As we look back at the past year, the ophthalmic space has seen some exciting innovations in pharmaceuticals and delivery systems along with witnessing some unfortunate developments surrounding the recall of artificial tears.
With 2023 drawing to a conclusion, here’s a review of FDA updates we covered this year.
FDA drug and delivery approvals
FDA approvals are granted after numerous rounds of research to ensure it is safe for public consumption. There are five steps:
- Discovery/concept
- Preclinical research
- Clinical research
- FDA review
- FDA post-market safety monitoring
Retina
EYLEA (Regeneron Pharmaceuticals) for ROP
Regeneron Pharmaceuticals, Inc. announced FDA approval in February to use EYLEA for the treatment of retinopathy of prematurity (ROP) in preterm infants. Eylea was previously approved to also manage wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema, and diabetic retinopathy.
The intravitreal injection is to be administered six to eight times a year. The medication is designed to inhibit vascular endothelial growth factor (VEGF) by blocking growth factors in ocular angiogenesis, thereby reducing vascular permeability.
IZERVAY (IVERIC bio, An Astellas Company)
IZERVAY from IVERIC Bio, Inc. was FDA approved in August 2023 as an intravitreal injection to treat GA secondary to AMD. The medication (avacincaptad pegol) was designed to block the C5 protein to reduce overactivity within the complement system, possibly slowing GA progression. The approved dosage is a 2mg injection every month for up to 12 months.
SYFOVRE (Apellis Pharmaceuticals)
Apellis Pharmaceuticals received approval for SYFOVRE from Apellis Pharmaceuticals was also approved to treat GA related to AMD in February 2023. This intravitreal injection of pegcetacoplan is administered every 25 to 60 days to reduce GA progression by regulating excessive C3 activity of the complement system.
VABYSMO (Genentech)
Genentech’s VABYSMO—which was previously approved to manage wet AMD and DME—gained FDA approval to treat RVO. It inhibits VEGF and angiopoietin-2 (Ang-2), which are thought to cause vision loss by destabilizing blood vessels. For patients with RVO, a 6mg intravitreal injection is injected every 4 weeks for 6 months.
Presbyopia
VUITY (Allergan)
VUITY from Allergan, an AbbVie company, received FDA approval in March 2023 for twice-daily dosing to treat presbyopia. It was previously approved as a once-daily prescription eye drop and has now been FDA-approved with an additional drop that can be used 3 to 6 hours after the first dose. The therapeutic effect can last up to 9 hours.
QLOSI (Orasis Pharmaceuticals)
Orasis Pharmaceuticals announced that QLOSI, an eye drop for presbyopia, was approved by the FDA in October 2023. This preservative-free, low-dose pilocarpine modulates pupil size to potentially improve near vision. Patients are recommended to use one drop per eye daily, or up to twice a day as needed, lasting up to 8 hours.
MydCombi (Eyenovia, Inc)
Eyenovia, Inc. introduced MydCombi, which was approved by the FDA to induce mydriasis for procedures that require short-term pupil dilation. The ophthalmic spray coats the surface of the cornea at a low velocity, leveraging the company’s proprietary Optejet technology.
RYZUMVI (Ocuphire Pharma, Inc.)
Ocuphire Pharma, Inc. announced FDA approval for RYZUMVI, an eye drop for the reversal of mydriasis (RM). The active ingredient in the medication is phentolamine, which can reversibly bind alpha-1 adrenergic receptors on the iris dilator muscle to reduce pupil diameter. Administration of one to two drops after an ophthalmic exam or procedure will induce RM.
Ocular surface disease
VEVYE (Novaliq GmbH)
VEVYE, an eye drop from Novaliq GmbH, was approved by the FDA to treat dry eye disease (DED). Using EyeSol—Novaliq’s preservative- and water-free technology—and ultrapure semifluorinated alkanes (SFAs), it spreads rapidly over the eye with low surface tension. It can be used twice a day, 12 hours apart.
MIEBO (Bausch + Lomb/Novaliq GmbH)
Bausch + Lomb has taken on exclusive U.S. and Canadian rights from Novaliq to execute the commercialization of MIEBO for the treatment of signs and symptoms of DED, which was approved in May 2023.
The eye drop can prevent tear evaporation by forming a monolayer at the air-liquid interface of the tear film using low surface tension to spread quickly. It can be used up to four times a day.
