food and Drug Administration on moving forward with clinical plans for OK-101 to treat dry eye disease.

Ophthalmic laser manufacturer Norlase has announced the commercial launch and Food and Drug Administration 510(k) clearance and CE Mark for Norlase Lynx, the first pattern-scanning laser indirect ophthalmoscope. The laser and pattern module is built into the headset, which eliminates the need for an external laser source. Norlase Lynx also has a wireless user interface and multilingual voice control.

The Therapeutic Goods Administration of Australia granted marketing approval to Syfovre (pegcetacoplan) for every-other-month dosing of adult patients with geographic atrophy (GA) secondary to age-related macular degeneration, Apellis Pharmaceuticals reports. The indication is for patients with intact foveas whose central vision is threatened by GA lesion growth.

EyePoint Pharmaceuticals has reported what it describes as positive six-month results for the ongoing Phase II VERONA clinical trial evaluating Duravyu, the vorolanib intravitreal insert using the bioerodible Durasert E implant. The clinical trial met its primary endpoint with extended time to first supplemental injection compared to aflibercept control for the two Duravyu doses evaluated. The trial also demonstrated clinically meaningful outcomes including continued safety with no treatment-related ocular or systemic serious adverse events, according to EyePoint. Duravyu 2.7mg demonstrated a +7.1 letter gain in best-corrected visual acuity and 76-micron reduction in central subfield thickness of the retina at week 24. The supplement-free rate was 73% versus 50% for eyes treated with aflibercept.

Clinical-stage biotechnology company Qlaris Bio has reported what it terms positive topline results from two US Phase II clinical trials, Osprey and Apteryx,  evaluating QLS-111 in patients with primary open angle glaucoma and ocular hypertension. Osprey demonstrated that the 0.015% concentration of QLS-111 dosed once daily in the evening drove the greatest decrease in intraocular pressure (IOP), highlighted by mean reductions of 3.7 mmHg from mean diurnal baseline IOP of 23 mm Hg. The Apteryx study, which is evaluating QLS‑111 0.015% as an additive to latanoprost compared to latanoprost alone, showed combined QLS-111-latanoprost dosing achieved significantly greater reductions in IOL than the comparator.

4D Molecular Therapeutics says it is planning a corporate webcast on Monday, February 10, to discuss interim 52-week results from the Phase IIb population extension cohort of the PRISM clinical trial, evaluating 4D-150 in wet age-related macular degeneration patients. The data will be presented at the Angiogenesis, Exudation, and Degeneration 2025 conference this weekend.

In Japan, Astellas Pharma, which makes another treatment for geographic atrophy, Izervay (avacincaptad pegol), reports it submitted a New Drug Application to the Ministry of Health, Labor, and Welfare for conditional approval. If approved, Izervay could become the first and only GA treatment available in Japan.

The following trial readouts were reported last weekend at the virtual Angiogenesis, Exudation, and Degeneration 2025 meeting hosted by Bascom Palmer Eye Institute of the Miller School of Medicine at the University of Miami.

Results from two subgroup analyses from the Phase IIb ODYSSEY clinical trial of CLS-AX, a suprachoroidal injection platform for the tyrosine kinase inhibitor axitinib, in patients with neovascular age-related macular degeneration (nAMD), provided clarity on clinical trials going forward, trial sponsor Clearside Biomedical reported. The first subgroup analysis supports enrolling treatment-naive patients in the planned Phase III program. The analysis showed stabilization of both the best corrected visual acuity (BCVA) and central subfield thickness (CST) in participants redosed with CLS-AX at Week 24 who did not require aflibercept rescue or CLS-AX redosing before that. The second subgroup analysis supports excluding participants prior to randomization in the Phase III trial who demonstrated significant non-disease–related changes in visual acuity.

Regeneron Pharmaceuticals announced the first readout from the Phase III QUASAR trial evaluating Eylea HD (aflibercept 8 mg) for macular edema following retinal vein occlusion. The trial met its primary endpoint at 36 weeks, with both groups of Eylea HD patients dosed every eight weeks achieving noninferior visual acuity gains compared to those receiving Eylea (aflibercept 2 mg) dosed every four weeks. The EYLEA HD results were consistent across patients with branch retinal vein occlusions and those with central retinal or hemiretinal vein occlusions. Eighty-eight percent of patients were able to sustain an eight-week dosing regimen following three initial monthly doses, and 93% stayed on eight-week dosing after completing five initial monthly doses. Safety outcomes between Eylea HD and Eylea were also similar, with the rate of intraocular inflammation 0.5% and 1.3% for the respective treatments.

Regeneron also disclosed three-year outcomes of the Phase III PULSAR trial of Eylea HD to treat nAMD. The data demonstrated that nearly 60% of patients had a last assigned dosing interval of four months or more, with 40% and 24% having a last assigned dosing interval surpassing five and six months, respectively. Vision gains and anatomical improvements achieved through year two were also sustained through year three in the extension study, Regeneron reported.

