Phase IV

Ophthalmology

pain 42#47volume 277#64

Pain rank 47 of 76, volume rank 64 of 76 by industry trials. Trials here amend about 1.1x and fail enrollment about 0.7x the map median.

What this is worth

The amendment proxy, priced. Order of magnitude, anchor cited, assumptions on the table.

Per 100 industry trials in this cell, about 43 rewrite their eligibility criteria at least once. At the industry average of $450k direct cost per amendment, with the 6+ weeks of delay each not even counted, that is at least $19M at stake per 100 trials. Across the roughly 277 industry trials here, the floor is $54M.

If amendments fell by10%$5M30%$16M50%$27M

Assumes $450k direct cost per amendment (industry average; Phase II median runs lower, Phase III higher, and delay cost is excluded), applied to the proxy rate. The proxy counts only trials with at least one eligibility change, so this understates the true exposure. How this is derived.

The signals

Industry sponsors first, since that is the commercial buyer, each figure shown against the map median. All-sponsor figures follow. A trial counts as concluded once it has finished, whether completed, terminated or withdrawn.

Industry sponsors42pain index
Eligibility amendments
43%vs map 40%proxyn = 49sampled
Enrollment failure
10%vs map 13%n = 238concluded
Startup lag
43 dvs map 45.5 dn = 100with dates
Median duration
14.0 mon = 251completed
All sponsors25pain index
Eligibility amendments
29%proxyn = 94sampled
Enrollment failure
14%n = 687concluded
Startup lag
57 dn = 327with dates
Median duration
15.1 mon = 854completed
Why these trials stoppedlow accrual leads

The most common category here is low accrual (9 of 24 stopped). A keyword pass runs first; free text it could not place was sorted once by a frozen AI classification into these same categories, auditable rather than a live model. "No enrollment recorded (inferred)" is not a stated reason: it is read from a zero enrollment count, meaning the trial never enrolled anyone. "Not reported" means the sponsor left the field blank, shown rather than hidden.

Low accrual9 (38%)
Sponsor decision6 (25%)
Not reported3 (13%)
Safety or tolerability2 (8%)
Investigator decision or departure2 (8%)
No enrollment recorded (inferred)inferred1 (4%)
Business or funding1 (4%)
n = 24terminated or withdrawn
Evidence12 trials

A sample of terminated or withdrawn trials in this cell. Each links to its ClinicalTrials.gov record.

TrialSponsorStatusStated reason
NCT06407973Sight Sciences, Inc.terminatedSponsor decision
NCT06373653Laboratorios Sophia S.A de C.V.withdrawnSponsor decision
NCT06329687Oyster Point Pharma, Inc.terminatedSafety or tolerability
NCT03656692MallinckrodtterminatedSafety or tolerability
NCT02707120Biotechnology Institute IMASDwithdrawnLow accrual
NCT01514734Alcon ResearchterminatedLow accrual
NCT01514721Alcon ResearchterminatedLow accrual
NCT01249144Lenstec IncorporatedterminatedSponsor decision
NCT01241279Bausch & Lomb IncorporatedterminatedLow accrual
NCT01192321Alcon ResearchterminatedLow accrual
NCT01151904AllerganterminatedLow accrual
NCT01074606Alcon ResearchterminatedSponsor decision

Ophthalmology at other phases