XDEMVY (Tarsus Pharmaceuticals)
Tarsus Pharmaceuticals, Inc. announced XDEMVY gained FDA approval to treat Demodex blepharitis by eliminating Demodex mite infestation over a 6-week period. It is a topical ophthalmic formulation of lotilaner 0.25%, which is an antiparasitic agent that targets parasite-specific GABA-Cl channels.
Glaucoma
iDose TR (Glaukos Corporation)
Most recently, on December 14, 2023, the FDA approved the iDose travoprost (TR) intraocular implant from Glaukos Corporation. Designed to be implanted during micro-invasive procedures, it has been designed to continuously release medication with the treatment goal of lowering intraocular pressure (IOP) for at least 1 year.
IYUZEH (Thea Pharma Inc.)
After gaining FDA-approved in December 2022 for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT), IYUZEH (latanoprost ophthalmic solution 0.005%) became commercially available in September. IYUZEH, from Thea Pharma Inc, the US subsidiary of Théa Laboratoires, is the first and only clinically-proven formulation of preservative-free latanoprost currently on the US market.
FDA device approvals
FDA approval was given to the first handheld corneal esthesiometer, called the Corneal Esthesiometer Brill (CEB), from Brill Engines, S.L. This portable, manual, and non-invasive device can measure corneal hyperesthesia and hypothesis using controlled pulses of air for the possible early identification of corneal conditions such neurotrophic keratitis (NK), DED, diabetic keratopathy, and more.
The FDA also approved CT LUCIA 621P monofocal intraocular lens (IOL) from ZEISS, which has a hydrophobic acrylic and heparin-coated surface. Using the ZEISS Optic (ZP) Aspherity Concept, it can compensate for varying lens positions and corneal shapes to potentially provide both stability and an enhanced visual experience.
FDA clearances
Medical products that can be equated to a comparable product already on the market with low to moderate risk are classified as Class I or II products. These devices or medications do not require approval and are cleared instead.
TRC-NW400 (Topcon Healthcare)
Topcon’s TRC-NW400 retinal camera was cleared by the FDA in June 2023 to possibly detect diabetic retinopathy (DR). This system uses AI to generate a report of color retinal fundus images in under 60 seconds.
Note: This device is not currently available in the US. It can be purchased in the Asia-Pacific region.
ANTERION (Heidelberg Engineering, Inc.)
Heidelberg Engineering’s ANTERION platform recently gained FDA clearance for its high-resolution visualization of the entire anterior segment. The platform assists with daily clinical workflows using the Imagining App to provide optical coherence tomography (OCT) images.
Investigational new drug (IND) applications
The IND application must be accepted before a drug can be administered to humans during clinical trials and shipped across [US] state lines. Here are some notable IND clearances from this year.
SKG0106 (Skyline Therapeutic)
The FDA cleared Skyline Therapeutics’ IND application for a phase 1/2a clinical trial on SKG0106 to treat neovascular age-related macular degeneration (nAMD). The drug would be delivered via intravitreal injection one time to potentially inhibit intraocular neovascularization using adeno-associated virus (AAV) integrated gene therapy
TOUR006 (Tourmaline Bio, Inc.)
The FDA granted clearance to Tourmaline Bio, Inc. for its IND application for TOUR006 in August 2023. The drug aims to inhibit interleukin-6 (IL-6), a proinflammatory cytokine that may play a key role in the pathogenesis of thyroid eye disease (TED), through low amounts of drug exposure.
EQ-2351 (Endogena Therapeutics, Inc.)
Endogena Therapeutics, Inc. received clearance in October 2023 for its IND application for EQ-2351, which is designed to treat GA. This gene-independent, small-molecule drug targets retinal pigment epithelium (RPE) cells via intravitreal injection to possibly restore dead RPE cells.
2023 Orphan Drug Designations (ODD)
The ODD program allows drugs for the management of rare diseases to receive orphan status when a certain criteria is met, which may provide various financial and marketing advantages.
Trypan Blue and Brilliant Blue G (DORC)
The Dutch Ophthalmic Research Center (DORC) announced that they have received ODD from the FDA for the combination of Trypan Blue (TB) and Brilliant Blue G (BBG) solutions.
When both solutions are injected onto the retinal surface, the solutions can selectively stain the epiretinal membrane (ERM) and internal limiting membrane (ILM) during surgery.
Significant 510(k) clearances
The FDA granted 510(k) clearance to Norlase for its ECHO Green Pattern Laser photocoagulator. The portable device fully integrates both the laser and scanner, and incorporates micro-electromechanical (MEMS) technology. Noted for its affordability, the ECHO allows photocoagulation technology to be more accessible to eyecare providers (ECPs).