4D Molecular Therapeutics reported initial interim 52-week data from the Phase IIb population extension cohort of the PRISM clinical trial evaluating 4D-150 in a broad nAMD population. The 4D-150 treated patients had an 83% reduction in supplemental 2-mg aflibercept injections, representing 0.97 mean supplemental injections per patient over a year vs. six injections projected with on-label aflibercept 2 mg every eight weeks. Seventy percent of 4D-150 patients needed one injection or fewer, and 57% were injection free. The 4D-150 patients also demonstrated improved and maintained BCVA of +2.2 letters and had durable CST improvement. The findings also showed 4D-150 was well tolerated during up to three years of follow-up in all patients treated with 3E10 vector genes per eye dose.

Bayer, which holds the European franchise for Eylea (aflibercept), has submitted an application to the European Medicines Agency to expand treatment intervals of up to six months with Eylea HD, the 8-mg formulation, for the treatment of neovascular  age-related macular degeneration (nAMD) and diabetic macular edema (DME). The submission is based on three-year results from open-label extension studies of the clinical trials PULSAR in nAMD, and PHOTON in DME, in which 24% of treated patients in the former and 28% in the latter achieved a last assigned dosing interval of six months at the end of three years.

Meanwhile, the same European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for Pavblu, Amgen’s biosimilar that references aflibercept 2 mg. Known as Pavblu in the US, the biosimilar will be marketed as Skojoy in a variety of European countries.

OK-101, Okyo Pharma’s lead asset, has been officially assigned the US Adopted Name (USAN) urcosimod. Okyo explains that the suffix “-mod” denotes its classification as a modulator of key inflammatory and neuropathic pathways, important pathways in neuropathic corneal pain (NCP) and dry eye disease (DED), two indications for which Okyo is pursuing development of the agent. The USAN program, jointly managed by the American Medical Association, the US Pharmacopeial Convention, and the American Pharmacists Association, assigns unique nonproprietary names to pharmaceutical substances to ensure clarity in medical communication.

Opthea has completed the final week 52patient visit in COAST, the first of two Phase III pivotal trials evaluating the sozinibercept in combination with aflibercept (COAST) or ranibizumab (ShORe) compared to standard of care alone for the treatment of wet age-related macular degeneration. Opthea says it anticipates topline results from both trials this year.

The first pediatric patient has been dosed in the ongoing Phase I/II clinical trial evaluating OPGx-LCA5, the investigational gene therapy for the treatment of Leber congenital amaurosis (LCA), Opus Genetics reports. Opus plans to share initial data from the pediatric cohort by Q3. Opus says it now plans to share the new 12-month data on these three adult LCA5 patients in Q2. An FDA Type D meeting is scheduled in March to discuss the pivotal trial design and endpoints.

Ocugen says it has completed dosing ahead of schedule in the Phase II portion of the Phase I/II ArMaDa clinical trial for OCU410, a multifunctional modifier gene therapy candidate being developed for the treatment of geographic atrophy secondary to dry age-related macular degeneration. The trial has randomized 51 patients to single subretinal medium- (200-µL 5 x 10¹⁰ vector genomes [vg]/mL) or high-dose (1.5 x 10¹¹vg/mL) treatment arms and a control arm.

The Food and Drug Administration approved expanded US Prescribing information for Izervay (avacincaptad pegol) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). It means that Izervay is now approved without a limitation on duration of dosing. The approval follows Astellas Pharmaceuticals’ resubmission of the supplemental New Drug Application last year. The application was was based on positive results from the Phase III GATHER 2 clinical trial, which evaluated Izervay through two years. The FDA first approved Izervay in 2023 for the treatment of GA secondary to AMD.

The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to RPESC-RPE-4W transplantation for the treatment of dry age-related macular degeneration, Luxa Biotechnology reports. RPESC-RPE-4W is a cell product derived from adult retinal pigment epithelial stem cells (RPESC). Transplantation of progenitor-stage RPESC-retinal pigment epithelial cells (RPE) obtained after four weeks of differentiation have been shown to replace the native RPE cells lost during AMD disease progression. The RPESC program is currently in a Phase I/IIa clinical trial.

The Food and Drug Administration granted 510(k) clearance of the VIA360 Surgical System, designed to deliver controlled amounts of viscoelas­tic fluid during ophthalmic surgeries and excise trabecular meshwork tissue during trabeculotomy procedures, ophthalmic surgical device maker New World Medical reports.

Opus Genetics has completed enrollment in the VEGA-3 Phase III clinical trial evaluating phentolamine ophthalmic solution 0.75% for presbyopia, and announced that enrollment in the LYNX-2 pivotal Phase III trial of phentolamine for the treatment of visual loss in low light conditions associated with keratorefractive surgery, is underway. Opus says it expects to complete enrollment in the latter in the first half of the year.

