With a plethora of FDA approvals popping up across the ophthalmic industry this past year, it’s no surprise we’ve had multitude of commercial product launches as well.
Allow us to catch you up on a few of these ophthalmic additions now available as we head into 2024.
Note: All product names are hyperlinked to their respective Glance coverage.
Where to start?
Kicking off the year was Dr. Reddy’s Laboratories’ therapeutic generic equivalent of Novartis’ Durezol (difluprednate ophthalmic emulsion 0.05%):
Dr. Reddy’s Difluprednate Ophthalmic Emulsion 0.05%
- Launch date: January 2023
- Indication: inflammation and pain associated with ocular surgery and endogenous anterior uveitis
- Recommended dosage:
- For ocular surgery
- One drop instilled into the conjunctival sac of the affected eye, QID, starting 24 hours after surgery and continuing postoperatively for 2 weeks, then for twice a day for 1 week followed by a taper based on response.
- For uveitis
- One drop instilled into the affected eye’s conjunctival sac, QID, for 14 days, then followed by a taper-down regimen dependent on case presentation.
- For ocular surgery
Moving on… let’s talk contact lenses.
We’ve got three major launches for you, with two geared toward presbyopia management:
MyDay Energys contact lenses (stenfilcon A)
- Launch date: February 2023
- Company: CooperVision
- Indication: One-day lenses to address symptoms of discomfort associated with digital eye strain
- Key features:
- Latest addition to CooperVision’s MyDay lens products
- First and only one-day lens to incorporate proprietary single-vision aspheric design and novel technology called DigitalBoost along with enhanced hydration and moisture content to help with eye tiredness and dryness associated with digital eye strain.
INFUSE Multifocal silicone hydrogel (SiHy) contact lenses (kalifilcon A)
- Launch date: June 2023
- Company: Bausch + Lomb
- Indication: Daily disposable lenses for presbyopia management designed to help maintain ocular surface homeostasis to aid in minimizing contact lens dryness
- Key features:
- Next-gen material for high-definition optics with the ability to maintain 96% of its moisture for 16 hours.
- Low modulus to potentially minimize impact on the ocular surface
- 3-Zone Progressive design for a moist / comfortable fit and clear near and intermediate vision without sacrificing on distance vision
TOTAL30 Multifocal contact lenses
- Launch date: October 2023
- Company: Alcon
- Indication: Monthly replacement lenses to target digital device dryness in presbyopia
- Key features:
- Water Gradient Technology creates a cushioning effect where moisture can be nearly 100% water at the outer surface of the lens
- CELLIGENT Technology assists with decreasing contact lens deposits and potential for bacterial bioburden
Any drops for contact lenses?
Yup! Just one, though:
Biotrue Hydration Boost Contact Lens Eye drops
- Launch date: June 2023
- Company: Bausch + Lomb
- Indication: temporary relief of burning and irritation due to eye dryness for up to 8 hours after instillation
- Key features:
- First and only preservative-free rehydrating drop in a multi-dose bottle
- Newest addition to the Biotrue product line of formulations with hyaluronan, antioxidants, glycerin, and electrolytes.
Nice! Anything else for dry eyes?
Two very different products—a softgel oral capsule and an eye mask—and a major FDA-approved dry eye drop.
Avenova Eye Health Support Oral Supplement with MaquiBright
- Launch date: March 2023
- Company: NovaBay Pharmaceuticals
- Purpose: to calm dry eye symptoms and provide eye health support
- Key features:
- Over-the-counter, softgel capsule containing natural triglyceride omega-3 oils and MaquiBright—a nutrient-rich, antioxidant-dense extract derived from the maqui berry (typically used to treat inflammation).
- Where can I find it?
- Launch date: June 2023
- Company: ZEISS Vision Care
- Purpose: provide eyelid stimulation for dry eye relief
- Key features:
- Three-layered, flexible, and soft ear-loop masks
- Applies gentle and moist heat
- Activated upon opening
- Where can I find it?
- Click here for purchasing options.
MIEBO (perfluorohexyloctane ophthalmic solution)
- Launch date: September 2023
- Company: Bausch + Lomb (via an agreement with Novaliq)
- Indication: to treat signs and symptoms of dry eye disease (DED)
- Recommended dosage:
- One drop administered four times a day (QID) into the affected eye(s).
- Recommended dosage:
- Key features:
- First and only DED treatment approved to directly target tear evaporation.
- Proprietary, water-free, non-steroidal, single-component, and preservative-free.
- Formulated with 100% perfluorohexyloctane.
- Where can I find it?
- Click here for details.
Let’s go back to NovaBay for a second … didn’t they launch a second product?
Good memory! Although, to clarify, this was a re-brand.
In September, the company acquired both the commercial rights to BioStem Technologies, Inc.’s Amniotic Tissue Allograft as well as the ability to rename/rebrand it. Which brings us to:Avenova Allograft
- (Re)launch date: September 2023
- Company: NovaBay Pharmaceuticals
- Purpose: provide a protective environment for the cornea and conjunctiva during the healing process—enabling a potential medium for rehabilitation of the ocular surface.
- Key features:
- Ultra-thin, ultra-light structural dehydrated tissue allograft
- Available via prescription only in three diameter sizes:
- 8 mm, 10 mm, 12 mm
- Where can I find it?
Switching over to the allergic conjunctivitis front …
Note: Verséa Ophthalmics launched two products in one announcement (talk about a two-for-one) ….
Tear-based Point-of-Care (T-POC) TOTAL Immunoglobulin (IgE) Immunoassay Kit and Lateral Flow Readers
- Launch date: July 2023
- Company: Verséa Ophthalmics (Verséa Health, Inc.)
