With the whirlwind of a year that 2023 was, it’s almost unbelievable to think we’re in final countdown mode for 2024.
But before we kick off the new year, we’d be remiss if we didn’t give our readers a rundown on the plethora (and we do mean plethora) of activity that went down.
More specifically: FDA approvals.
So let’s take a little trip down memory lane for a look at this year’s latest additions to the ophthalmic space.
Where to start?
One of the hottest topics of 2023 came with two groundbreaking approvals for geographic atrophy (GA) secondary age-related macular degeneration (AMD):
- SYFOVRE (pegcetacoplan; Apellis Pharmaceuticals)
- Approved in February 2023 as the first medication for the treatment of GA secondary to AMD.
- Recommended dosage: 15 mg/ml dose intravitreally-injected once every 25 to 60 days
- Approved in February 2023 as the first medication for the treatment of GA secondary to AMD.
And, of course, we can’t forget the July 2023 announcement by the American Society of Retina Specialists (ASRS) regarding reported cases of occlusive and non-occlusive retinal vasculitis associated with the drug’s use. See here and here for the updates that followed.
- IZERVAY (avacincaptad pegol intravitreal solution; Iveric Bio, Inc., an Astellas Pharma Inc. company)
- Approved in August 2023
- Recommended dosage: 2 mg dose intravitreally-injected once a month for up to 12 months
- Approved in August 2023
More recently, in November 2023, 2-year data was released from the phase 3 GATHER2 trial that showed IZERVAY was well-tolerated following every-other-month (EOM) dosing.
Let’s stick with retina … anything new on the AMD front?
You betcha there is:
- EYLEA (aflibercept; Regeneron Pharmaceuticals, Inc. and Bayer AG)
- Approved in February 2023 as the first pharmacological treatment for retinopathy of prematurity (ROP) in preterm infants.
- Recommended dosage (specifically for ROP): 0.4 mg (0.01 mL or 10 microliters) intravitreally-injected with a treatment interval between doses injected into the same eye being at least 10 days.
- Of note, treatment may be administered bilaterally on the same day.
- Treatment can be repeatable.
- Marks the fifth FDA-approved indication to treat retinal conditions caused by ocular angiogenesis.
- Recommended dosage (specifically for ROP): 0.4 mg (0.01 mL or 10 microliters) intravitreally-injected with a treatment interval between doses injected into the same eye being at least 10 days.
- Approved in February 2023 as the first pharmacological treatment for retinopathy of prematurity (ROP) in preterm infants.
- EYLEA HD (aflibercept; Regeneron Pharmaceuticals, Inc. and Bayer AG)
- Approved in August 2023 for three retinal diseases:
- Wet AMD
- Diabetic macular edema (DME)
- Diabetic retinopathy (DR)
- Recommended dosage: 8 mg (0.07 mL of 114.3 mg/mL solution) dose intravitreally-injected every 4 weeks (+1 week) for the first three doses followed by:
- Wet AMD and DME
- 8 mg every 8 to 16 weeks (2 to 4 months, +1 week)
- DR
- 8 mg every 8 to 12 weeks (2 to 3 months, +1 week)
- Wet AMD and DME
- Recommended dosage: 8 mg (0.07 mL of 114.3 mg/mL solution) dose intravitreally-injected every 4 weeks (+1 week) for the first three doses followed by:
- Approved in August 2023 for three retinal diseases:
Now I know there were more retina approvals …
One more!
- VABYSMO (faricimab-svoa; Genentech, a member of the Roche Group)
- Approved in October 2023 to treat macular edema following retinal vein occlusion (RVO).
- Recommended dosage (specifically for RVO): 6 mg (0.05 mL of 120 mg/mL) dose intravitreally administered every 4 weeks—translating to an estimated 28 ± 7 days (monthly) for 6 months.
- Click here to see the positive, topline, long-term data from two phase 3 trials, released this past fall.
- Note: this medication was previously approved in 2022 as the first bispecific antibody for wet AMD and DME.)
- Approved in October 2023 to treat macular edema following retinal vein occlusion (RVO).
Moving on … let’s talk dry eye.
Funny you should mention … there were two key approvals:
- MIEBO (perfluorohexyloctane ophthalmic solution; Bausch + Lomb)
- Approved in May 2023 as the first prescription-based dry eye disease (DED) treatment that directly targets tear evaporation.
- Recommended dosage: One drop administered four times a day into the affected eye(s).
- Approved in May 2023 as the first prescription-based dry eye disease (DED) treatment that directly targets tear evaporation.
- VEVYE (cyclosporine ophthalmic solution 0.1%; Novaliq GmbH)
- Approved in June 2023 as the first and only cyclosporine solution indicated to treat DED.