Meanwhile, the Food and Drug Administration has granted phentolamine Fast Track designation as treatment of significant chronic night driving impairment with concomitant increased risk of motor vehicle accidents and debilitating loss of best spectacle corrected mesopic vision in keratorefractive patients with glares, halos, or starbursts and similar stigmata.
Cognition Therapeutics has reported a positive outcome of an analysis of masked data from the ongoing MAGNIFY Phase II trial of zervimesine, also known as CT1812, in adults with geographic atrophy secondary to dry age-related macular degeneration. Results from the first 57 participants who completed at least six months of dosing showed that zervimesine-treated patients were experiencing a slower lesion growth rate than those on placebo. MAGNIFY has enrolled 100 patients to date.

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Glaukos Corp.  says it has received the “Day 74” notification from the Food and Drug Administration acknowledging the previously submitted New Drug Application for Epioxa (Epi-on) is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act goal date is set for October 20, 2025. Epioxa is Glaukos’ next-generation corneal cross-linking therapy for the treatment of keratoconus, a sight-threatening corneal disease.

Formycon AG and licensing partner Klinge Biopharma report that the UK Medicines and Healthcare products Regulatory Agency has approved FYB203 (aflibercept 2 mg), a biosimilar to Eylea under the brand name Ahzantive. Approved indications are neovascular age-related macular degeneration, diabetic macular edema, visual impairment due to myopic choroidal neovascularization, and macular edema following retinal vein occlusion. The US Food and Drug Administration granted marketing authorization for FYB203 in June 2024, followed by the European Commission in January this year.

Formycon and Teva Pharmaceuticals also recently announced a partnership for the semi-exclusive commercialization of FYB203 across major parts of Europe, including the United Kingdom, as well as Israel. Concurrently, Formycon concluded an agreement with Teva for product supply. Teva is already marketing Formycon’s FYB201 ranibizumab biosimilar (Ongavia) in the UK.

In the US, Teva and partner Alvotech report the Food and Drug Administration has accepted their Biologic License Application for another Eylea biosimilar, AVT06. They say they expect to complete the process for regulatory approval by Q4. Alvotech is currently also working on AVT29, a biosimilar candidate to Eylea HD (aflibercept 8 mg), for which Teva holds US commercialization rights.

The Food and Drug Administration has granted 510(k) clearance for the VIA360 Surgical System, reports New World Medical. VIA360 is designed to deliver controlled amounts of viscoelastic fluid during ophthalmic surgeries as well as to excise trabecular meshwork tissue during trabeculotomy procedures. Proprietary ActiveInject technology enables on-demand viscoelastic delivery independent of catheter movement, and the Smart Prime System is designed to optimize viscoelastic volume. The system also has a rotatable cannula that does not require full device rotation.

Health Canada has granted Bayer marketing authorization for Eylea HD (aflibercept 8mg/0.07mL), a new prefilled syringe with integrated dosing system. Bayer has licensed the exclusive marketing rights for Eylea HD outside the US.

Adverum Biotechnologies has announced the initiation of the ARTEMIS Phase III study of Ixo-vec (ixoberogene soroparvovec) as a one-time intravitreal injection for patients with neovascular age-related macular degeneration (AMD). ARTEMIS is a US-based study evaluating a single administration of Ixo-vec (6E10 vg/eye), compared to aflibercept (2 mg) every eight weeks in approximately 300 patients with wet AMD. It’s the first of two planned Phase III registrational trials to evaluate Ixo-vec in wet AMD. The second study, named AQUARIUS, will be conducted globally.

Data from the Phase IIb trial of sozinibercept have been published in the journal Ophthalmic Surgery, Lasers and Imaging Retina, trial sponsor Opthea reports. The paper reports prespecified and post hoc analyses of angiographic predictors of response to sozinibercept combination therapy with ranibizumab in treatment-naive patients with wet age-related macular degeneration (AMD). The prespecified subgroup analyses showed that in patients with occult and minimally classic lesions excluding retinal angiomatous proliferation, which represented 73% of the study population, sozinibercept combination therapy demonstrated a statistically significant additional 5.7-letter average gain in best corrected visual acuity compared to ranibizumab alone. A greater proportion of patients in this subgroup also gained 15 or more letters and had improved anatomy of better drying of the retina with reduced choroidal neovascularization area at week 24 compared to ranibizumab alone.

Cognition Therapeutics reports the publication of work supporting the potential of zervimesine (CT1812), a small-molecule drug candidate to treat dry age-related macular degeneration (AMD) in the Journal of Nature Scientific Reports. The paper reviewed three separate studies: an analysis of cerebrospinal fluid (CSF) collected from participants of two Alzheimer’s disease clinical trials to identify the impact of zervimesine treatment on disease-relevant proteins; a separate analysis of these CSF samples to identify pathways associated with dry AMD that were altered by treatment with zervimesine; and an in vitro study to investigate zervimesine’s ability to rescue important cellular processes in a cell model of dry AMD.