The FDA cleared Retitrack from C. Light Technologies, an eye movement diagnostic monitoring system that records retinal video scans to assess tiny movements within the eye. Through 10-second videos of the retina at the photoreceptor level, the device is able to quantify eye motion down to 0.1 degrees and generate a comprehensive report.
CorNeat Vision received 510(k) clearance in June for the EverPatch, a synthetic and non-degradable tissue made out of a non-woven, polymer matrix. This medical device could minimize the need for donor and processed tissue that is often used in ocular surgeries.
The FDA provided 510(k) clearance in September to Altris, Inc. for the Altris Imaging Management System (IMS), which uses artificial intelligence (AI) to provide in-depth analyses of OCT scans. It can detect over 70 retinal conditions and generate a report in 1 minute, according to Altris.
Earlier this month, the FDA granted BELKIN 510(k) clearance for their Eagle device, which is a non-invasive laser designed to perform selective laser trabeculoplasty (SLT) with precision, efficiency, and automation. It is already available in the European Union (EU) and the United Kingdom (UK).
Grants
Rare Pediatric Disease Designations (RPDD)
The FDA grants RPDDs for drugs targeting rare childhood diseases that meet the following criteria:
- Designed to prevent/treat a rare pediatric disease
- Adequate data demonstrating the disease is rare (less than 200,000 individuals in the US)
- Cannot be for a previously approved active ingredient
- Data suggesting the effectiveness of the drug
HG004 (HuidaGene Therapeutics)
HuidaGene Therapeutics received RPDD in August for HG004, a subretinal injection designed to treat RPE65 inherited retinal disease (IRD) mutations. It was previously cleared for an IND application in January 2023 and granted ODD in April 2023.
Recalls
The FDA calls for product recalls when a product is considered to violate FDA regulations. Firms may voluntarily issue a recall, usually following procedures under 21 CFR Part 7 (Enforcement Policy).
In rare cases where recalls are not initiated by firms, the FDA may mandate a recall under 21 CFR Part 810 (Medical Device Recall Authority).
If any medical devices are corrected or removed, manufacturers must report such instances to the FDA under 21 CFR Part 806 (Medical Devices; Reports of Corrections and Removals).
Eye drop recalls
Concerning discoveries regarding many eye drops were made by the FDA throughout 2023 and received considerable attention from patients, doctors, and the media.
Recalls kicked off in February 2023 with the Artificial Eye Ointment from Delsam Pharma, owned by Global Pharma, for possible bacterial contamination. Other products from Global Pharma had received attention a month prior due to multiple reports of infections. By late March 2023, there were a total of three deaths, eight cases of vision loss, and four enucleation procedures relating to these products.
Apotex Corp issued a voluntary recall in March for Brimonidine Tartrate Ophthalmic Solution 0.15% after cracks were discovered in bottle caps. These defects posed sterility concerns with the possibility of leading to adverse events (AE).
Around the same time, Pharmedica USA also voluntarily recalled the Purely Soothing 15% MSM Drops due to non-sterility, which the FDA wrote could lead to infections and possibly blindness.
The FDA warned against the use of two methylsulfonylmethane (MSM) eye drops in August 2023 due to the potential risk of bacterial or fungal contamination. Dr. Berne’s Whole Health Products voluntarily recalled their eye drops soon after the warning.
In October, the FDA warned consumers against using 27 eyedrops—including brands from Target, CVS, Rite Aid, and Walmart—after an FDA inspection of the products’ manufacturing facility revealed unsanitary conditions and positive bacterial test results.
RightEye Vision System (RightEye, LLC)
In late January, RightEye, LLC, was issued a warning letter by the FDA for inaccurately promoting the RightEye Vision System. RightEye claimed that their product could detect and treat vision abnormalities related to a variety of neurological conditions, which it was not cleared to do.
TEPEZZA (Horizon Therapeutics)
In July, the FDA updated the warning label for TEPEZZA from Horizon Therapeutics plc (recently acquired by Amgen), an intravenous infusion therapy for the treatment of thyroid eye disease (TED). Hearing impairment was added as the fourth warning after new research revealed that 20 out of 120 patients reported auditory side effects.
In conclusion
The year 2023 has been exciting and active with eyecare updates and innovations. We’ve seen newly approved products for the management of presbyopia, DED, GA, and much more, in addition to advancing technology incorporated into ophthalmological devices along with novel drug delivery systems.
Stay up-to-date with all of the developments as we report them in 2024!
