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The global ophthalmic drugs market is expected to increase from $34 billion in 2019 to $68.
1 billion in 2030.
1 billion in 2030.
Among them, dry eye syndrome as the most common eye disease, the market share will also increase: 5%~50% of people in the world suffer from dry eye, and the prevalence increases significantly with age
.
In this case, dry eye drugs have become a "battleground"
.
.
Aldeyra announced that it has submitted a new drug application
for reproxalap eye drops for the treatment of dry eye syndrome to the FDA.
If approved, reproxalap will be the world's first commercially available reactive aldehyde modulator
(RASP).
Dry eye drug war ignites, who can come out on top?
Dry eye drug war ignites, who can come out on top?Dry eye predisposing factors
Dry eye predisposing factorsThe predisposing factors of dry eye syndrome are mainly divided into high predisposing factors, moderate predisposing factors and low predisposing factors, such as vitamin A deficiency, corneal transplantation and smoking, etc.
, which may increase the risk
of dry eye.
Figure 1 Predisposing factors of dry eye Picture source: Reference 1
Its clinical symptoms are usually non-specific and mainly include the following: eye redness, hot burning, tingling, foreign body sensation, itching, photophobia, etc
.
At present, there are two common treatments for dry eye:
At present, there are two common treatments for dry eye:Artificial tears
Artificial tearsThe commonly used treatment for dry eye is artificial tears, which have the effect
of increasing the stability of tear film, reducing ocular surface pressure, improving tear hyperosmolation and repairing ocular surface damage.
However, artificial tears generally contain preservatives, which are cytotoxic to human corneal cells, human conjunctival cells and rabbit corneal cells, and the price of artificial tears without preservatives is relatively high, so the use of artificial tears is also limited
overall.
Anti-inflammatory therapy
Anti-inflammatory therapyIn patients with moderately severe dry eye, the ocular surface and lacrimal glands are usually inflamed, so patients with moderate to severe dry eye often require anti-inflammatory therapy
.
The limited treatment options make the market for dry eye drugs increasingly attractive
.
.
Reproxalap takes the lead in "blowing the trumpet"
Reproxalap takes the lead in "blowing the trumpet"In June, Aldeyra announced that a Phase 3 clinical trial of reproxalap, a new drug for the treatment of dry eye, met its primary endpoint
.
That is, one day after dosing, Schirmer test (p=0.
0001) and ≥ 10 mm
In the Schirmer test, reproxalap was statistically superior to the vector
.
(The Schirmer test, a measure of intraocular tear secretion, is one of the most commonly used indicators of
drug approval for dry eye.
) ）
Figure 2 Schirmer test and ≥ 10 mm Schirmer test Image source: Reference 2
Reproxalap, also known as ADX 102 or NS-2, is a small molecule inhibitor developed by Aldyra
Developed by Therapeutics for the treatment of dry eye as well as diseases
such as allergic conjunctivitis.
Reproxalap is an active aldehyde inhibitor that treats eye diseases
primarily by binding and trapping free aldehydes.
The figure below shows some of the predictive properties of reproxlap (source DrugBank).
Figure 3 Reproxalap property prediction Image source: DrugBank
The success of reproxalap clinical phase III also indicates that reproxalap is about to enter the market
.
On November 29, Aldeyra formally submitted a marketing application for reproxalap to the FDA, and if it is normally approved, it can be approved within 10 months
.
.
Since Reproxalap is the first active aldehyde modifier on the market, providing a new treatment option for dry eye patients, the market "fire" has ignited
.
How are dry eye medications going?
How are dry eye medications going?At present, in addition to the marketing application submitted by Reproxalap, there are several models that are in the clinical phase 3 stage to look forward to:
timbetasin
timbetasintimbetasin was developed by RegeneRx to treat dry eyes
.
According to clinical data compared with placebo, 0.
1% TIMbetasin can have a better therapeutic effect on dry eye patients, and the safety of the drug and the patient's compliance are better
.
Compared with placebo, TIMbetasin significantly reduced eye discomfort and corneal fluorescein staining without adverse effects
in all participants.
tavilermide
tavilermideTavilermide is a small molecule nerve growth factor mimetic peptide developed by Mimetogen as a tropomyosin receptor kinase receptor agonist and a mucin-secreting agent
.
Currently, the drug is in phase III clinical studies for the indication of dry eye
.
In previous clinical studies, patients with dry eye received 1% and 5% tavilermide, respectively, and the results showed that both low and high doses of tavilermide had good safety and tolerability
compared with placebo.
BRM421
BRM421BRM421 is made by BRIM
Developed by Biotechnology, this drug can accelerate the division and proliferation of limbal stem cells, promote ocular surface repair to treat dry eye, and promote corneal repair
.
And the clinical phase II.
and III data of the drug prove that the drug is safe and effective, and the irritation to patients is small
.
If it is approved for listing in the future, it will inevitably seize a certain market
.
PL-9643
PL-9643PL-9643 was developed by Palatin, which officially announced the critical success of Phase III on August 16
, 2022.
In trials treating people with moderate to severe dry eye, no safety concerns
were identified.
Tivanisiran
TivanisiranTivanisiran was developed by Sylentis, a double-stranded siRNA used primarily to treat dry eyes
.
Tivanisiran's clinical phase II and III data show that 1.
125% Tivanisiran can significantly reduce eye discomfort and pain, and improve conjunctival hyperemia in dry eye patients, with good
safety.
NOV03
NOV03NOV03 is developed by Novaliq in Germany, which is the world's first anhydrous drug delivery technology platform EyeSol, NOV03 can form a stable envelope on the surface of the eye and prevent excessive evaporation of tears to treat excessive evaporation of dry eye associated with meibomian gland dysfunction
.
The phase III clinical trial of NOV03 also reached the primary endpoint, and it is expected that an NDA
will be submitted this year or next year.
It is worth noting that in November 2019, Hengrui Pharmaceutical introduced NOV03
from Novaliq.
brief summary
brief summaryDry eye is a common chronic ophthalmic condition that plagues many patients
due to slow treatment.
Therefore, the market for dry eye will become larger and larger in the future, but the competition will also be more intense
.
It is expected that companies can develop more safe and effective drugs to provide patients with more reliable treatment options
.
References
References
[1] Messmer Elisabeth M,The pathophysiology,diagnosis,and treatment of dry eye
disease.
[J].
Dtsch Arztebl Int,2015,112:71-81; quiz 82.
[J].
Dtsch Arztebl Int,2015,112:71-81; quiz 82.
[2] Aldeyra Therapeutics Achieves Primary Endpoint in Phase 3 TRANQUILITY‑2
Trial in Dry Eye Disease and Intends to Submit New Drug Application for Symptoms
and Three Sign Endpoints of Dry Eye Disease.
[3] HUANG Zhen.
Say "goodbye" to dry eye syndrome[J].
Going to the World,2021(34):4.
)
Say "goodbye" to dry eye syndrome[J].
Going to the World,2021(34):4.
)
[4] FANG Miao, WANG Degang, LIU Peiqing.
Research progress on the medication of dry eye syndrome[J].
World Clinical Drugs,2022(005):043.
)
Research progress on the medication of dry eye syndrome[J].
World Clinical Drugs,2022(005):043.
)