- Purpose: Diagnose and manage ocular surface disease (OSD) patients and measure actual IgE levels in the tear film.
- Key features:
- Currently targets dry eye, contact lens wear, ocular allergy, and ocular surgery.
- Results available in less than 10 minutes.
- Billable CPT codes
- CPT code 82785: IgE Allergy Test
T-POC LACTOFERRIN Immunoassay test
- Launch date: July 2023
- Company: Verséa Ophthalmics (Verséa Health, Inc.)
- Purpose: Quantitative test for aqueous-deficient DED.
- Key features:
- Currently targets dry eye, ocular immunology, ocular allergy, and ocular surgery.
- Results available in less than 10 minutes.
- Shelf life of 12 months
- Billable CPT code
- CPT code 83520: Lactoferrin Test
Next up?
Bausch + Lomb’s specialty eye care products—LUMIFY EYE ILLUMINATIONS—and a major new FDA-approved product.
LUMIFY EYE ILLUMINATIONS 3-in-1 Micellar Cleansing Water and Eye Makeup Remover
- Launch date: July 2023
- Key features:
- Lash extension-friendly, no-rinse micellar formula containing hyaluronic acid, niacinamide, and Vitamin C
- Removes waterproof makeup without harsh rubbing
- pH-balanced for non-irritation.
LUMIFY EYE ILLUMINATIONS Nourishing Lash & Brow Serum
- Launch date: July 2023
- Key features:
- Formulated with peptides, panthenol (Vitamin B5), biotin (Vitamin B7), Vitamins E & C, hyaluronic acid, and botanicals
- Two-in-one serum softens and conditions lashes and brows overnight
LUMIFY EYE ILLUMINATIONS Hydra-Gel Brightening Eye Cream
- Launch date: July 2023
- Key features:
- Brightening and smoothing complex of caffeine, niacinamide, Vitamins E & C, and hyaluronic acid
To note, per B + L, these products are available online at all major national food, drugstore, and mass retailers.
Did you forget about IYUZEH?
Of course not! Particularly because it’s the first and only clinically-proven formulation of preservative-free latanoprost in the U.S.
IYUZEH (latanoprost ophthalmic solution) 0.005%
- Launch date: September 2023
- Company: Théa Pharmaceuticals
- Indication: for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT).
- Recommended dosage: One drop in the affected eye(s) once daily in the evening.
- Key features:
- Preservative-free formulation
- Has been available outside the U.S. for over 10 years in 46 countries under the brand name, MONOPROST
- Where can I find it?
- Via authorized distributors and five distributors/corresponding order numbers (click here for those).
Any honorable mentions?
Oh yes… here’s the timeline and product release list (including our coverage):
- January 2023
- PreserVision AREDS2 soft gel drops with OCUSorb (Bausch + Lomb)
- Europa Tangent scleral lens (Visionary Optics)
- February 2023
- iTrace Prime aberrometer (upgraded) (Tracey Technologies)
- Atoprine formulations: 0.05%, 0.01%, 0.025% (Harrow, Inc.)
- March
- Ergo-Series (for OMNI Surgical System) (Sight Sciences)
- Eyestar 900 corneal ectasia display (Haag-Streit AG)
- April
- Preloaded DMEK EndoGlide (Eversight)
- PASCAL platform with MicroPulse (Iridex)
- StableVisc OVD (Bausch + Lomb)
- TotalVisc Viscoelastic System (Bausch + Lomb)
- Tango Neo (Lumibird Medical)
- UltraQ Reflex Neo (Lumibird Medical)
- May
- Ilevro (nepafenac ophthalmic suspension 0.3%) (Harrow)
- Nevanac (nepafenac ophthalmic suspension 0.1%) (Harrow)
- Maxidex (dexamethasone ophthalmic suspension 0.1%) (Harrow)
- IHEEZO (chloroprocaine hydrochloride ophthalmic gel 3%) (Harrow)
- Cassini Connect (Cassini Technologies B.V.)
- MiYOSMART Chameleon (Hoya Vision Care)
- MiYOSMART Sunbird (Hoya Vision Care)
- June
- PreserVision AREDS2 formula mini soft gels with CoQ10 (Bausch + Lomb)
- July
- Vigamox (moxifloxacin hydrochloride ophthalmic solution 0.5%) (Harrow)
- September
- Brimonidine tartrate ophthalmic solution, 0.1% (Apotex Corp)
- Lucent IPL (OCULUS, LUVO)
- DARWIN IPL (OCULUS, LUVO)
- Virtual realty (VR)-based prescription lenses for MetaQuest 3 (Zenni Optical)
- SkyHy by Hubble contact lenses (Hubble)
- October
- FLAREX (fluorometholone acetate ophthalmic suspension 0.1%) (Harrow)
- NATACYN (natamycin ophthalmic suspension 5%) (Harrow)
- TOBRADEX ST (tobramycin/dexamethasone ophthalmic suspension 0.3%/0.05%) (Harrow)
- VERKAZIA (cyclosporine ophthalmic emulsion 0.1%) (Harrow)
- ZERVIATE (cetirizine ophthalmic solution 0.24%) (Harrow)
- enVista Aspire IOL (Bausch + Lomb)
- SeeNa ophthalmic diagnostic system (Bausch + Lomb)
- November
- OcuLenz Augmented Reality (AR) headset (Ocutrx)
- SmartCataract (Alcon)
- OptiPLUS radio frequency device (Lumenis)
- ZEPTOLink IOL Positioning System (Centricity Vision)
That’s quite the list.
Indeed it is. And to think: we haven’t even gotten started on 2023 FDA approvals (click here for those).