- Recommended dosage: One drop administered twice a day (BID) in each eye, approximately 12 hours apart.
- To note, Harrow, Inc. purchased the U.S. and Canadian commercial rights to VEVYE in July 2023.
- Approved in June 2023 as the first and only cyclosporine solution indicated to treat DED.
Didn’t we have some Demodex blepharitis news, too?
Absolutely! Yet another significant first, in fact.
- XDEMVY (lotilaner ophthalmic solution 0.25%; Tarsus Pharmaceuticals, Inc.)
- Approved in July 2023 as the first and only therapeutic that directly targets Demodex blepharitis.
- Recommended dosage: One drop instilled in each eye twice daily (approximately 12 hours apart) for 6 weeks.
- Approved in July 2023 as the first and only therapeutic that directly targets Demodex blepharitis.
Speaking of drops, I could’ve sworn we had a few presbyopia approvals as well …
We definitely did. Approved 7 months apart, these include:
- VUITY (pilocarpine hydrochloride ophthalmic solution 1.25%; Allergan, an AbbVie company)
- Approved in March 2023 as a twice-daily prescription eye drop for presbyopia (note: it was previously approved in 2021 as the first and only once-daily prescription drop).
- Recommended dosage: twice-daily drop where the second dropcan be administered 3 to 6 hours following the first dose, extending its duration of effect to up to 9 hours.
- Approved in March 2023 as a twice-daily prescription eye drop for presbyopia (note: it was previously approved in 2021 as the first and only once-daily prescription drop).
- QLOSI (pilocarpine hydrochloride ophthalmic solution 0.4%; Orasis Pharmaceuticals)
- Approved in October 2023 as a preservative-free formulation of low-dose pilocarpine.
- Recommended dosage: one drop in each eye can be used daily or as needed (with dosings up to twice a day, 2 to 3 hours apart) with a duration of activity up to 8 hours.
- Approved in October 2023 as a preservative-free formulation of low-dose pilocarpine.
Give me a mydriasis update.
Certainly —I’ll give you two updates, in fact.
- MYDCOMBI (tropicamide and phenylephrine hydrochloride ophthalmic spray 1% / 2.5%; Eyenovia, Inc.)
- Approved in May 2023 as a fixed-dose combo product of tropicamide and phenylephrine for inducing mydriasis.
- Recommended dosage: Developed as a micro-formulation to be used sans anesthetic and administered with Eyenovia’s proprietary Optejet device platform.
- Approved in May 2023 as a fixed-dose combo product of tropicamide and phenylephrine for inducing mydriasis.
- RYZUMVI (phentolamine ophthalmic solution 0.75%; Ocuphire Pharma, Inc. and Viatris Inc.)
- Approved in September 2023 as the first commercially available treatment option in the United States indicated for the reversal of mydriasis (RM).
- Recommended dosage:
- For adult and pediatric patients (age 12+):One to two drops are to be instilled in each dilated eye following the completion of an ophthalmic exam or procedure to reverse mydriasis.
- For pediatric patients (ages 3 to 11):One drop is to be instilled in each dilated eye following completion of an ophthalmic exam or procedure to reverse mydriasis.
- Recommended dosage:
- Approved in September 2023 as the first commercially available treatment option in the United States indicated for the reversal of mydriasis (RM).
I’m sensing a corneal sensitivity diagnostic approval …
You sensed right.
- Corneal Esthesiometer Brill ([CEB], Brill Engines, S.L., a subsidiary of Brill Pharma)
- Approved in July 2023, the CEB is a first-of-its-kind portable and non-invasive device designed to measure corneal sensitivity.
- Indication: to detect subclinical dysesthesia and related pathologies related to the ophthalmic branch of the trigeminal nerve (cranial nerve V) such as neurotrophic keratitis (NK), herpes simplex keratitis (HSK), diabetic keratopathy, and more.
- Approved in July 2023, the CEB is a first-of-its-kind portable and non-invasive device designed to measure corneal sensitivity.
And lastly?
Just last week, the FDA slid in in a final approval:
- iDose TR (travoprost intraocular implant) 75 mcg (Glaukos Corporation)
- Approved in December 2023, it's a biocompatible titatnium implant designed to be administered during invasive glaucoma procedures.
- Indication: to address ubiquitous patient non-compliance and chronic side effects associated with topical glaucoma medications
- Approved in December 2023, it's a biocompatible titatnium implant designed to be administered during invasive glaucoma procedures.
- Provides long-term drability and removability capabilities as a first-of-its-kind dropless alternative to daily eye drops for open-angle glaucoma (OAG) and ocular hypertensive (OHT) patients.
That’s quite an update on approvals.
Indeed it is. And to think: we haven’t even gotten started on commercial product launches. But we’ll save that for another time…