Belite Bio reports that its Data Safety Monitoring Board has recommended the pivotal global Phase III DRAGON trial data of Tinlarebant in adolescent patients with Stargardt disease proceed without any modifications. The Board based its recommendation on an interim analysis of results after all subjects completed the one-year assessment.

The Food and Drug Administration has granted approval of Encelto (revakinagene taroretcel-lwey) for the treatment of macular telangiectasia type 2 (MacTel), Neurotech Pharmaceuticals has announced. MacTel is a neurodegenerative retinal disease in adults that causes progressive and irreversible vision loss. Encelto utilizes an encapsulated cell therapy technology designed to continually deliver therapeutic doses of ciliary neurotrophic factor to the retina to assist in slowing disease progression. The approval was based on results from two Phase III trials that demonstrated that after placement, of the implant, Encelto significantly slowed the loss of macular photoreceptors in MacTel patients over 24 months. Neurotech says it expects Encelto to be available in the US starting in June.

Avirmax Biopharma reports it has commenced the Investigational New Drug–enabling studies of ABI-201, a potential first-in-class adeno-associated virus vector gene therapy for retinal disease. ABI-201 is constructed to achieve durable expression of three transgenes in the eye after a single intravitreal injection.

Luxa Biotechnology has reported data from the Phase I/IIa clinical trial evaluating RPESC-RPE-4W, a proprietary retinal pigment epithelium stem cell therapy for patients with dry age-related macular degeneration. The data, reported at the 77th Annual Wills Eye Conference in Philadelphia, showed that patients in one group had an average gain of +21.67 letters at 12 months while the second group had a +3.3-letter improvement at three months. The data are based on six patients in the first low-dose cohort.

The first patients have been enrolled across multiple sites in the 4FRONT-1 Phase III clinical trial evaluating 4D-150 for the treatment of neovascular age-related macular degeneration (nAMD), trial sponsor 4D Molecular Therapeutics reports. 4FRONT-1 is evaluating 4D-150 alongside the comparator aflibercept 2 mg every eight weeks. The primary endpoint is noninferiority in the mean change from baseline in best corrected visual acuity at 52 weeks. A second Phase III trial of 4D-150 for nAMD, 4FRONT-2, has an identical design to 4FRONT-1, but will enroll treatment-naive and recently diagnosed, treatment-experienced nAMD patients globally. 4FRONT-2 is expected to start in Q3 2025. Topline primary endpoint data from both trials is expected in the second half of 2027.

Sydnexis reports that Food and Drug Administration has accepted its New Drug Application (NDA) for SYD-101 and has assigned a Prescription Drug User Fee Act target action date of October 23. If approved, SYD-101 would be the first treatment for progression of pediatric myopia in the United States. The NDA is based on three-year primary and secondary endpoints from the STAR Study, Sydnexis’ pivotal Phase III clinical trial evaluating this proprietary, low-dose atropine formulation to slow the progression of pediatric myopia and the risk of associated comorbidities.

Clinical-stage gene therapy company Atsena Therapeutics has obtained FDA Fast Track designation for ATSN-201 for the treatment of X-linked retinoschisis. ATSN-201, a gene therapy candidate, uses AAV.SPR, the company’s novel spreading capsid, to achieve therapeutic levels of gene expression in photoreceptors of the central retina while avoiding the surgical risks of foveal detachment.

Neurotech Pharmaceuticals, a private biotech company, reports that FDA has approved Encelto (revakinagene taroretcel-lwey) for the treatment of macular telangiectasia type 2 (MacTel), a neurodegenerative disease of the retina in adults that causes progressive and irreversible vision loss. Encelto uses an encapsulated cell therapy technology designed to continually deliver therapeutic doses of ciliary neurotrophic factor to the retina to assist in slowing the progression of the disease. Neurotech says it expects Encelto to be available in the US in June.

OKYO Pharma has submitted to the FDA an application for Fast Track designation for urcosimod, formerly known as OK-101, for the treatment of neuropathic corneal pain. Urcosimod is a lipid-conjugated chemerin peptide agonist of the protein-coupled receptor typically found on the eye’s inflammatory immune cells. It would be the first FDA-approved therapy for neuropathic corneal pain.

Clearside Biomedical says it has had what it calls a “positive” end-of-Phase II meeting with the FDA regarding CLS-AX (axitinib injectable suspension) for the treatment of neovascular age-related macular degeneration. Axitinib is a tyrosine kinase inhibitor that, in CLS-AX, is administered in a suprachoroidal injection using Clearside’s SCS Microinjector.

Iantrek Corp., a venture-backed ophthalmic technology company, reports the publication of two-year results in the journal Ophthalmology Science from its prospective clinical study evaluating its proprietary bioreinforced cyclodialysis technology. The results demonstrate the long-term efficacy and safety of the biointerventional platform to improve uveoscleral outflow enhancement for people with open-angle glaucoma undergoing concurrent cataract surgery. Among the key findings are that 74% of treated eyes achieved a 20% or greater reduction in intraocular pressure (IOP) at two years with the same number or fewer glaucoma medications, and an average medicated IOP reduced of 34%.

Stealth BioTherapeutics reports that enrollment in the global Phase III ReNEW study of elamipretide in patients with dry age-related macular degeneration (AMD) has reached its halfway mark. The total target enrollment is 360 participants. The ReNEW study is evaluating the efficacy, safety, and pharmacokinetics of daily subcutaneous injections of elamipretide, a mitochondria-targeted investigational drug.

Australia-based Opthea Limited is scrambling to figure out its next steps after the Phase III clinical trial of sozinibercept, its lead candidate for the treatment of neovascular age-related macular degeneration failed to meet its primary endpoint of mean change in best corrected visual acuity (BCVA) from baseline to week 52. The trial evaluated intravitreal sozinibercept 2 mg every four or eight weeks in combination with aflibercept 2 mg every eight weeks versus aflibercept only every eight weeks after loading doses. The aflibercept-only arm had slightly superior results in BCVA change than the sozinibercept-aflibercept combination arm, but the differences were not statistically significant. The future for Opthea is uncertain, according to reports. PharmaPhorum reported the readout “puts Opthea at risk of insolvency.” “Opthea’s future unclear,” stated The Pharma Letter. The news website The Australian noted, “Opthea solvency in question as trial failure trips $1 billion (Australian) trigger.”

The Centers for Medicare & Medicaid Services (CMS) has approved Harrow’s transitional pass-through application for Triesence (triamcinolone acetonide injectable suspension) 40 mg/mL, a preservative-free synthetic corticosteroid approved for visualization during vitrectomy and for the treatment of ocular inflammatory conditions that do not respond to topical corticosteroids. Beginning April 1 and for the three years thereafter, Triesence will be eligible for separate reimbursement outside of the surgical bundled payment in both the ambulatory surgery center and hospital outpatient department. CMS will now separately reimburse Triesence at the average sales price plus 6% in both surgical settings.

The ranibizumab biosimilar Ongavia (Bioeq/Teva Pharmaceuticals) failed to achieve equal outcomes to aflibercept (Eylea, Regeneron Pharmaceuticals), according to results of a retrospective study reported in the journal Cureus. The single-center study of 62 eyes found that eyes treated with Eylea had significantly greater improvement in best-corrected visual acuity and central retinal thickness compared to Ongavia. Ranibizumab is distributed under the trade name Lucentis (Genentech/Roche).

Opus Genetics has reported one-month clinical data from the first pediatric patient treated with its investigational gene therapy, OPGx-LCA5, in a Phase I/II open-label trial for Leber congenital amaurosis-5 (LCA5)-related inherited retinal disease. The new data builds upon previously reported positive results from adult patients treated in the same study. The first pediatric participant, aged 16 at the time of consent, received a single subretinal injection of OPGx-LCA5 and has demonstrated clinically meaningful improvement in vision at one-month post-treatment with no observed drug-related adverse events so far. Opus says it expects to deliver a readout of efficacy data for all three pediatric patients in Q3. The company says a pivotal trial could start next year depending on discussions between it and the Food and Drug Administration.

The Food and Drug Administration has rejected Aldeyra Therapeutics’ resubmitted New Drug Application (NDA) for reproxalap, a candidate for the treatment of dry eye disease. The FDA issued a Complete Response Letter notifying the company that the NDA “failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes” and stated that at least one more study should be conducted to demonstrate its efficacy. Aldeyra says it intends to resubmit the NDA midyear, provided ongoing discussions with the FDA are positive. The company says the review period for the potential NDA resubmission is expected to be six months.

Bayer, which holds the franchise for Eylea (aflibercept) outside the US, has submitted an application to the European Medicines Agency seeking approval of Eylea HD (aflibercept 8 mg) for the treatment of patients with macular edema following retinal vein occlusion, including central, branch, and hemiretinal vein occlusion. This would be the third indication for Eylea HD in the European Union, First Word Pharma reports.

Outlook Therapeutics reports that the Food and Drug Administration has acknowledged receipt of its resubmitted Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of neovascular age-related macular degeneration (AMD). The FDA has determined that the BLA is a Class 2 review, which results in a six-month review period from the date of resubmission. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 27. ONS-5010, if approved, will be branded as Lytenava in the US. Outlook says it expects to receive 12 years of regulatory exclusivity. ONS-5010 is already approved in the European Union and the United Kingdom for the treatment nAMD.

Tenpoint Therapeutics has submitted a New Drug Application to the Food and Drug Administration for Brimochol PF for the treatment of presbyopia. If approved, the formulation would be the first combination therapy for presbyopia. The application is supported by data from the first pivotal Phase III BRIO-I study, which demonstrated the benefit of the combination therapy over the individual components.

Oculis Holding reports it has completed enrollment in both Phase III trials, DIAMOND-1 and DIAMOND-2, of OCS-01 eye drops in diabetic macular edema. The multinational trials have enrolled more than 800 patients at 119 sites. Topline data from both Phase III trials are expected in Q2 2026.

Atsena Therapeutics reports that the Food and Drug Administration has granted Regenerative Medicine Advanced Therapy designation for ATSN-201 for the treatment of X-linked retinoschisis. ATSN-201 is a gene therapy candidate that uses AAV.SPR, the company’s novel spreading capsid, to achieve therapeutic levels of gene expression in photoreceptors of the central retina while avoiding the surgical risks of foveal detachment.

A new study reports that home-based optical coherence tomography (OCT) could potentially save the healthcare system more than $1 billion by avoiding early treatments for neovascular age-related macular degeneration (nAMD). The study, published in the Journal of VitreoRetinal Diseases, is the first to demonstrate changes in physician decision-making due to the availability of home OCT data. In more than 42% of cases, physicians decided they would not treat the patient when they were treated in real life. In 61% of the remaining cases, when physicians did decide to treat, they would have brought the patients in a week or more earlier. The study was funded by Notal Vision, developer and distributor of the ForseeHome AMD Monitoring Program.

The Food and Drug Administration has issued a complete response letter to Regeneron Pharmaceuticals’ supplemental Biologics License Application (sBLA) in which it did not agree with adding extended dosing intervals beyond every 16 weeks for Eylea HD (aflibercept 8 mg injection) across all approved indications. Regeneron filed the sBLA seeking dosing intervals of up to every 24 weeks. Regeneron says it is evaluating the FDA’s decision and will determine a path forward in due course. Eylea HD is currently approved with dosing intervals from every eight to 16 weeks for patients with wet age-related macular degeneration and diabetic macular edema, and every eight to 12 weeks for patients with diabetic retinopathy, following three initial monthly doses.

BVI Medical has received 510(k) clearance from the FDA for the Leos (Laser Endoscopy Ophthalmic System) glaucoma surgical system. The laser system lowers intraocular pressure by addressing aqueous humor production in a minimally invasive ab interno procedure. The company says “broad commercialization” is planned this year.

The FDA has cleared Luminopia’s amblyopia treatment for patients aged 8 to 12 years, expanding its existing label from patients 4 to 7 years old to patients 4 to 13 years old with amblyopia associated with anisometropia and/or mild strabismus, the company reports. The treatment consists of binocular therapy using a virtual reality headset.

SpyGlass Pharma reports that 18-month data from the first-in-human study of its Drug Delivery Platform demonstrated improvements in both visual acuity and intraocular pressure (IOP) outcomes, key objectives for long-term treatment of glaucoma or ocular hypertension. The data were presented in a poster at the American Society of Cataract and Refractive Surgery Annual Meeting. The single-center, prospective, cohort study included 23 patients with a visually significant cataract and concomitant glaucoma or ocular hypertension. All patients received the SpyGlass Intraocular Lens–based drug delivery platform at the time of cataract surgery. Results showed that best-corrected distance visual acuity improved from 20/30-20/100 at baseline to 20/16-20/30 at 18 months. Mean IOP was significantly reduced from 25.1 (± 2.5) mmHg at baseline post-washout to 14.1 (± 2.6) mmHg at 18 months (P < 0.0001). All patients remained off all topical IOP-lowering medications. There was no statistically significant difference in IOP reduction across the three dosage groups tested, and no product-related adverse events were observed in the study.

Galimedix Therapeutics reports completion of the single ascending-dose part of the Phase I study of oral GAL-101, a small-molecule specifically designed to target misfolded amyloid beta monomers in Alzheimer’s disease, dry age-related macular degeneration (AMD), and glaucoma. The results showed that GAL-101 was well tolerated with a favorable safety profile, Galimedix reports. Galimedix also is conducting a Phase II trial with GAL-101 eyedrops for dry AMD.

The following trial readouts were reported at Association for Research in Vision and Ophthalmology (ARVO 2025) Annual Meeting.

• Biopharmaceutical company Perfuse Therapeutics has reported 24-week results from its completed Phase I/IIa trial of PER-001, an endothelin antagonist intravitreal implant for glaucoma. The results demonstrated clinically meaningful increases in optic nerve head blood flow, and improved vision.

• Isarna Therapeutics presented final results from its Phase II BETTER trial of ISTH0036, a selective TGF-β2-blocking antisense oligonucleotide, in patients with neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Patients who received intravitreal injections of ISTH0036 every eight weeks had stable or improved best-corrected visual acuity, along with anatomical improvements in the retina.

• Opus Genetics announced one-year results from adults treated in the Phase I/II trial of OPGx-LCA5, its lead gene therapy candidate for treatment of Leber congenital amaurosis 5, a potentially blinding inherited retinal degeneration. Preliminary data showed gains in cone-mediated vision at one year. The results were from three adult patients (aged 19 to 34 years old), all of whom received subretinal injections in a single eye of up to 300 µl of low-dose (1x1010 vector genome per eye) OPGx-LCA5. Among outcomes, visual acuity improvements were equivalent to a 3.5-line gain across the three participants. Two additional adolescent patients have now also been treated.

• Beacon Therapeutics reported six-month interim safety and efficacy results from the Phase II DAWN trial of its lead program, laru-zova (laruparetigene zovaparvovec), in patients with X-linked retinitis pigmentosa, an inherited retinal disease often caused by mutations to the RPGR gene. The data showed nonserious ocular treatment-emergent adverse events, early improvements in low-luminance visual acuity, and early and sustained improvements in mean sensitivity in study eyes, as observed by microperimetry.

The Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to the following two companies and candidates:

• 4D Molecular Therapeutics’ 4D-150 for the treatment of diabetic macular edema. 4D-150 is a potential backbone therapy that is designed to provide multiyear sustained delivery of the anti–vascular endothelial growth factor (VEGF) aflibercept and anti-VEGF-C from the retina with a single intravitreal injection. 4D-150 is also being developed for neovascular age-related macular degeneration.

• Opus Genetics’ OPGx-LCA5, its investigational gene therapy for Leber congenital amaurosis (LCA) due to genetic variations in the LCA5 gene. Opus has also been invited to participate in the FDA’s Initial Comprehensive Multidisciplinary RMAT Meeting to support Opus’ development and manufacturing strategy. Lastly, Opus has been invited to join the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot program, which provides additional guidance for accelerating product development under an investigational new drug application.

RMAT designation was created in the 21st Century Cures Act to expedite review of regenerative medicine therapies.

The Food and Drug Administration granted Fast Track designation to urcosimod, formerly called OK-101, OKYO Pharma’s drug candidate for the treatment of neuropathic corneal pain.

The following trial readouts were reported at the Association for Research in Vision and Ophthalmology (ARVO 2025) Annual Meeting.

• Data from the first independent validation of the recently published Collaborative Ocular Oncology Group Study No. 2 support adding preferentially expressed antigen in melanoma (PRAME) gene expression information to the DecisionDx-UM test result to further refine metastatic risk prediction for patients with uveal melanoma, trial sponsor Castle Biosciences reports.

• NurExone Biologic reports that its preclinical data on optic nerve regeneration demonstrated that ExoPTEN restored retinal activity and improved optic nerve structure in a controlled rat model of optic nerve compression.

• Topline results from the LIGHTSITE IIIB extension trial of the Valeda Light Delivery System demonstrated an improvement of vision of more than one line in more than 60% of the subjects from two studies, trial sponsor LumiThera reports. Valeda is a photobiomodulation treatment for patients with dry age-related macular degeneration.

Topline results from the Phase II COG2201 MAGNIFY trial of zervimesine (CT1812) in adults with geographic atrophy (GA) secondary to dry age-related macular degeneration showed treated patients had 28.6% slower GA lesion growth on average, and at 18 months their lesions were 28.2% smaller compared to placebo, sponsor Cognition Therapeutics reports. The MAGNIFY study was concluded, after approximately 100 of the planned 246 participants were enrolled. Approximately two-thirds of patients completed 12 months of dosing and one-third completed 18 months of dosing. Cognition says it will report additional data, including safety, demographics, and visual and anatomic outcomes, later this year.

Clinical-stage gene therapy company Atsena Therapeutics has reported positive clinical data from Part A of the LIGHTHOUSE study, a Phase I/II clinical trial evaluating subretinal injection of ATSN-201 for the treatment of X-linked retinoschisis (XLRS). ATSN-201 leverages AAV.SPR, the company’s novel spreading capsid, to achieve therapeutic levels of gene expression in photoreceptors of the central retina while avoiding the surgical risks of foveal detachment. The candidate has received Regenerative Medicine Advanced Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug designations from the Food and Drug Administration.

Part A of the study evaluated the tolerability and safety of three different doses of ATSN-201 administered through subretinal injection in three patients per cohort, for a total of nine adult patients. ATSN-201 was well-tolerated in all nine patients with XLRS in Part A, with no serious adverse treatment-related events. The preliminary evidence of efficacy was demonstrated at all dose levels. On microperimetry, 67% of treated eyes had an improvement of ≥ 7 decibels in the five or more loci with the lowest sensitivity at baseline

EyePoint Pharmaceuticals reports it has enrolled and randomized more than 400 patients in the Phase III LUGANO pivotal trial of Duravyu for the treatment of neovascular age-related macular degeneration exceeding its enrollment target. LUGANO is the first of two pivotal non-inferiority trials underway in the Phase III program of Duravyu. EyePoint says topline data from LUGANO is expected in mid-2026.

Topline data from the Phase II trial of ILYX-002, a topical immunomodulator for moderate-to-severe dry eye disease (DED) associated with systemic autoimmune or inflammatory conditions, demonstrated a meaningful clinical improvement in ocular surface health, trial sponsor Iolyx Therapeutics reports. The results demonstrated a 36% to 44% improvement from baseline in total corneal fluorescein staining, a biomarker of corneal epithelial health, in treated patients versus a 15% to 17% improvement in controls.

Ocular Therapeutix is closing enrollment in the SOL-R registrational trial of Axpaxli in neovascular age-related macular degeneration. Ocular says the decision is based on results of SOL-R to date. The trial has randomized at least 555 patients in the US, Argentina, India, and Australia. The trial is evaluating the safety and efficacy of Axpaxli dosed every six months versus aflibercept 2 mg every eight weeks. The trial is 90% powered to detect a noninferiority margin of –4.5 letters of mean best-corrected visual acuity when compared to aflibercept.

Selagine, a spin-out company from the University of Illinois, Chicago, and strategic partner Grifols received Food and Drug Administration Investigational New Drug (IND) clearance for a Phase II trial for GRF312 ophthalmic solution, a topical immunoglobulin drop indicated for the treatment of dry eye disease. The drop is an anti-inflammatory and immunomodulatory biologic drug that is generated from pooled human plasma. The IND grew out of a research, development, and sublicense agreement between Selagine and Grifols.

Ocugen has received Rare Pediatric Disease Designation from the Food and Drug Administration for OCU410ST, its gene therapy treatment for ABCA4-associated retinopathies, including Stargardt disease. The candidate already holds Orphan Drug designations from both the FDA and European Medicines Agency. If the Priority Review Voucher program is reauthorized, Ocugen could receive a voucher worth approximately $100 million. The company says it plans to begin Phase II/III pivotal confirmatory trials soon, targeting a Biologics License Application filing in 2027.

Genentech/Roche has received Food and Drug Administration approval for Susvimo (ranibizumab) 100 mg/mL port delivery system for the treatment of diabetic retinopathy.

The FDA has granted the clinical-stage biopharmaceutical company Belite Bio Breakthrough Therapy Designation for Tinlarebant for the treatment of Stargardt disease. The designation is based on interim data from the ongoing Phase III DRAGON trial.

German pharmaceutical giant Bayer, which holds the ex-US franchise for Eylea, has received a recommendation from the European Medicines Agency (EMA) to extend dosing intervals for Eylea HD (aflibercept 8 mg). The EMA backed the use of an 8 mg dose administered every six months for treating neovascular age-related macular degeneration (nAMD) and diabetic macular edema. Bayer also received approval from the Center for Drug Evaluation of China’s National Medical Products Administration for Eylea HD to treat nAMD .

Iolyx Therapeutics has reported topline data from the Phase II trial of ILYX-002, a topical immunomodulator for moderate-to-severe dry eye disease associated with systemic autoimmune or inflammatory conditions. The study met significance for both staining endpoints at day 15. ILYX-002 produced a –1.41 -point LS -mean advantage versus the vehicle control in total corneal fluorescein staining as early as day 15, increasing to –1.78 points at day 57. Corneal staining is a key biomarker of dry eye pathology. The results indicate a 36%-to-44% improvement from baseline in the active arm versus 15%-to-17% in the control group.

Opus Genetics has reported what it describes as positive topline results from LYNX-2, a pivotal Phase III clinical trial evaluating phentolamine ophthalmic solution 0.75% for the treatment of significant, chronic night driving impairment in keratorefractive patients with reduced mesopic vision. The study met its primary endpoint of a gain of three lines (15 letters) or more of distance vision improvement on a low–contrast chart in low–light conditions after 15 days of dosing. In the study, 17.3% of patients treated with phentolamine achieved a greater than 15-letter Early Treatment Diabetic Retinopathy Study (≥ 3-line) improvement in mesopic low–contrast distance visual acuity at day 15, compared to 9.2% in the placebo group.

The Food and Drug Administration has approved Alcon’s Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for dry eye disease. Tryptyr is a TRPM8 receptor agonist that stimulates corneal sensory nerves to increase natural tear production.

The FDA has accepted Tenpoint Therapeutics’ New Drug Application for Brimochol for the treatment of presbyopia. The FDA has set a Prescription Drug User Fee Act date of January 28, 2026. The FDA stated that it is not planning to hold an advisory committee meeting to discuss the application.